Clinical Follow-up Study Research Articles

Long-term outcomes of a cemented bipolar radial head prosthesis: a large retrospective study

BackgroundIn acute radial head (RH) fractures (RHFs), an RH prosthesis can be considered if open reduction and internal fixation are not technically feasible.This study provides the largest long-term clinical and radiological follow-up study of cemented bipolar Judet prostheses implanted to manage acute RHFs, either isolated (IRHFs) and associated with other elbow fractures (ARHFs). We compare their functional and radiographic outcomes to test the hypothesis that the bipolar design can achieve similar results in both groups. MethodsWe reviewed the data of 63 consecutive patients implanted with a bipolar prosthesis (The articulation between the stem and the cup is semiconstrained and gives the radial cup a double range of movement) to treat unreconstructable RHFs with/without other fractures. Fifty-two patients had more than 10-year follow-up. Assessments included range of motion and stability using the Mayo Elbow Performance Score (MEPS) and the QuickDash questionnaire score, pain with a visual analog scale, and overall satisfaction with an interview.X-rays were examined to check the correct seating of the implant and periprosthetic loosening, prosthetic disassembly, heterotopic ossification, and capitellum and ulnohumeral degenerative changes. ResultsAt a mean follow-up of 150 months, 90% of patients were satisfied, with a mean MEPS of 89 (range, 70-100) and a mean QuickDash score of 6.8 (range, 0-18.2). The mean arc of motion was 113° (range, 70°-140°) in flexion-extension and 149° (range, 100°-160°) in pronation-supination. Nineteen patients (30%) patients required reoperation in the first 3 years. ConclusionsThe bipolar Judet prosthesis is a viable implant for acute irreducible RHFs. Clinical and radiological outcomes and complications leading to reoperation were not significantly different between IRHF and ARHF patients.

In vivo prospective randomised study of the wear of dental restorations using an intraoral scanner and its correlation with visual assessment.

Objectives: To evaluate the efficacy of the True Definition®intraoral scanner in quantifying the wear of the glass ionomer restorative material (KetacTM Universal and KetacTM Molar) over 1 year. We also studied the correlation between visual and digital assessments of restoration wear. Materials and Methods: This was a clinical follow-up study of a post-marketed material with a prospective, controlled, randomised, split-mouth, and blinded assessment design. Intraoral optical impression and visual assessment were carried out over three appointments over 12 months, starting with 36 patients.Results: According to the visual indices, all restorations in this study were clinically healthy. However, in the digital measurement of wear, 94.74% and 94.44% of the restorations during the T0-T6 and T6-T12 observation periods, respectively, showed deterioration greater than 41 microns. Moreover, in the analysis of agreement between measurement techniques, no agreement was obtained in the two analysed time periods: T0-T6 yielded a kappa (k) value of 0.000, and T6-T12 yielded k=0.0030. Discordant results were obtained in the correlation analysis. In T0-T6, the results were not considered statistically significant (p=0.838); however, the results obtained during T6-T12 showed a correlation (p-value <0.001).Conclusions: The wear of dental materials as observed by the human eye did not agree with that observed by intraoral scanning. The scanner effectively measures wear, detecting details that are beyond the capability of the human eye and conventional photographs. The surface deterioration of the restorations at both observation times can be considered non-physiological, potentially leading to premature occlusal alterations and accelerated physiological ageing.Clinical Relevance: Early diagnosis is crucial for avoiding alterations in the function of the stomatognathic system due to the wear of dental restorations. Additionally, since most of the tools applied are qualitative in nature, such as visual inspection, it is essential to find a standardised and precise tool that offers diagnosis, monitoring, and records of the evolution of tooth wear. This study has been registered at https://www.ClinicalTrials.gov, under the identifier NCT06275581.

Maxilla reconstruction with 100% BioOss: A clinical and tomographic follow-up study.

