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1.
Injury ; 54(3): 871-879, 2023 Mar.
Article in English | MEDLINE | ID: mdl-36642567

ABSTRACT

INTRODUCTION: Mortality due to trauma has reduced the past decades. Trauma network implementations have been an important contributor to this achievement. Besides mortality, patient reported outcome parameters should be included in evaluation of trauma care. While concentrating major trauma care, hospitals are designated with a certain level of trauma care following specific criteria. OBJECTIVE: Comparing health status of major trauma patients after two years across different levels of trauma care in trauma networks. METHODS: Multicentre observational study comprising a secondary longitudinal multilevel analysis on prospective cohorts from two neighbouring trauma regions in the Netherlands. INCLUSION CRITERIA: patient aged ≥ 18 with an ISS > 15 surviving their injuries at least one year after trauma. Health status was measured one and two years after trauma by EQ-5D-5 L, added with a sixth health dimension on cognition. Level I trauma centres were considered as reference in uni- and multivariate analysis. RESULTS: Respondents admitted to a level I trauma centre scored less favourable EQ-US and EQ-VAS in both years (0.81-0.81, 71-75) than respondents admitted to a level II (0.88-0.87, 78-85) or level III (0.89-0.88, 75-80) facility. Level II facilities scored significantly higher EQ-US and EQ-VAS in time for univariate analysis (ß 0.095, 95% CI 0.038-0.153, p = 0.001, and ß 7.887, 95% CI 3.035-12.740, p = 0.002), not in multivariate analysis (ß 0.052, 95% CI -0.010-0.115, p = 0.102, and ß 3.714, 95% CI -1.893-9.321, p = 0.193). Fewer limitations in mobility (OR 0.344, 95% CI 0.156-0.760), self-care (OR 0.219, 95% CI 0.077-0.618), and pain and discomfort (OR 0.421, 95% CI 0.214-0.831) remained significant for level II facilities in multivariate analysis, whereas significant differences with level III facilities disappeared. CONCLUSION: Major trauma patients admitted to level I trauma centres reported a less favourable general health status and more limitations compared to level II and III facilities scoring populations norms one to two years after trauma. Differences on general health status and limitations in specific health domains disappeared in adjusted analysis. Well-coordinated trauma networks offer homogeneous results for all major trauma patients when they are distributed in different centres according to their need of care.


Subject(s)
Emergency Medical Services , Quality of Life , Humans , Prospective Studies , Health Status , Netherlands , Surveys and Questionnaires
2.
J Orthop Surg Res ; 16(1): 722, 2021 Dec 20.
Article in English | MEDLINE | ID: mdl-34930350

ABSTRACT

BACKGROUND: This study evaluates whether a circumferential cast compared to a plaster splint leads to less fracture redisplacement in reduced extra-articular distal radius fractures (DRFs). METHODS: This retrospective multicentre study was performed in four hospitals (two teaching hospitals and two academic hospitals). Adult patients with a displaced extra-articular DRF, treated with closed reduction, were included. Patients were included from a 5-year period (January 2012-January 2017). According to the hospital protocol, fractures were immobilized with a below elbow circumferential cast (CC) or a plaster splint (PS). The primary outcome concerned the difference in the occurrence of fracture redisplacement at one-week follow-up. RESULTS: A total of 500 patients were included in this study (PS n = 184, CC n = 316). At one-week follow-up, fracture redisplacement occurred in 52 patients (17%) treated with a CC compared to 53 patients (29%) treated with a PS. This difference was statistically significant (p = 0.001). CONCLUSION: This study suggests that treatment of reduced DRFs with a circumferential cast might cause less fracture redisplacement at 1-week follow-up compared to treatment with a plaster splint. Level of Evidence Level III, Retrospective study.


