PubMed Health⌕ Search

Biomedical subjects

Dawn W Blackhurst

Publications and source records attributed to Dawn W Blackhurst.

At least 19 recordsLinked to original sources
PubMed2006

Determinants of functional outcome after revascularization for critical limb ischemia: an analysis of 1000 consecutive vascular interventions.

BACKGROUND: When reporting standards for successful lower extremity revascularization were established, it was assumed that arterial reconstruction, patency, and limb salvage would correlate with the ultimate goal of therapy: improved functional performance. In reality, factors determining improvement of ambulation and maintenance of independent living status after revascularization have been poorly studied. The purpose of this study was to assess the important determinants of functional outcome for patients after intervention for critical limb ischemia. METHODS: The results of 1000 revascularized limbs from 841 patients were studied. Indications were rest pain, 41.1%; ischemic ulceration, 35.6%; gangrene, 23.3%; infrainguinal, 70.9%; aortoiliac, 24.2%; and both, 4.9%. Treatment was by endovascular intervention, 35.5%; open surgery, 61.7%; and both, 2.8%. Patient were mean age of 68 +/- 12 years, and 56.6% were men, 74.7% were white, 54.2% had diabetes mellitus, 67% were smokers, 13.4% had end-stage renal disease and were on dialysis, and 36% had prior vascular surgery. Patients were treated with conventional therapy by fellowship-trained vascular specialists at a single center and were analyzed according to the type of intervention, the arterial level treated, age, race, gender, presentation, the presence of diabetes, smoking history, end-stage renal disease, coronary disease, hypertension, hyperlipidemia, obesity, chronic obstructive pulmonary disease, previous stroke, dementia, prior vascular surgery, preoperative ambulatory status, limb loss <or=1 year of treatment, and independent living status. The technical outcomes of reconstruction patency and limb salvage as well as the functional outcomes of survival, maintenance of ambulation, and independent living status were measured for each variable using Kaplan-Meier life-table analysis, and differences were assessed using the log-rank test. A Cox proportional hazards model was used to assess independent predictors of outcome and obtain adjusted hazard ratios and 95% confidence intervals. RESULTS: At 5 years, 72.4% of the entire cohort had a patent reconstruction and 72.1% had an intact limb. Overall 5-year functional outcomes were 41.9% for survival, 70.6% for maintenance of ambulation, and 81.3% for independent living status. Outcome was not significantly affected by the type of treatment (endovascular or open surgery) or by the level of disease treated (aortoiliac, infrainguinal, or both). The most important independent, statistically significant predictors of particularly poor functional outcome were impaired ambulatory ability at the time of presentation (70% 5-year mortality, hazard ratio, 3.34; 39.5% failure to eventually ambulate, hazard ratio, 2.83; 30% loss of independent living status, hazard ratio, 7.97), and the presence of dementia (73% late mortality, hazard ratio, 1.57; 41.2% failure to eventually ambulate, hazard ratio, 2.20; 46.4% loss of independent living status, hazard ratio, 5.44). These factors were even more predictive than limb amputation alone. CONCLUSION: Functional outcome for patients undergoing intervention for critical limb ischemia is not solely determined by the traditional measures of reconstruction patency and limb salvage, but also by certain intrinsic patient comorbidities at the time of presentation. These findings question the benefit of our current approach to critical limb ischemia in functionally impaired, chronically ill patients--patients who undoubtedly will be more prevalent as our population ages.

Adult↗
PubMed2006

One-year prospective quality-of-life outcomes in patients treated with angioplasty for symptomatic peripheral arterial disease.

