scholarly journals Concentrated Bone Marrow Aspirate Injection for Hallux Sesamoid Disorders

2019 ◽  
Vol 4 (4) ◽  
pp. 2473011419S0039
Author(s):  
Yoshiharu Shimozono ◽  
Dexter Seow ◽  
John G. Kennedy
Keyword(s):  
Quality Of Life ◽  
Bone Marrow ◽  
Bone Marrow Aspirate ◽  
Shockwave Therapy ◽  
Vas Score ◽  
Concentrated Bone Marrow ◽  
The Mean

Category: Midfoot/Forefoot, Sports Introduction/Purpose: Sesamoidectomy is the most common surgical procedure for the treatment of hallux sesamoid pathology, including fracture, acute separation of bipartite sesamoid, sesamoiditis, and avascular necrosis (AVN). However, there is a concern of complications following sesamoidectomy, such as the development of hallux valgus/varus and transfer metatarsalgia due to the altered mechanical loading on the forefoot. Recent systematic review showed high complication rate of 22.5% following sesamoidectomy, prompting surgeons to find alternative methods. Concentrated bone marrow aspirate (CBMA) may have the potential to treat sesamoid disorders with avoidance of sesamoid resection. However, there is no studies investigating the effect of CBMA for sesamoid disorders. The purpose of this study was to evaluate the functional outcomes following the use of CBMA for hallux sesamoid disorders. Methods: A retrospective cohort study investigating consecutive patients treated with CBMA injection for the treatment of sesamoid disorders were performed. The sesamoid disorders included sesamoiditis, symptomatic bipartite or chronic nonunited sesamoid and AVN. The CBMA injection was indicated for patients with failed a minimum of 3 months non-surgical management including activity limitation, customized orthotics, physiotherapy and extracorporeal shockwave therapy. Clinical outcomes were evaluated using the Foot and Ankle Outcome Scores (FAOS), Short-Form 12 (SF-12), and visual analog scale (VAS) scores preoperatively and at final follow-up. Results: Total of 13 feet were included. The mean age was 26.9 years and mean follow-up time was 19.1 months. Patient demographic is shown in Table 1. Mean symptoms, pain, daily activities, sports activities and quality of life scores in FAOS significantly improved from 63.9, 55.4, 68.4, 37.3, and 30.9 preinjection to 91.2, 84.1 92.9, 72.7, and 64.8 postinjection, respectively at final follow-up (p<0.001). The mean SF-12 and VAS score significantly improved (34.3 to 62.5, 5.7 to 1.5, respectively, p<0.001). Of 9 patients played sports at preinjection, 7 patients returned to play at previous level. Two patients failed the treatment. One had second-CBMA injection and final VAS score was 1.0. Another one required subsequent shockwave-therapy followed by platelet-rich plasma injection with final VAS score of 1.5. Conclusion: No complications and adverse effects were reported in this cohort. In addition, no patients had any signs of progression or new emerge of AVN on plain radiographs. The current study demonstrates that CBMA injection is a safe and effective treatment for hallux sesamoid disorders when conservative treatment fails, with avoidance of sesamoid resection. CBMA injection can be a valid alternative for the treatment of sesamoid disorders, as it permits preservation of the biomechanical stability provided by the sesamoids which is an element inevitably vital for long-term quality of life. Further studies investigating long-term effects of this treatment should be warranted.

scholarly journals Outcomes Following Treatment of Talar Osteochondral Lesions with a Mixture of Particulate Allogenic Cartilage Extracellular Matrix and Bone Marrow Aspirate Concentrate: A Case Control Series

2019 ◽  
Vol 7 (7_suppl5) ◽  
pp. 2325967119S0032
Author(s):  
Mark C. Drakos ◽  
Taylor Nicole Cabe ◽  
Carolyn Sofka ◽  
Peter D. Fabricant ◽  
Jonathan T. Deland
Keyword(s):  
Bone Marrow ◽  
Extracellular Matrix ◽  
Bone Marrow Aspirate ◽  
Case Control ◽  
Osteochondral Lesions ◽  
Treatment Groups ◽  
Cartilage Extracellular Matrix