Subject(s)
Casts, Surgical , Fracture Dislocation/surgery , Fracture Fixation, Internal/methods , Fracture Fixation/methods , Radius Fractures/surgery , Splints , Adult , Casts, Surgical/adverse effects , Fracture Fixation/adverse effects , Humans , Radius Fractures/diagnostic imaging , Retrospective Studies
3.
PLoS One ; 15(6): e0233690, 2020.
Article in English | MEDLINE | ID: mdl-32525901

ABSTRACT

INTRODUCTION: Pelvic fractures can have long-term consequences for health-related quality of life (HRQoL). The main purpose of this study is to provide insight into short-term HRQoL in the first year after pelvic injury and to identify short-term prognostic factors of decreased outcome. METHODS: This is a prospective, observational, multicenter, follow-up cohort study in which HRQoL and functional outcomes were assessed during 12-month follow-up of injured adult patients admitted to 1 of 10 hospitals in the county of Noord-Brabant, the Netherlands. The data were collected by self-reported questionnaires at 1 week (including preinjury assessment) and 1, 3, 6 and 12 months after injury. The EuroQoL-5D (EQ-5D), visual analog scale (VAS), Merle d'Aubigné Hip Score (MAHS) and Majeed Pelvic Score (MPS) were used. Multivariable mixed models were used to examine the course of the HRQoL and the prognostic factors for decreased HRQoL and functional outcomes over time. RESULTS: A total of 184 patients with pelvic fractures were identified between September 2015-September 2016; the fractures included 71 Tile A, 44 Tile B and 10 Tile C fractures and 59 acetabular fractures. At the pre-injury, 1 week, and 1, 3, 6 and 12 months after injury time points, the mean EQ-5D Index values were 0.90, 0.26, 0.45, 0.66, 0.77 and 0.80, respectively, and the mean EQ-VAS values were 83, 45, 57, 69, 75 and 75, respectively. At 6 and 12 months after injury, 22 and 25% of the MPS < 65 year group, 38 and 47% of the MPS ≥ 65 year group and 34 and 51% of the MAHS group, respectively, reached the maximum score. Pre-injury score, female gender and high Injury Severity Score (ISS) were important prognostic factors for a decreased HRQoL, and the EQ-5D VAS ß = 0.43 (95% CI: 0.31 - 0.57), -6.66 (95% CI: -10.90 - -0.43) and -7.09 (95% CI: -6.11 - -5.67), respectively. DISCUSSION: Patients with pelvic fractures experience a reduction in their HRQoL. Most patients do not achieve the HRQoL of their pre-injury state within 1 year after trauma. Prognostic factors for decreased HRQoL are a low pre-injury score, high ISS and female gender. We do not recommend using the MAHS and MPS in mid- or long-term follow-up of pelvic fractures because of ceiling effects. Trial registration number NCT02508675.


Subject(s)
Fractures, Bone/complications , Injury Severity Score , Pelvic Bones/injuries , Quality of Life , Adult , Aged , Female , Follow-Up Studies , Fractures, Bone/diagnosis , Fractures, Bone/psychology , Humans , Male , Middle Aged , Netherlands , Prognosis , Prospective Studies , Registries/statistics & numerical data , Self Report/statistics & numerical data , Sex Factors , Visual Analog Scale
4.
Injury ; 50(6): 1216-1222, 2019 Jun.
Article in English | MEDLINE | ID: mdl-31029370

ABSTRACT

AIMS: This study was conducted to determine long-term (5-10 years) health-related quality of life (HRQOL) and ceiling effects in patients with a pelvic ring fracture. PATIENTS AND METHODS: We identified all patients with pelvic ring fractures after high-energy trauma admitted at two level 1 trauma centres in the Netherlands from 2006 to 2011. Patients were asked to complete the Majeed Pelvic Score (MPS), EuroQol-5D (EQ-5D) and Short Musculoskeletal Function Assessment (SMFA) questionnaires. HRQOL analysis used a multiple linear regression model. RESULTS: In total, 136 patients returned the questionnaires. The median follow-up period was 8.7 years. The mean MPS and EQ-5D-VAS scores were 85.1 and 74, respectively. The mean EQ-5D index scores were 0.87, 0.81 and 0.82 in Tile B, A and C patients, respectively. The mean SMFA index was 24. A ceiling effect was observed for 1/3 of the patients. After multiple linear regression analysis, no differences were identified among the various fracture types for each questionnaire, with the exception of 2 subscales of the MPS. CONCLUSION: Patients who suffer pelvic ring fractures generally have good HRQOL outcomes after 5-10 years. No significant differences were found among different fracture types. Long-term follow-up of patients with Tile C fractures is warranted.