BACKGROUND: Despite lower reported patency rates than open bypass, percutaneous transluminal angioplasty (PTA) may result in symptom relief, limb salvage, maintenance of ambulation and independent living, and overall improved quality of life. The goal of this study was to prospectively assess quality of life and functional outcomes after angioplasty and stenting in patients with chronic leg ischemia. METHODS: From August to December 2002, 84 patients with 118 chronically ischemic limbs underwent PTA with or without stenting as part of an ongoing prospective project performed to examine management of symptomatic peripheral arterial disease. All patients completed a preprocedure health questionnaire (Short Form 36) to provide adequate baseline data. Each patient was followed up every 3 months after treatment for 1 year to determine traditional outcomes of arterial patency, limb salvage, survival and amputation-free survival, and functional outcomes assessed according to improvement in quality of life, maintenance of ambulatory status, and maintenance of independent living status. The entire cohort was analyzed, as were subgroups of patients with lifestyle-limiting claudication and those with critical limb ischemia. Outcomes were analyzed by using Kaplan-Meier life-table analysis, the log-rank test for survival curves, and the one-sample t test. A Cox proportional hazard model was used to determine whether presentation and level of disease were independent predictors of outcome. RESULTS: Of the 84 patients, 54 (64.3%) were treated for claudication (34 aortoiliac occlusive disease and 20 infrainguinal disease), and 30 (35.7%) were treated for critical limb ischemia (11 aortoiliac occlusive disease and 19 infrainguinal disease). One-year results for the 54 patients with claudication were as follows: primary patency, 78.5%; limb salvage, 100%; amputation-free survival, 96.3%; survival, 96.3%; maintenance of ambulation status, 100%; and maintenance of independence, 100%. There was statistical improvement in all physical function categories, including physical function (29.4 +/- 8.9 vs 37.1 +/- 11.3; P < .0001), role-physical (32.5 +/- 11.3 vs 39.5 +/- 13.0; P = .0001), bodily pain (35.8 +/- 8.5 vs 42.9 +/- 10.9; P < .0001), and aggregate physical scoring (31.1 +/- 9.7 vs 38.1 +/- 11.5; P < .0001). One-year results for the 30 patients with critical limb ischemia were as follows: primary patency, 35.2%; limb salvage, 77.2%; amputation-free survival, 50.0%; survival, 60.0%; maintenance of ambulation status, 75.8%; and maintenance of independence, 92.8%. There was statistical improvement in bodily pain resolution (35.3 +/- 12.0 vs 46.6 +/- 12.0; P = .0009). Cox models with hazard ratios (HRs) revealed that presentation was a significant predictor for outcomes of primary patency (HR, 4.2; P= .0002), secondary patency (HR, 6.0; P < .0001), limb salvage (HR, 20.2; P = .0047), survival (HR, 10.9; P = .0002), and amputation-free survival (HR, 11.2; P < .0001). Conversely, the level of disease was predictive of outcome only for primary patency (HR, 1.8; P = .00289). CONCLUSIONS: Despite inferior reconstruction patency rates when compared with the historical results of open bypass, PTA provides excellent functional outcomes with good patient satisfaction, especially for treating claudication. These findings support a more liberal use of PTA intervention for patients with vasculogenic claudication.

Algorithms↗
PubMed2006

Validation of the Shriners Hospital for Children Upper Extremity Evaluation (SHUEE) for children with hemiplegic cerebral palsy.

BACKGROUND: The Shriners Hospital for Children Upper Extremity Evaluation (SHUEE) is a video-based tool for the assessment of upper extremity function in children with hemiplegic cerebral palsy. This tool includes spontaneous functional analysis and dynamic positional analysis and assesses the ability to perform grasp and release. The purpose of the present study was to assess the reliability, concurrent validity, and construct validity of this instrument. METHODS: The Shriners Hospital for Children Upper Extremity Evaluation studies for eleven subjects with hemiplegic cerebral palsy were selected for the evaluation of intraobserver and interobserver reliability. Concurrent validity was determined through analysis of the Shriners Hospital for Children Upper Extremity Evaluation, Pediatric Evaluation of Disability Inventory, and Jebson-Taylor Test of Hand Function scores for twenty children. Construct validity was determined through analysis of Shriners Hospital for Children Upper Extremity Evaluation scores for eighteen children before and after flexor carpi ulnaris to extensor carpi radialis brevis tendon transfer. RESULTS: The absolute mean differences between the two scoring sessions for three raters were 1.2 and 1.0 for the spontaneous functional analysis and the dynamic positional analysis, respectively. Although the mean differences were significantly different from 0 (p < 0.001 and p = 0.003), the differences were small and not clinically important with regard to the total possible score. There was excellent intraobserver reliability between the two sessions with regard to both spontaneous functional analysis (r = 0.99) and dynamic positional analysis (r = 0.98). Assessment of interobserver reliability revealed absolute mean differences between four raters of 3.8 and 3.7 for the spontaneous functional analysis and the dynamic positional analysis, respectively. These differences were significantly different from 0 (p < 0.001); however, the magnitudes of these differences were not important with regard to total score or clinical interpretation. There was excellent interobserver reliability for both the spontaneous functional analysis (r = 0.90) and the dynamic positional analysis (r = 0.89). There was 100% agreement within and between examiners for the grasp-and-release section. The Shriners Hospital for Children Upper Extremity Evaluation showed fair correlation with the self-care scaled score from the Pediatric Evaluation of Disability Inventory (r = 0.47) and good inverse correlation with the non-dominant total time section of the Jebson-Taylor test (r = -0.76). The Shriners Hospital for Children Upper Extremity Evaluation wrist score improved for all eighteen subjects after the flexor tendon transfer, and the mean improvement was significant (p < 0.001). CONCLUSIONS: The present study establishes the clinical reliability, concurrent validity, and construct validity of the Shriners Hospital for Children Upper Extremity Evaluation for the assessment of upper extremity function in children with hemiplegic cerebral palsy.