Objectives: There continues to be a general lack of consensus regarding the optimal treatment for osteochondral lesions of the talus (OLTs). Microfracture, once considered the gold-standard, has been associated with poor long-term results due to the formation of biomechanically inferior reparative fibrocartilage as opposed to hyaline cartilage. Particulate allogenic cartilage extracellular matrix offers a promising solution as an adjuvant therapy; however, there is currently minimal objective evidence to indicate its effect on post-operative outcomes. This study compares post-operative radiographic and clinical outcomes following treatment of OLTs with an adjuvant mixture of particulate cartilage extracellular matrix and bone marrow aspirate concentrate (BMAC) against outcomes following microfracture with or without BMAC. Methods: Patients diagnosed with an OLT and treated by a fellowship-trained orthopedic surgeon were screened for inclusion. Those whose surgical intervention included microfracture, microfracture augmented with BMAC alone, or microfracture augmented with a mixture of BMAC and particulate allogenic cartilage extracellular matrix were eligible for this case-control study. Lesion size, location, and concurrent injuries were recorded following retrospective chart review. Foot and Ankle Outcome Scores (FAOS) were collected pre-operatively and at a minimum of 1 year post-operatively through the prospective Registry database at the authors’ institution. Modified magnetic resonance observation of cartilage repair tissue (MOCART) scoring evaluated the structural quality of repaired lesions on MRIs collected greater than six months post-operatively. Differences in post-operative MOCART and FAOS scores were evaluated using ANOVA tests. Results: Forty-seven patients treated with microfracture alone, forty-seven treated with microfracture augmented by BMAC, and fifty-two treated with an adjuvant mixture of particulate allogenic cartilage extracellular matrix and BMAC were identified at a minimum of 2 years post-operatively. Average MOCART scores were significantly different between treatment groups (p=0.03). At an average follow-up of 10.86 months, patients who received adjunctive therapy had an average MOCART score of 73.5 ± 11.13. At an average follow-up of 23.06 months and 43.6 months respectively, patients treated with microfracture and BMAC and microfracture alone scored 63.33 ± 22.23 and 55 ± 23.92. There was no detectable statistically significant difference in post-operative FAOS scores between treatment groups. With respect to revision surgery, two patients (3.84%) originally treated with adjuvant particulate cartilage extracellular matrix and BMAC have required a secondary surgery as opposed to nine patients (9.57%) treated with microfracture and BMAC or microfracture alone. Conclusion: Increases in post-operative FAOS scores compared to pre-operative FAOS scores for all treatment groups indicate patients’ function and symptoms improved regardless of intervention received. However, significantly higher MOCART scores for the particulate cartilage extracellular matrix and BMAC treatment group suggest adjuvant treatment may help achieve better post-operative fill and structural integrity. Thus, long-term outcomes and the quality of reparative tissues may be improved through use of adjuvant treatments such as particulate allogenic cartilage extracellular matrix and BMAC.

Long-term outcomes and prognostic factors in pediatric patients with severe traumatic brain injury and elevated intracranial pressure

2008 ◽  
Vol 2 (4) ◽  
pp. 240-249 ◽  
Author(s):  
Jay Jagannathan ◽  
David O. Okonkwo ◽  
Hian Kwang Yeoh ◽  
Aaron S. Dumont ◽  
Dwight Saulle ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Intracranial Pressure ◽  
Pediatric Patients ◽  
Elevated Intracranial Pressure ◽  
The Mean

Object The management strategies and outcomes in pediatric patients with elevated intracranial pressure (ICP) following severe traumatic brain injury (TBI) are examined in this study. Methods This study was a retrospective review of a prospectively acquired pediatric trauma database. More than 750 pediatric patients with brain injury were seen over a 10-year period. Records were retrospectively reviewed to determine interventions for correcting ICP, and surviving patients were contacted prospectively to determine functional status and quality of life. Only patients with 2 years of follow-up were included in the study. Results Ninety-six pediatric patients (age range 3–18 years) were identified with a Glasgow Coma Scale score < 8 and elevated ICP > 20 mm Hg on presentation. The mean injury severity score was 65 (range 30–100). All patients were treated using a standardized head injury protocol. The mean time course until peak ICP was 69 hours postinjury (range 2–196 hours). Intracranial pressure control was achieved in 82 patients (85%). Methods employed to achieve ICP control included maximal medical therapy (sedation, hyperosmolar therapy, and paralysis) in 34 patients (35%), ventriculostomy in 23 patients (24%), and surgery in 39 patients (41%). Fourteen patients (15%) had refractory ICP despite all interventions, and all of these patients died. Seventy-two patients (75%) were discharged from the hospital, whereas 24 (25%) died during hospitalization. Univariate and multivariate analysis revealed that the presence of vascular injury, refractory ICP, and cisternal effacement at presentation had the highest correlation with subsequent death (p < 0.05). Mean follow-up was 53 months (range 11–126 months). Three patients died during the follow-up period (2 due to infections and 1 committed suicide). The mean 2-year Glasgow Outcome Scale score was 4 (median 4, range 1–5). The mean patient competency rating at follow-up was 4.13 out of 5 (median 4.5, range 1–4.8). Univariate analysis revealed that the extent of intracranial and systemic injuries had the highest correlation with long-term quality of life (p < 0.05). Conclusions Controlling elevated ICP is an important factor in patient survival following severe pediatric TBI. The modality used for ICP control appears to be less important. Long-term follow-up is essential to determine neurocognitive sequelae associated with TBI.