Subject(s)
Fracture Fixation/rehabilitation , Fracture Healing/physiology , Fractures, Bone/physiopathology , Pelvic Bones/injuries , Quality of Life/psychology , Trauma Centers , Adult , Aged , Cross-Sectional Studies , Female , Follow-Up Studies , Fracture Fixation/psychology , Fractures, Bone/epidemiology , Fractures, Bone/psychology , Humans , Linear Models , Male , Middle Aged , Netherlands/epidemiology , Patient Outcome Assessment , Young Adult
5.
Br J Surg ; 106(6): 701-710, 2019 05.
Article in English | MEDLINE | ID: mdl-30892692

ABSTRACT

BACKGROUND: Although mortality rates following major trauma are continuing to decline, a growing number of patients are experiencing long-term disability. The aim of this study was to identify factors associated with health status in the first year following trauma and develop prediction models based on a defined trauma population. METHODS: The Brabant Injury Outcome Surveillance (BIOS) study was a multicentre prospective observational cohort study. Adult patients with traumatic injury were included from August 2015 to November 2016 if admitted to one of the hospitals of the Noord-Brabant region in the Netherlands. Outcome measures were EuroQol Five Dimensions 5D-3L (EQ-5D™ utility and visual analogue scale (VAS)) and Health Utilities Index (HUI) 2 and 3 scores 1 week and 1, 3, 6 and 12 months after injury. Prediction models were developed using linear mixed models, with patient characteristics, preinjury health status, injury severity and frailty as possible predictors. Predictors that were significant (P < 0·050) for one of the outcome measures were included in all models. Performance was assessed using explained variance (R2 ). RESULTS: In total, 4883 patients participated in the BIOS study (50·0 per cent of the total), of whom 3366 completed the preinjury questionnaires. Preinjury health status and frailty were the strongest predictors of health status during follow-up. Age, sex, educational level, severe head or face injury, severe torso injury, injury severity, Functional Capacity Index score, co-morbidity and duration of hospital stay were also relevant in the multivariable models predicting health status. R2 ranged from 35 per cent for EQ-VAS to 48 per cent for HUI 3. CONCLUSION: The most important predictors of health status in the first year after trauma in this population appeared to be preinjury health status and frailty.


Subject(s)
Decision Support Techniques , Health Status Indicators , Health Status , Wounds and Injuries , Adult , Aged , Female , Follow-Up Studies , Frailty , Humans , Linear Models , Male , Middle Aged , Multivariate Analysis , Netherlands , Prognosis , Prospective Studies , Quality of Life , Recovery of Function , Wounds and Injuries/complications , Wounds and Injuries/diagnosis , Wounds and Injuries/physiopathology , Wounds and Injuries/psychology
6.
Injury ; 49(4): 812-818, 2018 Apr.
Article in English | MEDLINE | ID: mdl-29566985