Tooth loss and use of a complete denture is still a reality and results in bone loss. Adequate reconstruction of an extremely atrophic edentulous maxilla is a challenge, and different treatment methods have been described for its resolution. Patients seeking implant placement in edentulous upper jaw with atrophic maxilla were selected in a private clinic in Porto Alegre, Brazil. The bone graft was performed with bilateral sinus lift and horizontal bone graft in anterior region with 0,25-1mm particles of Bio-Oss (Geistlich) covered with a collagen membrane (Bio-Gide, Geistlich). CBCTs were evaluated to verify the need for bone graft, and 6-8 months after bone graft follow-up, to plan implant placement and assess horizontal bone gain. 124 implants were placed in 19 patients, 76 of those in the sinus region. The survival rate was 95.2%, with six implants lost over a mean implants follow-up time of 47.68 months. The horizontal bone gain ranged from 0.00 to 6.86 mm, a mean gain of 2.85mm. An average of 5.5g of Bio-Oss was used per patient, and in 73.7 % of the cases, a flapless surgery was possible for implant placement, and in 92 implants an immediate loading was possible. Final rehabilitation was accomplished with fixed prosthodontics in 16 patients with a mean follow-up of 38.4 months. Within the limitations of this study, it is possible to affirm that bone graft with 100% Bio-Oss in atrophic maxilla is a reliable treatment and allow rehabilitation with implants with a high survival rate and the higher the initial bone height, the greater the gain in bone width. Key words:Bone Regeneration, Dental Implants, Prosthodontics, Dentistry.

A Retrospective, Multicenter, Observational Real World Post Market Clinical Follow Up Study to Evaluate Acute Safety and Device Procedural Success of ADVAMRYL (Poliglecaprone 25) Surgical Suture. (ADVAMRYL PMCF Study)

In this real-world experience Post-Marketing Clinical Follow-up study conducted in accordance with EU MDR 2017/745 in 70 subjects from &gt;60 surgical centers across various surgical specialties, ADVAMRYL (Poliglecaprone 25) monofilament, synthetic absorbable sterile surgical sutures demonstrated excellent suture, needle, and overall performance. No wound complications or adverse events were reported in this study during the follow-up period of 3 months, and there were no reports of prolonged or repeat hospitalization. ADVAMRYL (Poliglecaprone 25) sutures are a safe and effective option for a very wide variety of surgical procedures in a diverse population.

A Retrospective, Multicenter, Observational Real World Post Market Clinical Follow up Study to Evaluate Acute Safety and Device Procedural Success of ADVACRYL RAPID (Braided Coated Polyglactin 910) Surgical Suture. (ADVACRYL RAPID PMCF Study)

In this real-world experience Post-Marketing Clinical Follow-up study conducted in accordance with EU MDR 2017/745 in 70 subjects from &gt;50 surgical centers across various surgical specialties, ADVACRYL RAPID (Polyglactin 910) braided, synthetic absorbable sterile surgical sutures demonstrated excellent suture, needle, and overall performance. No wound complications or adverse events were reported in this study during the follow-up period of 3 months, and there were no reports of prolonged or repeat hospitalization. ADVACRYL RAPID (Braided coated Polyglactin 910) sutures are a safe and effective option for a very wide variety of surgical procedures in a diverse population.

A Retrospective, Multicenter, Observational Real World Post Market Clinical Follow Up Study to Evaluate Acute Safety and Device Procedural Success of ADVALENE (Polypropylene) Surgical Suture. (ADVALENE PMCF Study)

In this real-world experience Post-marketing Clinical Follow-up study conducted in accordance with EU MDR 2017/745 in 80 subjects from &gt;65 surgical centers across various surgical specialties, ADVALENE (Polypropylene) monofilament, synthetic, non-absorbable sterile surgical sutures demonstrated excellent suture, needle, and overall performance. No wound complications or adverse events were reported in this study during the follow-up period of 3 months, and there were no reports of prolonged or repeat hospitalization. ADVALENE (Polypropylene) sutures are a safe and effective option for a very wide variety of surgical procedures in a diverse population.