EXTENDED FOLLOW-UP IN 212 LONG-TERM ALLOGENEIC BONE MARROW TRANSPLANT SURVIVORS ISSUES OF QUALITY OF LIFE

1993 ◽  
Vol 55 (3) ◽  
pp. 551-556 ◽  
Author(s):  
GERHARD M. SCHMIDT ◽  
JOYCE C. NILAND ◽  
STEPHEN J. FORMAN ◽  
FILAR P. FONBUENA ◽  
ANDREW C. DAGIS ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Bone Marrow ◽  
Bone Marrow Transplant ◽  
Marrow Transplant ◽  
Allogeneic Bone Marrow ◽  
Allogeneic Bone ◽  
Allogeneic Bone Marrow Transplant

scholarly journals Results of Arthroscopic Talar Osteochondral Lesions with Bone Marrow Stimulation and BST-CarGel

2019 ◽  
Vol 4 (4) ◽  
pp. 2473011419S0016
Author(s):  
Jagwinder Dhaliwal ◽  
Andrew Wines
Keyword(s):  
Quality Of Life ◽  
Bone Marrow ◽  
Functional Outcome ◽  
Osteochondral Lesions ◽  
Foot And Ankle ◽  
Bone Marrow Stimulation ◽  
Marrow Stimulation ◽  
The Mean

Category: Ankle, Trauma Introduction/Purpose: Osteochondral lesions (OCL) are described as any defect involving both the articular surface and the subchondral bone of the talus. They are commonly associated with acute ankle injuries occurring often in active population. Bone marrow stimulation with microfracture is a standard reparative treatment for OCD however decline in related functional outcome has been reported. BST-CarGel contains chitosan which binds to negatively charged cartilage surface acting as biocompatible scaffold. This allows repair tissue with significant filling volume and proper integration into the surroundings. There has been reported better quantitative and qualitative cartilage repair tissue at 12 months with BST-CarGel. We first report on clinical results of bone marrow stimulation and BST-Cargel for recalcitrant talar OCL in patients previously treated with microfracture alone in a prospective study. Methods: This prospective single surgeon series was limited to patients with symptomatic OCL who previously had arthroscopic debridement and microfracture for same lesion. The pre-operative evaluation of all patients involved clinical assessment, weight bearing plain radiographs and magnetic resonance imaging of ankle joint. Inclusion criteria were age 18-55 years, single focal OCL of talus less than 3 cm2 and previous microfracture. Exclusion criteria was evidence of ankle osteoarthritis and allergy to chitosan or known hypersensitivity to crustaceans such as shrimp, lobster, and crab. Functional outcome assessment was measured using Foot and Ankle outcome score (FAOS) and EQ5D (Health related quality of life) pre and post-operatively. We used paired Student’s t-test for statistical analysis. Values for p < 0.05 were regarded as significant. The surgical technique used have been previously described in literature for OCL of the talus treated with bone marrow stimulation and Cargel. Results: There were fourteen patients who were treated with arthroscopic BST-Cargel with BMS and followed up prospectively. There was no loss to follow-up. The mean follow-up post-operatively was 28 months. There were eight males and six females in the study group. Patient mean age at the time of operation was 42 years (21–60 years). The mean size of talar OCL treated was 2.8 cm2 . Mean FAOS score for symptoms pre-operatively was 41.7 and post-operative was 52.8 (P<0.01). Mean FAOS pain subscale pre-operatively was 45.7 and post-operatively 55.6 (P<0.01). FAOS function and daily living score pre-operatively was 41.4 and post-operatively was 55.8 (P<0.01). Mean FAOS quality of life score was 39.2 pre-operatively and post-operative score 57.2 (P<0.01). EQ5D pre-operatively was 15 and post-operatively was 8 (P<0.01). Conclusion: We noted statistically significant improvement in each subscale of The Foot and Ankle Outcome questionnaire scores post-operatively. There was also significant improvement in generic health status instrument EQ-5D. We also noted talar OCL improvement on MRI scan taken pre and post BST-CarGel treatment. Recalcitrant OCL of talus present considerable challenge with persistent pain, functional limitations and secondary osteoarthritis. BST-Cargel treatment in our clinical study improved functional outcome scores similar to previously reported hip and knee studies. It requires standard arthroscopic technique and no complications were observed in our study.