ABSTRACT

BACKGROUND: Pelvic ring fractures might have consequences for health-related quality of life (HrQoL). The main purpose of this study was to evaluate patients' HrQoL after a pelvic ring fracture, considering the patients' characteristics. A cross-sectional study was conducted using the EuroQoL-5D (EQ-5D) and the Majeed pelvic score (MPS). METHODS: One hundred ninety-five patients (86%) with pelvic ring fractures who were conservatively or surgically treated in a level 1 trauma centre between 2011 and 2015 were included in this study (mean follow up: 29 months, range 6-61). A telephone survey of all patients was conducted. Multiple logistic and linear regression analyses were used for statistical assessment with the EQ-5D and the MPS. The MPS results were split into two age groups with a cut-off point of 65 years. RESULTS: EQ-5D: The mean EQ-5D Visual Analogue Scale (VAS) for Tiles A-C was, respectively, 74 (SD 18), 74 (SD 19) and 67 (SD 21), and the mean EQ-5D index score was, respectively, 0.81 (SD 0.23), 0.77 (SD 0.30) and 0.71 (SD 0.26). Compared with Tile A, patients in Tile C experienced significantly more pain (odds ratio 6.28 (1.73-22.82 95% CI), P < 0.01). Clinically relevant differences in EQ-5D scores between Tile A and Tile C were seen in the domains of usual activities and anxiety and in the index score. MPS: The mean MPS of Tiles A-C patients in the <65 group was, respectively, 86 (SD 15), 81 (SD 17), and 74 (SD 16), and in the ≥65 group, it was, respectively, 69 (SD 15), 68 (SD 15) and 66 (SD 9). In the <65 group, significant differences in MPS results between the Tile groups regarding pain (P < 0.01) and the total MPS score (P = 0.04) were seen. Neither significant regression coefficients nor clinically relevant differences were found in the ≥65 group. CONCLUSIONS: In conclusion, our study showed that pain was increased in patients with Tile C fractures, compared with Tiles A and B. Furthermore, Tile C patients had significantly lower EQ-5D index and total MPS scores. However, these problems were not seen in the ≥65 group.


Subject(s)
Fracture Fixation, Internal/rehabilitation , Fracture Healing/physiology , Fractures, Bone/rehabilitation , Pelvic Bones/injuries , Quality of Life , Aged , Biomechanical Phenomena , Cross-Sectional Studies , Female , Follow-Up Studies , Fracture Fixation, Internal/psychology , Fractures, Bone/physiopathology , Fractures, Bone/psychology , Fractures, Bone/surgery , Health Surveys , Humans , Male , Middle Aged , Pain Measurement , Treatment Outcome
7.
Injury ; 48(9): 1978-1984, 2017 Sep.
Article in English | MEDLINE | ID: mdl-28551050

ABSTRACT

PURPOSE: The purpose of this study was two-fold. The first goal was to investigate which variables were associated with the remaining physical limitations of severely injured patients after the initial rehabilitation phase. Second, we investigated whether physical limitations were attributable to the association between psychological complaints and quality of life in this patient group. METHODS: Patients who were 18 years or older and who had an injury severity score (ISS)>15 completed a set of questionnaires at one time-point after their rehabilitation phase (15-53 months after their trauma). The Short Musculoskeletal Function Assessment (SMFA) questionnaire was used to determine physical limitations. The Hospital Anxiety and Depression Scale, the Dutch Impact of Event Scale and the Cognitive Failure Questionnaire were used to determine psychological complaints, and the World Health Organization Quality of Life assessment instrument-BREF was used to measure general Quality of Life (QOL). Differences in physical limitations were investigated for several trauma- and patient-related variables using non-parametric independent-sample Mann-Whitney U tests. Multiple linear regression was performed to investigate whether the decreased QOL of severely injured patients with psychological complaints could be explained by their physical limitations. RESULTS: Older patients, patients with physical complaints before the injury, patients with higher ISS scores, and patients who had an injury of the spine or of the lower extremities reported significantly more physical problems. Additionally, patients with a low education level, patients who were living alone, and those who were unemployed reported significantly more long-term physical problems. Severely injured patients without psychological complaints reported significantly less physical limitations than those with psychological complaints. The SMFA factor of Lower extremity dysfunction was a confounder of the association between psychological complaints and QOL in all QOL domains. CONCLUSIONS: Long-term physical limitations were mainly reported by patients with psychological complaints. The decreased QOL of severely injured patients with psychological complaints can partially be explained by physical limitations, particularly those involving lower extremity function. Experienced physical limitations were significantly different for some trauma and patient characteristics. These characteristics may be used to select patients for whom a rehabilitation programme would be useful.