A Retrospective, Multicenter, Observational Real World Post Market Clinical Follow Up Study to Evaluate Acute Safety and Device Procedural Success of ADVALON (Polyamide) Surgical Suture. (ADVALON PMCF Study)

In this real-world experience Post-Marketing Clinical Follow-up study conducted in accordance with EU MDR 2017/745 in 80 subjects from &gt;70 surgical centers across various surgical specialties, ADVALON (Polyamide) monofilament, synthetic, non-absorbable sterile surgical sutures demonstrated excellent suture, needle, and overall performance. No wound complications or adverse events were reported in this study during the follow-up period of 3 months, and there were no reports of prolonged or repeat hospitalization. ADVALON (Polyamide) sutures are a safe and effective option for a very wide variety of surgical procedures in a diverse population.

A Retrospective, Multicenter, Observational Real World Post Market Clinical Follow Up Study to Evaluate Acute Safety and Device Procedural Success of ADVAPD (Polydioxanone) Surgical Suture. (ADVAPD PMCF Study)

In this real-world experience Post-marketing Clinical Follow-up study conducted in accordance with EU MDR 2017/745 in 70 subjects from &gt;55 surgical centers across various surgical specialties, ADVAPD (Polydioxanone) monofilament, synthetic absorbable sterile surgical sutures demonstrated excellent suture, needle, and overall performance. No wound complications or adverse events were reported in this study during the follow-up period of 3 months, and there were no reports of prolonged or repeat hospitalization. ADVAPD (Polydioxanone) sutures are a safe and effective option for a very wide variety of surgical procedures in a diverse population.

A Retrospective, Multicenter, Observational Real World Post Market Clinical Follow Up Study to Evaluate Acute Safety and Device Procedural Success of ADVACRYL PLUS (Triclosan Coated Triclosan Coated Polyglactin 910) Surgical Suture. (ADVACRYL PLUS PMCF Study)

In this real-world experience Post-Marketing Clinical Follow-up study conducted in accordance with EU MDR 2017/745 in 103 subjects from &gt;80 surgical centers across various surgical specialties, ADVACRYL PLUS (Triclosan Coated Polyglactin 910) braided, synthetic absorbable sterile surgical sutures demonstrated excellent suture, needle, and overall performance. No wound complications or adverse events were reported in this study during the follow-up period of 3 months, and there were no reports of prolonged or repeat hospitalization. ADVACRYL PLUS (Triclosan Coated Polyglactin 910) sutures are a safe and effective option for a very wide variety of surgical procedures in a diverse population

The Effect of High-Dose Erythropoietin Perinatally on Retinal Function in School-Aged Children Born Extremely or Very Preterm

To investigate the long-term effects of high-dose recombinant human erythropoietin (rhEPO) administered during the perinatal period on retinal and visual function in children born extremely or very preterm. Randomized, double-blind clinical trial follow-up plus cohort study. Setting: Department of Ophthalmology, University Hospital Zurich, Zurich, Switzerland. Extremely or very preterm-born children aged 7 to 15 years, previously randomized to receive either high-dose rhEPO or placebo in the perinatal period. participation in an ongoing neuropediatric study (EpoKids), written informed consent. previous ocular trauma or surgery; retinal or developmental disease unrelated to prematurity. Healthy control (HC) children of comparable age were recruited. term birth, informed consent. any ocular/visual abnormality, high refractive error. Intervention status (rhEPO/placebo) was unknown to examiners and subjects at examination, with examiners unblinded only after completion of all analyses. The electroretinogram (ERG) was performed with the RETeval device (LKC Technologies, Inc). Ophthalmological and orthoptic examinations excluded comorbidity in the prematurely born cohort and ocular diseases in the HC group. Scotopic and photopic ERG response amplitudes and peak times (6 amplitudes; 6 peak times). Secondary outcomes were habitual visual acuity and color discrimination performance (for descriptive summary only). No differences in ERG parameters between EPO (n = 52; 104 eyes) and placebo (n = 35; 70 eyes) subgroups were observed (all corrected P > .05). Two cone system-mediated peak times were slightly slower in the placebo than HC (n = 52; 104 eyes) subgroup (coefficient/95% confidence interval = 0.53/0.21-0.85 and 0.36/0.13-0.60; P = .012 and .022); a predominantly rod system-mediated peak time was slightly faster in the EPO than the HC subgroup (coefficient/95% confidence interval = -4.33/-6.88 to -1.78; P = .011). Secondary outcomes were comparable across subgroups. Administration of high-dose rhEPO to infants born extremely or very preterm during the perinatal period has no measurable effects on retinal function in childhood compared to placebo. Premature birth may cause small, likely clinically insignificant effects on retinal function in childhood, which may be partially mitigated by administration of rhEPO during the perinatal period.