Adolescent↗
PubMed2006

Prosthetic management of children with unilateral congenital below-elbow deficiency.

BACKGROUND: There is substantial controversy concerning the prosthetic management of children with unilateral congenital below-elbow deficiency. The optimal age at the time of the initial fitting, the value of intensive prosthetic training, and the preferred prosthetic design for these children have not been established. METHODS: The outcomes of prosthetic management for 260 children with unilateral congenital below-elbow deficiency, treated between 1954 and 2004, were analyzed with respect to ongoing clinic attendance and self-reported prosthetic use. A successful prosthetic outcome was defined as a child and parents who continued to attend the limb-deficiency clinic and claimed at the time of the most recent follow-up that the prosthesis had been worn for any period of time. An unsuccessful prosthetic outcome was defined as a child and parents who were lost to follow-up or who claimed at the time of the most recent follow-up that the child never wore the prosthesis. Survival analysis was performed. RESULTS: An unsuccessful prosthetic outcome was noted for 127 children (49%). Initial fitting prior to the age of three years was associated with improved prosthetic outcome (p < 0.001). With the numbers studied, there was no additional benefit noted for fitting before one year of age (p = 0.60). Improved prosthetic outcomes were noted in children who had received intensive training at the time of fitting with an active terminal device (p = 0.005). Provision of a variety of prosthetic designs over the growing years was also associated with improved prosthetic outcome (p < 0.001). CONCLUSIONS: This study supports the initial prosthetic fitting for a child with unilateral congenital below-elbow deficiency prior to the age of three years, the provision of intensive training under the direction of an occupational therapist when an active terminal device is applied, and utilization of a variety of prosthetic designs over the child's years of growth. Further analysis of outcomes for the prosthetic management of these children will require more precise definitions of outcome in multiple domains and the development and validation of specific outcome instruments.

Age Factors↗
PubMed2006

Does obesity predict functional outcome in the dysvascular amputee?

Limited information is available concerning the effects of obesity on the functional outcomes of patients requiring major lower limb amputation because of peripheral arterial disease (PAD). The purpose of this study was to examine the predictive ability of body mass index (BMI) to determine functional outcome in the dysvascular amputee. To do this, 434 consecutive patients (mean age, 65.8 +/- 13.3, 59% male, 71.4% diabetic) undergoing major limb amputation (225 below-knee amputation, 27 through-knee amputation, 132 above-knee amputation, and 50 bilateral) as a complication of PAD from January 1998 through May 2004 were analyzed according to preoperative BMI. BMI was classified according to the four-group Center for Disease Control system: underweight, 0 to 18.4 kg/m2; normal, 18.5 to 24.9 kg/m2; overweight, 25 to 29.9 kg/m2; and obese, > or = 30 kg/m2. Outcome parameters measured included prosthetic usage, maintenance of ambulation, survival, and maintenance of independent living status. The chi2 test for association was used to examine prosthesis wear. Kaplan-Meier curves were constructed to assess maintenance of ambulation, survival, and maintenance of independent living status. Multivariate analysis using the multiple logistic regression model and a Cox proportional hazards model were used to predict variables independently associated with prosthetic use and ambulation, survival, and independence, respectively. Overall prosthetic usage and 36-month ambulation, survival, and independent living status for the entire cohort was 48.6 per cent, 42.8 per cent, 48.1 per cent, 72.3 per cent, and for patients with normal BMI was 41.5 per cent, 37.4 per cent, 45.6 per cent, and 69.5 per cent, respectively. There was no statistically significant difference in outcomes for overweight patients (59.2%, 50.7%, 52.5%, and 75%) or obese patients (51.8%, 46.2%, 49.7%, and 75%) when compared with normal patients. Although there were significantly poorer outcomes for underweight patients for the parameters of prosthetic usage when compared with the remaining cohort (25%, P = 0.001) and maintenance of ambulation when compared with overweight patients (20.8%, P = 0.026), multivariate analysis adjusting for medical comorbidities and level of amputation showed that BMI was not a significant independent predictor of failure for any outcome parameter measured. In conclusion, BMI failed to correlate with functional outcome and, specifically, obesity did not predict a poorer prognosis.