Chronic pain in multiple sclerosis: A10-year longitudinal study

2017 ◽  
Vol 16 (1) ◽  
pp. 198-203 ◽  
Author(s):  
Jamie Young ◽  
Bhasker Amatya ◽  
Mary P. Galea ◽  
Fary Khan
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Chronic Pain ◽  
Longitudinal Study ◽  
The Mean ◽  
The Impact ◽  
Over Time

AbstractBackground and purposePain is a common symptom associated with multiple sclerosis (MS), and has lasting effects on an individual’s functional capacity and quality of life. A wide range of prevalence rates of pain (between 23% and 90%)have been reported in MS and this is mainly due to the methodological differences amongst the studies such as variability in patient sources, method of sampling and the definition of pain used. Chronic pain in MS, defined as pain lasting for greater than 3–6 months, can have a significant impact on their biopsychosocial health, including negative impact on activities of daily living, relationships and social participation. The long-term course of MS-related pain and its impact in an Australian cohort over a 7-year period has been investigated earlier. The aim of this longitudinal study was to describe the impact of chronic pain, pain-related disability and carer burden in persons with MS over a 10-year period. The aim of this longitudinal study was to describe the impact of chronic pain, pain-related disability and carer burden in persons with MS over a 10-year period.MethodsThis was a prospective longitudinal study conducted at the Rehabilitation Department of Royal Melbourne Hospital (RMH), a tertiary referral hospital in Victoria and Australia. The source of participants was from the RMH MS database and contains detailed MS patient information including demographic data, diagnosis details (using McDonald’s criteria), pain characteristics. Structured face-face interviews and validated measures were used, which include the visual analogue scale (VAS); chronic pain grade (CPG); the assessment of quality of life (AQoL) and the carer strain index (CSI). The mean age of the participants (n = 70) was 55.3 years and majority (70%) were female.ResultsThe mean age of the participants (n = 70) was 55.3 years and majority (70%) were female. The findings show that over time (10 years), participants report having greater bilateral bodily pain and greater description of pain as ‘worse as it could be’. Pain types were similar to 7-years follow-up but remained higher than baseline. There was a significant deterioration in quality of life in those with more severe CPG over time. Almost half of the participants 31 (44%) required care either from a private carer, institution or from a family member. Although fear of taking medications and side effects were common barriers to treatment for pain, there was an increase in the use of pharmacological treatment over time and an increase in the use of healthcare services, mainly neurologists and general practitioners.ConclusionsThe pain measures reported by the participants were similar to those at the 7-year follow-up except there was a greater representation of bilateral pain locations (limb, trunk and facial pain) compared to baseline and 7-year follow-up. At 10-year follow-up, more participants used medications compared tc 7-year follow-up and there was an increase in the use of health professionals at the 10-year follow-up At the 10-year follow up QoL of the participants deteriorated significantly and more participants had progressed to higher CPGIII and CPGIV. This study demonstrates that chronic pain is a significant issue over time in MS, with clinical and health implications, impact on quality of life, disability and healthcare utilization.ImplicationsGreater awareness of chronic pain in pwMS, cognitive classifications and an interdisciplinary approach is required to improve long-term patient outcomes and well-being.Crown Copyright © 2017 Published by Elsevier B.V. on behalf of Scandinavian Association for the Study of Pain. All rights reserved.

scholarly journals Five-Year Results of a Prospective Multicenter Trial: AdVance XP for Postprostatectomy-Incontinence in Patients with Favorable Prognostic Factors

2021 ◽  
pp. 1-7
Author(s):  
Jan-Niclas Mumm ◽  
Benedikt Klehr ◽  
Severin Rodler ◽  
Alexander Kretschmer ◽  
Theresa Vilsmaier ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multicenter Trial ◽  
Complication Rates ◽  
Night Time ◽  
Vas Score ◽  
International Consultation ◽  
Urine Loss