The Effect of Perinatal High‐Dose Erythropoietin on Retinal Structural and Vascular Characteristics in Children Born Preterm

To study the long-term effects of perinatal high-dose recombinant human erythropoietin (rhEPO) on macular structural and vascular development in preterm children. Randomized, double-blind clinical trial follow-up plus cohort study. Setting: Department of Ophthalmology, University Hospital Zurich, Zurich, Switzerland. extremely or very preterm born children aged 7-15 years from an ongoing neuropediatric study (EpoKids). These had been previously randomized to receive either high-dose rhEPO or placebo perinatally. participation in the EpoKids Study, written informed consent (IC). previous ocular trauma or surgery; retinal or developmental disease unrelated to prematurity. Term-born children of comparable age were enrolled as a healthy control (HC) group. term birth, IC. any ocular or visual abnormality, high refractive error. Examiners were blinded regarding intervention status until completion of all analyses. (Participants/guardians remain blinded). Spectral-domain OCT scans (Heidelberg Spectralis system) and OCTA imaging (Zeiss PlexElite 9000) were obtained. Ophthalmological and orthoptic examinations excluded ocular comorbidities. OCT (central retinal thickness, CRT; total macular volume, TMV), superficial plexus OCTA (foveal avascular zone, FAZ; vessel density, VD; vessel length density, VLD) parameters and foveal hypoplasia grade according to published criteria. Macular vessel density parameters (VD and VLD) were significantly lower (p =0.015, CI-95: 0.01 to 0.06 and p=0.015, CI-95: 0.74 to 3.64) in the EPO group (n= 52) when compared to placebo (n=35). No other significant differences were observed between the EPO and placebo group. When comparing the intervention subgroups to HC we found six significant differences in OCT and OCTA parameters (FAZ, VD, VLD and CRT comparing HC and EPO group; FAZ and CRT when comparing HC and placebo group). Early high-dose rhEPO in infants born extremely or very preterm affects macular vessel density parameters compared to placebo. Premature birth (regardless of intervention status) affects retinal structure and vascular development. Our findings on macular vascular development do not contraindicate the administration of early high-dose EPO in preterm infants. For further understanding of the role of EPO on macular development and its clinical significance, future studies are needed.

A 5-Year Follow-up Clinical Study of the B-cell Maturation Antigen Chimeric Antigen Receptor T-cell Therapy HDS269B in Patients with Relapsed or Refractory Multiple Myeloma.

This study aimed to report the 5-year clinical outcomes of anti-B-cell maturation antigen chimeric antigen receptor (CAR) T-cell (HDS269B) therapy in patients with relapsed/refractory multiple myeloma (RRMM), including those with poor performance status [Eastern Cooperative Oncology Group (ECOG) scores 3 to 4], and to identify factors influencing long-term outcomes. Forty-nine patients with RRMM enrolled from 2016 to 2020 received HDS269B (9 × 106 cells/kg) after receiving a conditioning chemotherapy consisting of cyclophosphamide and fludarabine. The overall response, long-term outcomes, and safety were assessed, as were their associations with clinical and disease characteristics. With a median follow-up of 59.0 months, the overall response rate was 77.55%. The median progression-free survival (PFS) and overall survival (OS) were 9.5 months [95% confidence interval (CI), 5.01-13.99] and 20.0 months (95% CI, 11.26-28.74), respectively. The 5-year PFS and OS rates were 21.3% (95% CI, 12.3%-36.7%) and 34.1% (95% CI, 22.7%-51.3%), respectively. Patients with ECOG 0 to 2 had marked longer survival, with a median PFS of 11.0 months and a median OS of 41.8 months. Early minimal residual disease negativity, higher and persistent CAR T-cell expansion, and the absence of extramedullary disease were associated with better survival outcomes. No new CAR T-cell therapy-associated toxicities were observed. Importantly, ECOG scores 0 to 2, prior therapy lines <4, and CAR T-cell persistence at ≥6 months were independently associated with longer OS. HDS269B is effective and safe, especially for patients with ECOG scores 0 to 2. Early CAR T-cell intervention may improve prognosis in patients with RRMM.