Aged↗
PubMed2006

Differential expression of prognostic factors and effect on survival in young (< or =40) breast cancer patients: a case-control study.

The belief that young women develop more aggressive forms of breast cancer than other women is controversial. The purpose of this study was to determine if women 40 years of age and under with breast cancer have more negative prognostic indicators and a higher 5-year mortality than those women over 40 years of age. From January 1998-December 2002, all women with breast cancer were identified from our tumor registry. Women with metastatic disease at presentation were excluded from our study. The women were divided into two groups, women under 40 (cases) and women 40 and over (controls). Seventy-eight cases were identified and matched to 228 controls. These cohorts were matched 3:1 (cases:controls) based on tumor staging. The data collected on each patient included prognostic factors such as tumor size, tumor type, estrogen and progesterone receptors, Her2/neu, and Ki-67. Information on surgical procedure, postoperative therapy, recurrence, and mortality was also gathered. The mean ages for cases and controls were 35 and 59 years, respectively. The rates of modified radical mastectomy were similar in the two groups, but young women were more likely to have breast reconstruction (33.7% vs 9.8%). The rates of breast conservation therapy were actually lower in the group under 40 (32.5% vs 37.6%). Tumors in the 40 and under group were more frequently estrogen receptor negative (33.8% vs 21.9%: P = 0.046) and progesterone receptor negative (50.0% vs 35.5%: P = 0.033). Younger women also experienced a greater prevalence of Ki-67 (P < 0.001) and higher levels of Her2/neu overexpression (P = 0.013). Women over 40 were more likely to receive hormonal therapy (39.7% vs 36.1%). Women over 40 had a lower overall rate of recurrence. A difference in overall survival does exist between these two groups of women, which trends toward significance. The women 40 and under had a lower overall 5-year survival. The reason for this difference remains unclear. Although we demonstrate a higher percentage of younger women with negative biochemical markers, the only factors independently and significantly related to higher mortality were estrogen receptor negativity and tumor stage at presentation.

Adult↗
PubMed2005

Safety and efficacy of reteplase for the treatment of acute arterial occlusion: complexity of underlying lesion predicts outcome.

We evaluated both the safety and efficacy of reteplase for treatment of acute arterial occlusion as well as outcomes based on treatment of the underlying lesion. From November 2000 to February 2004, reteplase was used to treat arterial occlusions in 81 patients. Catheter-directed intrathrombus thrombolysis was performed with reteplase (0.5 units/hr) continuous infusion. Percutaneous mechanical thrombectomy (Angiojet) was performed in 61% (n = 50) of patients prior to thrombolysis. Unmasking of significant lesions resulted in endovascular intervention (39.5%), open surgical repair (24.6%), or both endovascular and surgical repair (9.8%) of the lesion. No lesion was found in 25.9% of patients. Major and minor complication rates as well as restoration of patency, limb salvage, and amputation-free survival were evaluated. Eighty-one patients received reteplase therapy (median = 10.3 +/- 5.3 units, 19.5 +/- 7.4 hr) followed by next-day arteriogram to assess thrombus removal. Technical success was achieved in 96.2% (n = 78) of cases. Kaplan-Meier life table analysis revealed overall primary patency rates of 76.3%, 60.1%, and 51.6%, at 1, 6, and 12 months, respectively. Overall amputation-free survival rates were 86.4%, 76.4%, and 69.7% at 1, 6, and 12 months, respectively. When subdivided into postlysis intervention, the lysis-only group achieved increased patency (p = 0.0143) and increased limb salvage (p = 0.0219) at 1 year compared to the lysis and endovascular intervention and the lysis and surgical groups. The 30-day complication rate was 17.3% (n = 14), with a major complication rate of 4.9% (n = 4) and a minor complication rate of 12.3% (n = 10). There were no intracranial hemorrhagic complications. Intra-arterial catheter-directed infusion of reteplase for acute lower extremity ischemia is safe and efficacious, as shown by the low risk of bleeding complications, high limb salvage rates, and low mortality rates in this study. The complexity of the lesion that is unmasked through thrombolytic therapy is a predictor of patency and limb salvage.