Subject(s)
Activities of Daily Living/psychology , Disabled Persons/psychology , Quality of Life , Wounds and Injuries/psychology , Adult , Cross-Sectional Studies , Female , Follow-Up Studies , Humans , Injury Severity Score , Male , Middle Aged , Netherlands/epidemiology , Outcome Assessment, Health Care , Sickness Impact Profile , Stress Disorders, Post-Traumatic/epidemiology , Surveys and Questionnaires , Wounds and Injuries/epidemiology , Wounds and Injuries/physiopathology , Young Adult
8.
Injury ; 48(3): 578-590, 2017 Mar.
Article in English | MEDLINE | ID: mdl-28077211

ABSTRACT

BACKGROUND: Over the past decades, the number of survivors of injuries has rapidly grown. It has become important to focus more on the determinants of non-fatal outcome. Although socio-economic status (SES) is considered to be a fundamental determinant of health in general, the role of SES as a determinant of non-fatal outcome after injury is largely unknown. METHODS: An online search was conducted in November 2015 using Embase, Medline, Web of Science, Cinahl, Cochrane, Google scholar and PubMed. Studies examining the relation between SES and a physical or psychological outcome measure, or using SES as a confounder in a general trauma population were included. There were no restrictions regarding study design. The 'Quality in Prognostic Studies tool' was used to assess the methodological quality of the included studies. RESULTS: The 24 included studies showed large variations in methodological quality. The number of participants ranged from 56 to 4639, and assessments of the measures ranged from immediately to 6year post-injury. Studies used a large number of variables as indicators of SES. Participant's educational level was used most frequently. The majority of the studies used a multivariable technique to analyse the relation between SES and non-fatal outcome after injury. All studies found a positive association (80% of studies significant, n=19) between increased SES and better non-fatal outcome after injury. CONCLUSION: Although an adequate and valid measure of SES is lacking, the results of this review showed that SES is an important determinant of non-fatal outcome after injury. Future research should focus on the definition and measurement of SES and should further underpin the effect of SES on non-fatal outcome after injury.


Subject(s)
Hospitalization/statistics & numerical data , Socioeconomic Factors , Wounds and Injuries/epidemiology , Health Surveys , Humans , Netherlands/epidemiology , Outcome Assessment, Health Care , Residence Characteristics , Wounds and Injuries/physiopathology
9.
Inj Prev ; 23(1): 59, 2017 02.
Article in English | MEDLINE | ID: mdl-27154507

ABSTRACT

INTRODUCTION: Trauma is a major public health problem worldwide that leads to high medical and societal costs. Overall, improved understanding of the full spectrum of the societal impact and burden of injury is needed. The main purpose of the Brabant Injury Outcome Surveillance (BIOS) study is to provide insight into prevalence, predictors and recovery patterns of short-term and long-term health-related quality of life (HRQoL) and costs after injury. MATERIALS AND METHODS: This is a prospective, observational, follow-up cohort study in which HRQoL, psychological, social and functional outcome, and costs after trauma will be assessed during 24 months follow-up within injured patients admitted in 1 of 10 hospitals in the county Noord-Brabant, the Netherlands. Data will be collected by self-reported questionnaires at 1 week (including preinjury assessment), and 1, 3, 6, 12 and 24 months after injury. If patients are not capable of filling out the questionnaires, proxies will be asked to participate. Also, information about mechanism and severity of injury, comorbidity and indirect and direct costs will be collected. Mixed models will be used to examine the course of HRQoL, functional and psychological outcome, costs over time and between different groups, and to identify predictors for poor or good outcome. RELEVANCE: This study should make a substantial contribution to the international collaborative effort to assess the societal impact and burden of injuries more accurately. The BIOS results will also be used to develop an outcome prediction model for outcome evaluation including, besides the classic fatal, non-fatal outcome. TRIAL REGISTRATION NUMBER: NCT02508675.