Effectiveness of low-viscosity resin infiltration (Icon) on color change of enamel white spot lesions: 1-year follow-up clinical study

BackgroundTo evaluate the effect of the low-viscosity Icon resin infiltrate application on the color change of white spot enamel lesions (WSLs) over 3-, 6-, and 12-m follow-up periods.MethodsNinety-six teeth diagnosis with WSLs using the ICDAS scoring system in 49 participants were assessed for their color change using the Icon resin infiltration technique. The Icon kit was applied to WSLs as instructed by the manufacturer. Icon-Etch (15% hydrofluoric acid) was applied to the lesions for 2 min, and then, it was rinsed off with copious amount of water for 30 s. Then, Icon-Dry (99% ethanol) was applied to the etched lesions for 30-s followed by the application of the Icon resin infiltrate that was light cured for 40 s. Color change assessment was performed using Vita Easyshade V spectrophotometer at baseline and immediately after Icon resin infiltration, then at 3-, 6-, and 12-m follow-up periods. Analysis of the data was performed using the test of repeated measure ANOVA and the paired sample t test.ResultsThere was a statistically significant difference in ∆E between the different follow-up periods at immediate, 3-m, 6-m, and 12-m. The highest mean value was found in the immediate follow-up period, while the lowest mean value was found in 12-m follow-up period.ConclusionsLow-viscosity Icon resin infiltration has the ability for immediate diffusion into the WSLs giving an immediate improvement in the esthetic outcome of the WSLs. However, its long-term outcomes might not be consistent for the color change of the WSLs.

Noninvasive Prenatal Test Results Indicative of Maternal Malignancies: A Nationwide Genetic and Clinical Follow-Up Study

The author describes the results and implications of a study on noninvasive prenatal test results that indicate maternal malignancies.

Scapholunate Ligament Reconstruction With Internal Brace Augmentation Techniques for Chronic Scapholunate Dissociation: A Clinical Follow-up Study.

The scapholunate ligament is the most important stabilizer of the scapholunate articulation. The management of chronic irreversible injuries of this ligament in the absence of preexisting arthritis of the wrist joint remains controversial. Recently, surgeons introduced a novel surgical technique using an internal brace (IB). Several biomechanical studies on this technique have been conducted using cadavers; however, very few studies have discussed the results in detail in actual clinical practice. Therefore, herein, we investigated the radiological and functional results of patients who underwent IB augmentation as a treatment for chronic scapholunate dissociation. This retrospective study was conducted from April 2018 to May 2022. Twenty-two patients with chronic scapholunate dissociation were treated using the IB augmentation technique, of whom 17 were followed-up for at least 1 year. Radiological results, including scapholunate distance, scapholunate angle, and radioscaphoid angle, were collected. Furthermore, clinical parameters, such as the visual analog scale (preoperative and at final follow-up), the Disabilities of the Arm, Shoulder, and Hand scores (preoperatively and at 3, 6, and 12 months postoperatively), and Mayo wrist scores (preoperative and at final follow-up), were measured. The scapholunate distance increased significantly in the affected wrist compared to the unaffected wrist, which improved after reconstruction in all wrist positions ( P < 0.05). Compared to the unaffected wrist, the scapholunate angle increased significantly in all positions ( P < 0.05) except for extension ( P = 0.535) and improved after reconstruction in all wrist positions. The radioscaphoid angle significantly increased compared to the angle of the unaffected wrist in all positions ( P < 0.05) except for extension ( P = 0.602) and clenched fist ( P = 0.556). This angle improved after reconstruction in all wrist positions except for extension ( P = 0.900). The visual analog scale score (7-2, preoperatively and at final follow-up) and Mayo wrist score (53-82, preoperatively and at final follow-up) improved after surgery. The Disabilities of the Arm, Shoulder, and Hand scores also improved after surgery (68, 53, 30, 7, preoperatively and at 3, 6, and 12 months postoperatively). This study revealed that scapholunate ligament reconstruction using an autologous tendon and suture tape is a good reconstruction technique that can improve clinical symptoms and radiographic parameters with a shorter operation time and fewer complications than other reconstruction methods.