<b><i>Objective:</i></b> The aim of this study was to assess the security, value, and efficacy of the second-generation AdVance male sling XP (Boston Scientific®), after implementation in 2010 with advantageous modifications in the sling structure and needle shape, in a prospective multicenter long-term follow-up study. <b><i>Methods:</i></b> In total, 115 patients were included. Exclusion criteria were earlier incontinence (UI) surgery, nocturnal UI, former radiotherapy, or night-time incontinence. We also excluded patients with a functional urethra &#x3c;1 cm in a preoperatively performed repositioning test. A consistent 24-h pad test, International Quality of Life (IQOL) score, visual analog pain scale (VAS), International Consultation-Incontinence Questionnaire (ICIQ-UI SF), International Index of Erectile Function (IIEF-5), International Prostate Symptom Score (IPSS), and Patient Global Impression of Improvement (PGI-I) scores were requested postoperatively. <b><i>Results:</i></b> The 24-month follow-up (114 patients) revealed 64.0% cured and 28.8% improved patients. Mean urine loss was reduced significantly to 19.0 g (<i>p</i> &#x3c; 0.001). A mean PGI score of 1.5 and a mean VAS score of 0.2 were obtained. The 60-month follow-up (59 patients) revealed 57.6% cured and 25.4% improved patients. Mean urine loss was reduced significantly to 18.3 g (<i>p</i> &#x3c; 0.001). A mean PGI score of 1.6 and a mean VAS score of 0.2 were obtained. <b><i>Conclusions:</i></b> The AdVance XP displays excellent continence results and secure effectiveness over a 5-year period. Moreover, these data are demonstrating low complication rates and improved quality of life in the long-term use of AdVance XP.

scholarly journals A five-year follow-up observational study of the T-14 paediatric throat disorders outcome measure in tonsillectomy and adenotonsillectomy

2019 ◽  
Vol 101 (1) ◽  
pp. 40-43
Author(s):  
KM Konieczny ◽  
TN Pitts-Tucker ◽  
TC Biggs ◽  
MB Pringle
Keyword(s):  
Quality Of Life ◽  
Observational Study ◽  
Outcome Measurement ◽  
Paediatric Population ◽  
Measurement Tool ◽  
Postoperative Time ◽  
The Mean

Introduction The T-14 questionnaire is a validated outcome measurement tool to assess the value of paediatric tonsillectomy from a parent’s perspective. There is a paucity of data regarding the long-term postoperative effects of tonsillectomy on quality of life in the paediatric population. Our previous study assessed T-14 scores up to year 2 postoperatively, with this study extending follow-up to 5 years. Materials and methods We undertook a prospective uncontrolled observational study examining 54 paediatric patients undergoing tonsillectomy at Portsmouth Hospitals NHS Trust. Parents of children undergoing surgery were invited to complete a T-14 questionnaire preoperatively, as well as at 3 months, 6 months, 1 year, 2 years and now 5 years postoperatively. Results In total, 44 of 54 patients completed questionnaires preoperatively and at all postoperative time points, with 46 being completed at 5 years. There was a highly significant (P < 0.001) difference between the preoperative scores and all other measured T-14 scores postoperatively. The mean score preoperatively was 33.3 compared with 1.0 at 5 years. Conclusions This is the first study to assess long-term quality of life following paediatric tonsillectomy using the T-14 questionnaire. The benefits of tonsillectomy on long-term quality of life further confirms its value within the paediatric population.

scholarly journals Dynamic assessment of quality of life after autologous bone marrow transplantation

Blood ◽  
1992 ◽  
Vol 80 (3) ◽  
pp. 825-830 ◽  
Author(s):  
NJ Chao ◽  
DK Tierney ◽  
JR Bloom ◽  
GD Long ◽  
TA Barr ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Bone Marrow ◽  
Bone Marrow Transplantation ◽  
Autologous Bone Marrow Transplantation ◽  
Autologous Bone Marrow ◽  
First Year ◽  
The Mean ◽  
Autologous Bone

To determine the quality of life in adult patients after autologous bone marrow transplantation (BMT), we administered a questionnaire to a cohort of patients seen at a single referral-based center. The sample included adults 18 years and older during the 1 year following an autologous BMT. Both disease-free patients and those who relapsed with 1-year of follow-up data available were included. Of 59 eligible patients, 58 (98%) responded to the questionnaire. Patients completed a telephone questionnaire administered by a nurse specialist in the field of BMT approximately every 90 days. At the time of initial contact on day +90, the mean quality of life was 7.8 (range, 1 to 10) on a scale of 1 to 10, with 10 being the best. By the end of the first year of follow-up, the mean quality of life was 8.9 (range, 3 to 10). Seventy- eight percent of the patients were employed. Twenty-one percent lost weight during the first year, with the majority reporting voluntary weight loss. Fourteen percent reported difficulties with sexual activity. Only 5% reported difficulty with sleeping or with frequent colds. One patient felt that her appearance was worse, and none of the patients reported a poor appetite. Eighty-eight percent of surviving adult patients reported an above-average to excellent quality of life 1 year following autologous BMT. This outcome is encouraging and suggests that this procedure is not associated with long-term morbidity in the surviving adult patient.