Subject(s)
Cost of Illness , Population Surveillance , Quality of Life/psychology , Wounds and Injuries/epidemiology , Disability Evaluation , Female , Humans , Male , Netherlands/epidemiology , Prevalence , Prospective Studies , Recovery of Function , Surveys and Questionnaires , Wounds and Injuries/economics , Wounds and Injuries/physiopathology , Wounds and Injuries/psychology
10.
Injury ; 45(5): 869-73, 2014 May.
Article in English | MEDLINE | ID: mdl-24472800

ABSTRACT

BACKGROUND: For optimal treatment of trauma patients it is of great importance to identify patients who are at risk for severe injuries. The Dutch field triage protocol for trauma patients, the LPA (National Protocol of Ambulance Services), is designed to get the right patient, in the right time, to the right hospital. Purpose of this study was to determine diagnostic accuracy and compliance of this triage protocol. STUDY DESIGN: Triage criteria were categorised into physiological condition (P), mechanism of trauma (M) and injury type (I). A retrospective analysis of prospectively collected data of all high-energy trauma patients from 2008 to 2011 in the region Central Netherlands is performed. Diagnostic parameters (sensitivity, specificity, negative predictive value, positive predictive value) of the field triage protocol for selecting severely injured patients were calculated including rates of under- and overtriage. Undertriage was defined as the proportion of severely injured patients (Injury Severity Score (ISS)≥16) who were transported to a level two or three trauma care centre. Overtriage was defined as the proportion of non-severely injured patients (ISS<16) who were transported to a level one trauma care centre. RESULTS: Overall sensitivity and specificity of the field triage protocol was 89.1% (95% confidence interval (CI) 84.4-92.6) and 60.5% (95% CI 57.9-63.1), respectively. The overall rate of undertriage was 10.9% (95%CI 7.4-15.7) and the overall rate of overtriage was 39.5% (95%CI 36.9-42.1). These rates were 16.5% and 37.7%, respectively for patients with M+I-P-. Compliance to the triage protocol for patients with M+I-P- was 78.7%. Furthermore, compliance in patients with either a positive I+ or positive P+ was 91.2%. CONCLUSION: The overall rate of undertriage (10.8%) was mainly influenced by a high rate of undertriage in the group of patients with only a positive mechanism criterion, therefore showing low diagnostic accuracy in selecting severely injured patients. As a consequence these patients with severe injury are undetected using the current triage protocol. As it has been shown that severely injured patients have better outcome in level one trauma care centres further optimisation of this protocol aiming at lowering undertriage is therefore essential, preferably without incrementing overtriage too much.


Subject(s)
Emergency Service, Hospital/statistics & numerical data , Patient Selection , Triage , Wounds and Injuries/diagnosis , Clinical Protocols/standards , Female , Guideline Adherence , Humans , Injury Severity Score , Male , Netherlands , Practice Guidelines as Topic , Predictive Value of Tests , Reproducibility of Results , Retrospective Studies , Sensitivity and Specificity , Trauma Severity Indices , Triage/methods , Wounds and Injuries/mortality
11.
Eur J Trauma Emerg Surg ; 39(1): 3-7, 2013 Feb.
Article in English | MEDLINE | ID: mdl-26814917

ABSTRACT

INTRODUCTION: The development of trauma systems all over the world resulted in improved outcome for a broad range of trauma victims. In this review, we demonstrate the developments of an inclusive regionalised trauma system in the Netherlands and the subsequent developments in our level one trauma centre and trauma region in comparison. COMPARISON WITH OTHER TRAUMA SYSTEMS: With the seasoning of the trauma system, further improvements in outcome could be demonstrated, in the region an OR of 0.84 and in the trauma centre an OR of 0.61, in a later comparison over the years another OR 0.74 was noted. In addition, a further diversification of the trauma populations was seen in the various hospitals with different levels, based on a pre-hospital triage system. Torso and multiple injured patients were more seen in the trauma centre and increased to more than 350 patients with an ISS of >15, whereas monotrauma was almost exclusively seen in the level two and three hospitals. The further development of the trauma system is discussed, in which the minimum requirements of the individual trauma surgeon and institution are taken as a guideline. FUTURE, DISCUSSION AND CONCLUSION: Based on these considerations, a further concentration of the most severely injured patients is proposed in a small country as the Netherlands culminating in one trauma centre for the most severely injured patients, combined with an integrated pre-hospital helicopter system, on top of the current good functioning inclusive trauma system. These developments could be a template for further developments of trauma systems in Europe.