Clinical features and follow-up study on 55 patients with adolescence-onset methylmalonic acidemia

Objective: To investigate the clinical features and outcomes of adolescence-onset methylmalonic acidemia (MMA) and explore preventive strategies. Methods: This was a retrospective case analysis of the phenotypes, genotypes and prognoses of adolescence-onset MMA patients. There were 55 patients diagnosed in Peking University First Hospital from January 2002 to June 2023, the data of symptoms, signs, laboratory results, gene variations, and outcomes was collected. The follow-ups were done through WeChat, telephone, or clinic visits every 3 to 6 months. Results: Among the 55 patients, 31 were males and 24 were females. The median age of onset was 12 years old (range 10-18 yearsold). They visited clinics at Tanner stages 2 to 5 with typical secondary sexual characteristics. Nine cases (16%) were trigged by infection and 5 cases (9%) were triggered by insidious exercises. The period from onset to diagnosis was between 2 months and 6 years. Forty-five cases (82%) had neuropsychiatric symptoms as the main symptoms, followed by cardiovascular symptoms in 12 cases (22%), kidney damage in 7 cases (13%), and eye disease in 12 cases (22%). Fifty-four cases (98%) had the biochemical characteristics of methylmalonic acidemia combined with homocysteinemia, and 1 case (2%) had the isolated methylmalonic acidemia. Genetic diagnosis was obtained in 54 cases, with 20 variants identified in MMACHC gene and 2 in MMUT gene. In 53 children with MMACHC gene mutation,1 case had dual gene variants of PRDX1 and MMACHC, with 105 alleles. The top 5 frequent variants in MMACHC were c.482G>A in 39 alleles (37%), c.609G>A in 17 alleles (16%), c.658_660delAAG in 11 alleles (10%), c.80A>G in 10 alleles (10%), c.567dupT and c.394C>T both are 4 alleles (4%). All patients recovered using cobalamin, L-carnitine, betaine, and symptomatic therapy, and 54 patients (98%) returned to school or work. Conclusions: Patients with adolescence-onset MMA may triggered by fatigue or infection. The diagnosis is often delayed due to non-specific symptoms. Metabolic and genetic tests are crucial for a definite diagnosis. Treatment with cobalamin, L-carnitine, and betaine can effectively reverse the prognosis of MMA in adolescence-onset patients.

The Efficacy of a Metacognitive Training Program in Amnestic Mild Cognitive Impairment: A 6-Month Follow-Up Clinical Study.

This study was conducted in response to the increasing prevalence of Alzheimer's disease (AD) dementia and the significant risk faced by individuals with amnestic mild cognitive impairment with multiple-domain deficits (aMCI-md). Given the promising effects of MTPs, the primary aim of this study was to further explore their impact by assessing the maintenance of their benefits. Thus, 45 participants were randomly allocated in two groups: the Experimental group (n = 22), which received the metacognitive training program (MTP), and the Control group (n = 23) that received the cognitive exercises program (CEP). The training programs-the MTP and the CEP-included 10 individual sessions of a one-hour duration and took place once per week. To test the efficacy of the MTP, cognitive and metacognitive outcomes were compared between two groups-Experimental (EG) and Control (CG)-at four distinct time points: before-after-3 months-6 months after intervention. Based on this study's findings, the positive effects of the MTP were evident over a six-month period. Specifically, already three months post-training, the CG began to show a decline in training-related gains. In contrast, the EG's performance consistently improved, highlighting the superior efficacy of the MTP. Gains attributed to the MTP were detected in cognitive measures: cognitive flexibility and immediate visual recall, as well as in metacognitive measures: metacognitive control, improved metacognitive beliefs of attention, and an increased use of cognitive strategies. In conclusion, the results demonstrated the sustained effects of the MTP in cognitive and metacognitive measures over a period of six months, providing novel insight into the application and efficacy of the MTP in individuals with MCI.