Acute Disease↗
PubMed2005

Developing techniques for determining sperm morphology in today's andrology laboratory.

PURPOSE: To investigate three areas: the staining of spermatozoa; the Computer Assisted Semen Analysis (CASA); and the variability of technicians. METHODS: Staining experiment: sperm from 15 beef bulls were randomized to one of three staining protocols. CASA experiment: slides were evaluated using the Integrated Visual Optical System and compared to technician results. Variability of technicians: five laboratorians analyzed the same set of 20 slides six different times. RESULTS: Staining experiment: the size of the sperm increased in proportion to increased time and heat associated with each successive protocol. CASA experiment: coefficient of variation ranged from 18.3 to 101.7% (12 slides). Variability of technicians: the mean sperm morphology results ranged from 7.3 to 15% normal forms. CONCLUSIONS: Until laboratories adhere to the universal standard set by the World Health Organization to evaluate sperm morphology, a laboratory must rely on its own quality control to insure repeatable results.

Adult↗
PubMed2005

Changes in the freezing protocol for human zygotes alter embryonic development and pregnancy rates.

OBJECTIVE: To determine the effect of various freezing protocols on postthaw development and pregnancy rates resulting from transfer of human zygotes. DESIGN: Prospective study. SETTING: Tertiary care center. PATIENT(S): Couples undergoing assisted reproductive technology (ART) procedures who wished to have their excess zygotes cryopreserved. INTERVENTION(S): We cryopreserved zygotes with one of three protocols. MAIN OUTCOME MEASURE(S): Post-thaw survival and development of the zygotes as well as pregnancy rate after transfer of these zygotes. RESULT(S): A 3-minute hold time after seeding, followed by a final preplunging temperature of -180 degrees C, resulted in a clinical pregnancy rate of 28.6%. In contrast, a 15-minute postseed hold time and a -30 degrees C final chamber temperature resulted in a 37.3% clinical pregnancy rate. When we combined the protocols to provide a 15-minute postseed holding time and a -180 degrees C before plunging into liquid nitrogen, we achieved a 69.6% clinical pregnancy rate. CONCLUSION(S): By increasing the postseeding hold time and decreasing the temperature of the freezing chamber before plunging the zygotes into liquid nitrogen, significant improvements can be made in postthaw development and pregnancy rates.

Adult↗
PubMed2005

Preoperative clinical factors predict postoperative functional outcomes after major lower limb amputation: an analysis of 553 consecutive patients.