12.
Eur J Trauma Emerg Surg ; 39(4): 375-83, 2013 Aug.
Article in English | MEDLINE | ID: mdl-26815398

ABSTRACT

OBJECTIVE: The classical trimodal distribution of trauma deaths describes three peaks of deaths following trauma: immediate, early and late deaths. The aim of this study was to evaluate whether further maturation of the trauma centre and the improvement of survival have had an effect on the time of death distribution and resulted in a shift in causes of death. METHODS: All trauma patients from 1999 to 2010 who died after arrival in the emergency room and prior to discharge from the hospital were included. Deaths caused by drowning, poisoning and overdose were excluded. RESULTS: A total of 16,421 trauma patients were admitted to our hospital. 772 (4.7 %) patients died, of which 720 were included in this study. The trauma mechanism was predominantly blunt (94.7 %). 530 patients (73.6 %) had Injury Severity Score (ISS) ≥25. The most frequent causes of death were central nervous system (CNS) injury (59.9 %), exsanguinations (12.9 %) and pneumonia/respiratory insufficiency (8.5 %). The first peak of death was seen in the first hour after arrival at the emergency department; subsequently, a rapid decline was observed and no further peaks were seen. Over the years, we observed a general decrease in deaths due to exsanguination (p = 0.035) and a general increase in deaths due to CNS injury (p = 0.004). CONCLUSION: The temporal distribution of trauma deaths in our hospital changed as maturation of the trauma centre occurred. There is one peak of trauma deaths in the first hour after admission, followed by a rapid decline; no trimodal distribution was observed. Over time, there was a decrease in exsanguinations and an increase of deaths due to CNS injury.

13.
Eur J Vasc Endovasc Surg ; 36(1): 45-52, 2008 Jul.
Article in English | MEDLINE | ID: mdl-18396071

ABSTRACT

INTRODUCTION: The practice of carotid endarterectomy (CEA) with patch angioplasty is more effective compared to primary closure. However, the type of patch material remains a controversy. The Fluoropassiv thin wall carotid patch is a polyester patch with an interpenetrating, nanometer-scale, solvent-applied surface modification, based on a biocompatible fluoropolymer. The present pilot study is the first clinical trial evaluating results of CEA with Fluoropassiv versus venous patch. MATERIALS/METHODS: Eighty-seven patients were randomized to 42 Fluoropassiv patching and 45 venous patching. Patients were observed by a vascular surgeon and a neurologist and scanned using duplex ultrasound with a follow-up of 2 years. No patients were lost to follow-up. Restenosis was defined as a Peak Systolic Velocity ratio >2.6, lumen reduction >50%. RESULTS: Perioperative stroke rate was 2.4% in the Fluoropassiv group and 8.9% in the venous group (p=0.02; 1 regressive, 4 non-regressive strokes). Multivariate analysis showed that bilateral carotid stenosis and stroke as indication for CEA were related to perioperative stroke. There was no link between perioperative stroke and patch type after correction for these factors. Patch type had no influence on operation time, clamp time, cranial nerve damage, hypertension, hematoma, infections, time to discharge, or early thromboembolic events. There were no significant differences between the Fluoropassiv and the venous group for cumulative mortality (respectively 4.4 vs 4.8%), patch occlusion (4.8 vs 2.2%), or stroke rate during 2 year follow-up (2.2 vs 2.4%). CONCLUSION: This first clinical study with the Fluoropassiv thin wall carotid patch showed no enhanced thrombogenicity compared to a venous patch. The Fluoropassiv patch is not related to a higher rate of postoperative bleeding events either.


Subject(s)
Angioplasty/methods , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Carotid Stenosis/surgery , Endarterectomy, Carotid , Saphenous Vein/transplantation , Adult , Angioplasty/adverse effects , Angioplasty/instrumentation , Blood Vessel Prosthesis Implantation/adverse effects , Carotid Stenosis/diagnostic imaging , Female , Humans , Male , Middle Aged , Pilot Projects , Polyesters , Prospective Studies , Prosthesis Design , Time Factors , Treatment Outcome , Ultrasonography
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