POLARIS: efficacy and safety of a vaginal medical device in recurrent bacterial vaginosis-a multicenter, open-label, non-controlled, study with 10 months of follow-up.

Recurrent bacterial vaginosis (RBV) after antibiotic treatment has relapse rates of 35% within 3 months and 60% within 12 months. A medical device containing polycarbophil, lauryl glucoside, and glycerides (PLGG) inhibits bacterial growth and has mucoadhesive properties. This study examined the efficacy of the device in women with RBV. This post-market clinical follow-up study comprised two phases. The first phase was an interventional, open-label, non-controlled, multicenter study enrolling 56 women. The second phase was an observational 10-month follow-up without treatment. After three cycles of PLGG treatment, recurrence was identified in 8 of 54 evaluable patients (14.81%). A positive effect on lactobacilli in the vaginal secretions was observed in 26 of 39 patients (66.67%). Among 35 patients observed after stopping PLGG treatment, one case of RBV (2.86%) was observed after 4 months, and an additional six cases (17.14%) were observed after 10 ± 2 months. Therefore, no recurrence was evidenced in 12 subjects (34.28%) at the end of the study. The use of PLGG vaginal ovules in the treatment of BV reduces the rate of recurrence and apparently produces a positive effect on the vaginal microbiota.

Long Term Rejuvenation of Facial Skin by Transplantation of Autologous Stromal Vascular Fraction and Pre-conditioned Matrix: A Clinical Study

Background: For skin rejuvenation, today no procedure describes a specific treatment of the extracellular matrix (ECM) combined with stromal vascular fraction (SVF) from adipose tissue. A new product AmeaCell® , allows SVF extraction and ECM preconditioning in hypoxic conditions. Hypoxia significantly increased the adhesion of adipose derived stem cells and enhace their proliferation and differentiation. Objective: This clinical study aimed to evaluate safety and efficiency of this new procedure, over one year. Material and methods: The study was performed on 23 patients. After a liposuction and fat proceed, SVF and the matrix were extracted and preconditioned following Ameacell® procedure, then injected into wrinkles. Results were scored for WSRS and GAIS scales at 6, 12 months after surgery. Results: No serious adverse reactions occurred. Regarding efficiency, whatever the baseline, the Ameacell® procedure triggered an improvement of WSRS score in most patients after one year follow-up: 75% of patients when WSRS score at baseline 2; 83% of patients when WSRS score at baseline 3. This is in accordance with the GAIS scored by both investigators and patients. Conclusion: This one-year follow-up clinical study using Ameacell® procedure, exhibited an improvement of facial skin appearance.

Pulmonary vascular disease in Veterans with post-deployment respiratory syndrome

Exertional dyspnea has been documented in US military personnel after deployment to Iraq and Afghanistan. We studied whether continued exertional dyspnea in this patient population is associated with pulmonary vascular disease (PVD). We performed detailed histomorphometry of pulmonary vasculature in 52 Veterans with biopsy-proven post-deployment respiratory syndrome (PDRS) and then recruited five of these same Veterans with continued exertional dyspnea to undergo a follow-up clinical evaluation, including symptom questionnaire, pulmonary function testing, surface echocardiography, and right heart catheterization (RHC). Morphometric evaluation of pulmonary arteries showed significantly increased intima and media thicknesses, along with collagen deposition (fibrosis), in Veterans with PDRS compared to non-diseased (ND) controls. In addition, pulmonary veins in PDRS showed increased intima and adventitia thicknesses with prominent collagen deposition compared to controls. Of the five Veterans involved in our clinical follow-up study, three had borderline or overt right ventricle (RV) enlargement by echocardiography and evidence of pulmonary hypertension (PH) on RHC. Together, our studies suggest that PVD with predominant venular fibrosis is common in PDRS and development of PH may explain exertional dyspnea and exercise limitation in some Veterans with PDRS.