BACKGROUND: Despite being a major determinant of functional independence, ambulation after major limb amputation has not been well studied. The purpose, therefore, of this study was to investigate the relationship between a variety of preoperative clinical characteristics and postoperative functional outcomes in order to formulate treatment recommendations for patients requiring major lower limb amputation. METHODS: From January 1998 through December 2003, 627 major limb amputations (37.6% below knee amputations, 4.3% through knee amputations, 34.5% above knee amputations, and 23.6% bilateral amputations) were performed on 553 patients. Their mean age was 63.7 years; 55% were men, 70.2% had diabetes mellitus, and 91.5% had peripheral vascular disease. A retrospective review was performed correlating various preoperative presenting factors such as age at presentation, race, medical comorbidities, preoperative ambulatory status, and preoperative independent living status, with postoperative functional endpoints of prosthetic usage, survival, maintenance of ambulation, and maintenance of independent living status. Kaplan-Meier survival curves were constructed and compared by using the log-rank test. Odds ratios (OR) and hazard ratios (HR) with 95% confidence intervals were constructed by using multiple logistic regressions and Cox proportional hazards models. RESULTS: Statistically significant preoperative factors independently associated with not wearing a prosthesis in order of greatest to least risk were nonambulatory before amputation (OR, 9.5), above knee amputation (OR, 4.4), age > 60 years (OR, 2.7), homebound but ambulatory status (OR, 3.0), presence of dementia (OR, 2.4), end-stage renal disease (OR, 2.3), and coronary artery disease (OR, 2.0). Statistically significant preoperative factors independently associated with death in decreasing order of influence included age > or = 70 years (HR, 3.1), age 60 to 69 (HR, 2.5), and the presence of coronary artery disease (HR, 1.5). Statistically significant preoperative factors independently associated with failure of ambulation in decreasing order of influence included age > or = 70 years (HR, 2.3), age 60 to 69 (HR, 1.6), bilateral amputation (HR, 1.8), and end-stage renal disease (HR, 1.4). Statistically significant preoperative factors independently associated with failure to maintain independent living status in decreasing order of influence included age > or = 70 years (HR, 4.0), age 60 to 69 (HR, 2.7), level of amputation (HR, 1.8), homebound ambulatory status (HR, 1.6), and the presence of dementia (HR, 1.6). CONCLUSIONS: Patients with limited preoperative ambulatory ability, age > or = 70, dementia, end-stage renal disease, and advanced coronary artery disease perform poorly and should probably be grouped with bedridden patients, who traditionally have been best served with a palliative above knee amputation. Conversely, younger healthy patients with below knee amputations achieved functional outcomes similar to what might be expected after successful lower extremity revascularization. Amputation in these instances should probably not be considered a failure of therapy but another treatment option capable of extending functionality and independent living.

Aged↗
PubMed2005

The general surgery model: a more appealing and sustainable alternative for the care of trauma patients.

The contemporary model of trauma care where dedicated trauma/critical care surgeons exclusively manage trauma patients has become progressively unsustainable. Little objective data, however, is available documenting that a better model exists. From September 2002 through August 2003, the trauma model at a 735-bed level I trauma teaching hospital was changed from the contemporary model to a new one where selected general surgeons with Advanced Trauma Life Support (ATLS) certification covered in-house trauma and emergency surgery call on a rotational basis. As well, each pursued elective practices, admitting all inpatients (trauma, emergent, elective) to a single teaching service (formerly the trauma service). Critical care was managed by a separate group of intensivists. The purpose of this study was to objectively compare the two models. Quantitative, financial, and qualitative data were derived from August 2001 to January 2002 (trauma/critical care model) and compared to August 2003 to January 2004 (general surgery model). During the two periods (trauma/critical care vs general surgery), the mean Revised Trauma Score (7.1 vs 7.2; P = 0.029), the mean Injury Severity Score (ISS) (10.9 vs 10.8; P = 0.84), and the percentage of penetrating trauma (12.5% vs 13.2%; P = 0.79) were similar. Differences (trauma/critical care vs general surgery, % increase/P value) included average daily census (24 vs 54, 225%), cases/attending (262 vs 543, 207%), cases/resident (54 vs 262, 485%), charges/attending (353,811 dollars vs 471,725 dollars, 133%), collections/attending (106,143 dollars vs 165,103 dollars, 156%), number of trauma patients (643 vs 748, 116%), trauma mortality (7.3% vs 4.0%; P = 0.007), trauma mortality with ISS >15 (21.7% vs 12.0%; P = 0.035), trauma complications (33.1% vs 17%; P < 0.001), and ICU morbidity (66.8% vs 43.9%; P < .001). The new general surgery model produced superior financial results and better quantitative surgical experience while exceeding trauma and ICU quality outcomes compared to the former trauma/critical care model. These data objectively support a model such as ours--one that is financially sustainable and more professionally attractive.

Adolescent↗
PubMed2005

Postoperative outcomes according to preoperative medical and functional status after infrainguinal revascularization for critical limb ischemia in patients 80 years and older.