scholarly journals Normal Quality of Life after the Cox-Maze Procedure for Atrial Fibrillation

2008 ◽  
Vol 3 (3) ◽  
pp. 142-146 ◽  
Author(s):  
Spencer J. Melby ◽  
Andreas Zierer ◽  
Jordon G. Lubahn ◽  
Marci S. Bailey ◽  
James L. Cox ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Atrial Fibrillation ◽  
Short Form ◽  
Maze Procedure ◽  
Medical Outcomes ◽  
Health Domains ◽  
The Mean

Objective Atrial fibrillation (AF) has been shown in numerous studies to significantly decrease patient's quality of life. The Cox-Maze procedure has excellent long-term efficacy in curing AF. However, it is unknown whether this procedure improves long-term quality of life in these patients. The purpose of this study was to examine late quality of life in patients who underwent a lone Cox-Maze procedure. Methods Between 1987 and 2003, 163 patients underwent a Cox-Maze procedure for lone AF at our institution. Of these, 68 patients agreed and completed the Medical Outcomes Study Short Form 36 Health Survey. Scores from the age-matched general U.S. population were normalized to a mean of 50 and standard deviation of 10 to facilitate comparison. Collected data were compared with the norm-based score for each domain using a one-sample t test. Four patients were removed from the analysis because of AF recurrence. Results There were 52 males (81%). Mean age was 52.6 ± 9.5 years. Preoperatively, 37 patients (58%) had paroxysmal and 25 patients (39%) had persistent or permanent AF. The mean duration of AF before surgery was 9.8 ± 8.2 years. There was no statistical difference in norm-based scores between the Cox-Maze procedure group and the age-matched general U.S. population in any of the eight health domains at a mean follow-up of 8.7 ± 3.7 years. Conclusion Our results suggest that the Cox-Maze procedure cures AF in the majority of patients, and that those patients who are cured had a normal quality of life when compared with the general population at late follow-up.

scholarly journals The Effects of Granulocyte Colony-Stimulating Factor in Patients with a Large Anterior Wall Acute Myocardial Infarction to Prevent Left Ventricular Remodeling: A 10-Year Follow-Up of the RIGENERA Study

2020 ◽  
Vol 9 (4) ◽  
pp. 1214
Author(s):  
Antonio Maria Leone ◽  
Domenico D’Amario ◽  
Francesco Cannata ◽  
Francesca Graziani ◽  
Josip A. Borovac ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Left Ventricular ◽  
Lv Remodeling ◽  
The Mean ◽  
Stimulating Factor

Background: the RIGENERA trial assessed the efficacy of granulocyte-colony stimulating factor (G-CSF) in the improvement of clinical outcomes in patients with severe acute myocardial infarction. However, there is no evidence available regarding the long-term safety and efficacy of this treatment. Methods: in order to evaluate the long-term effects on the incidence of major adverse events, on the symptom burden, on the quality of life and the mean life expectancy and on the left ventricular (LV) function, we performed a clinical and echocardiographic evaluation together with an assessment using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and the Seattle Heart Failure Model (SHFM) at 10-years follow-up, in the patients cohorts enrolled in the RIGENERA trial. Results: thirty-two patients were eligible for the prospective clinical and echocardiography analyses. A significant reduction in adverse LV remodeling was observed in G-CSF group compared to controls, 9% vs. 48% (p = 0.030). The New York Heart Association (NYHA) functional class was lower in G-CSF group vs. controls (p = 0.040), with lower burden of symptoms and higher quality of life (p = 0.049). The mean life expectancy was significantly higher in G-CSF group compared to controls (15 ± 4 years vs. 12 ± 4 years, p = 0.046. No difference was found in the incidence of major adverse events. Conclusions: this longest available follow-up on G-CSF treatment in patients with severe acute myocardial infarction (AMI) showed that this treatment was safe and associated with a reduction of adverse LV remodeling and higher quality of life, in comparison with standard-of-care treatment.

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