The purpose of this study was to provide outcomes after intervention for critical limb ischemia (CLI) in elderly patients (> or =80 years) according to medical and functional status at presentation. From January 1998 to September 2003, 140 limbs/122 patients (age range 80-97 years) were treated (57 patients/66 limbs, infrainguinal bypass; 65 patients/74 limbs, infrainguinal angioplasty) for CLI. At presentation, 71 (58.2%) patients were functionally ambulatory, 41 (33.6%) were homebound ambulators, and 10 (8.2%) were transfer-only ambulators. Overall end points after treatment as well as outcomes according to type of treatment and preoperative medical and functional status were determined. End points included reconstruction patency, limb salvage, survival, amputation-free survival, and maintenance of ambulatory and independent living status. Results for the 140 limbs/122 patients at 3 years (Kaplan-Meier curves) include primary patency, 55.3%; secondary patency, 73.2%; limb salvage, 78.3%; survival, 62.5%; amputation-free survival, 49.7%; maintenance of ambulation, 77.8%; and maintenance of independent living status, 82.9%. There was essentially no difference in outcomes based on type of treatment (endovascular vs open operation). When analyzing 2-year outcomes by functional status (ambulatory vs homebound vs transfer), there was deterioration in outcomes according to declining functional status at presentation for mortality (84.7% vs 66.4% vs 42%; P < 0.001), amputation-free survival (73.3% vs 48.2% vs 36.9%; P < 0.001), limb salvage (86% vs 66.5% vs 71.9%; P = 0.022), and secondary patency (84.3% vs 61.5% vs 69.2%; P = 0.005) regardless of treatment. Homebound ambulators were two times and transfer-only patients five times more likely to experience death (Cox hazard model); diabetics were four times more likely to lose a limb and experience a decline in ambulation and living status. Overall medical and functional status at presentation predicts postoperative functional outcomes. These data support a policy of aggressive vascular intervention in the functional elderly and clinical restraint in the functionally impaired patient with CLI.

Aged↗
PubMed2004

Conclusions about the effects on fertilization of time from aspiration to incubation and blood in the aspirate depend on the use of appropriate statistical techniques.

OBJECTIVE: To examine the effects of exposure to blood and time from aspiration to incubation on oocyte fertilization. DESIGN: Retrospective, cohort study. SETTING: Hospital-based IVF practice. PATIENT(S): Eighty-two women undergoing IVF procedures. INTERVENTION(S): Patients received a standard gonadotropin protocol or a microdose flare protocol. MAIN OUTCOMES MEASURE(S): Logistic regression was used to estimate odds of nonfertilization, adjusting for maternal age, time from aspiration to incubation, presence of blood in the aspirate, and a time-by-blood interaction. Two statistical methods were used: an analysis that assumed oocytes were independent and an analysis that adjusted for the lack of independence of oocytes within mothers (i.e., cluster-correlated data). RESULT(S): The 82 women contributed 1093 oocytes. In a model with blood dicotomized as present or absent, and with time elapsed and maternal age categorized into quartiles, both time and maternal age were statistically significant when conventional logistic regression was used. In analyses that accounted for clustering within mother, retrieval-to-incubation times more than 4 minutes were associated with an increased risk of nonfertilization, but age and blood were not; there was no evidence of an interaction between time elapsed and blood. CONCLUSION(S): If appropriate statistics are applied, retrieval-to-incubation times more than 4 minutes are associated with increased risk of nonfertilization.

Adult↗
PubMed2004

Expectations for oocyte fertilization and embryo cleavage after whole sperm versus sperm head intracytoplasmic sperm injection.

OBJECTIVE: To compare oocyte fertilization and embryo development after intracytoplasmic sperm injection (ICSI) with a whole sperm vs. a sperm head. DESIGN: Retrospective study. SETTING: Hospital-based IVF practice. PATIENT(S): Fifty-three women undergoing 54 IVF-embryo transfer plus ICSI procedures between January 1999 and June 2002. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Oocyte fertilization, zygote cleavage, and embryo stage after 72 hours of culture. RESULT(S): A significantly higher fertilization rate was observed using whole sperm (72.2%) than when using sperm heads (56.4%). Zygote cleavage rates for whole sperm vs. sperm head ICSI were 96.4% and 92.7%, respectively. Embryo cell stage after 72 hours of culture for whole sperm vs. sperm head ICSI was 6.5 +/- 2.1 cells and 5.6 +/- 1.8 cells, respectively. Embryo grade at this same time point was not different (2.3 +/- 1.0 and 2.5 +/- 0.9, respectively). CONCLUSION(S): The ICSI using whole sperm produces superior fertilization rates compared to ICSI using sperm heads, but once oocytes were fertilized, zygote cleavage rates were not different between the two sperm sources. Oocytes injected with a whole sperm produced embryos of higher cell stage but equivalent quality compared to oocytes injected with sperm heads. Therefore, having only sperm heads for use in ICSI should not be a deterrent to using this procedure.

Adult↗
PubMed2004

Invasive treatment of chronic limb ischemia according to the Lower Extremity Grading System (LEGS) score: a 6-month report.

BACKGROUND: The invasive treatment of chronic lower extremity peripheral arterial disease (PAD) has become inconsistent. To standardize treatment at our institution, the Lower Extremity Grading System (LEGS) score was devised, based on arteriographic findings, symptoms, functional status, comorbid conditions, and technical factors. The scoring system was used to direct the invasive treatment approach in patients with lower extremity PAD. The purpose of this study was to prospectively assess outcomes of invasive treatment of lower extremity ischemia as directed by LEGS. METHODS: From March 2002 through December 2002, 332 limbs in 227 patients with indications for intervention were scored and treated according to the LEGS score and followed for 6 months. Of the 227 patients, 66.1% were male; median age was 65 years. Diabetes mellitus was present in 44.9% of patients, claudication in 48.5%, and limb-threatening ischemia in 51.5%. Results of treatment as directed by LEGS were judged with the treatment outcome measures of reconstruction patency, limb salvage, mortality, change in ambulatory status, change in independent living status, and change in the short-form health survey (SF-36). RESULTS: Of 332 limbs, 61.5% with a score of 10 to 19 underwent endovascular therapy; 34% with a score of 0 to 9 underwent open revascularization; and 4.5% with a score greater than 20 underwent primary limb amputation. Interventions for the entire cohort as directed by LEGS resulted in 6-month primary reconstruction patency of 82.4%; secondary reconstruction patency, 92.6%; limb salvage, 90%; survival, 89.1%; maintenance of ambulatory status, 85.6%; maintenance of independent living, 88.4%; and statistically significant improvement in health assessment, regardless of treatment type, as determined with the SF-36. There was no statistically significant variability when comparing results according to treatment (open surgery, 0-9 vs endovascular therapy, 10-19) or smaller score group categories (0-5, 6-9, 10-13, 14-19). CONCLUSIONS: At 6 months, treatment as directed by LEGS score resulted in acceptable outcomes. This project is the first reported prospectively confirmed standardization tool for treatment of lower extremity PAD, and, pending independent confirmation by others, provides a comparative baseline against which other standardization efforts can be measured.

Adult↗
PubMed2004

Does a standardization tool to direct invasive therapy for symptomatic lower extremity peripheral arterial disease improve outcomes?

OBJECTIVES: While decision analysis and treatment algorithms have repeatedly been shown to improve quality of care in many areas of medicine, no such algorithm has emerged for the invasive management of lower extremity peripheral arterial disease. Using the best available evidence-based outcomes data, our group designed a standardization tool, the Lower Extremity Grading System (LEGS) score, which consistently directs limbs to a specific treatment on the basis of presentation. The purpose of this study was to examine whether use of such a tool improves outcomes by directing treatment of lower extremity peripheral arterial disease. METHODS: Over 18 months (July 2001-December 2002) our group intervened in 673 limbs (angioplasty, open surgery, primary limb amputation) with lower extremity peripheral arterial disease. During this time we developed the LEGS score, and implemented its prospective use for the final 362 limbs. For the purpose of this study, all 673 limbs were retrospectively scored with the LEGS score to determine the LEGS recommended best treatment. Of the 673 limbs, 551 (81.9%) received the same treatment as recommended with LEGS and 122 (18.1%) received treatment contrary to LEGS. Limbs treated contrary to LEGS (cases) were then compared with matched control limbs (treated according to LEGS), with similar angiographic findings, clinical presentation, preoperative functional status, comorbid conditions and operative technical factors. Outcomes measured at 6 months included arterial reconstruction patency, limb salvage, survival, and maintenance of ambulatory status and independent living status. Kaplan-Meier curves were used to assess patency, limb salvage, and survival; associated survival curves were compared with the log-rank test. Functional outcomes were compared with the Fisher exact test. RESULTS: After matching case limbs with control limbs, 9 limbs had no control match. Thus 113 limbs in 100 patients treated contrary to LEGS were compared with 113 limbs in 100 patients treated according to LEGS. Limbs treated contrary to LEGS resulted in significantly inferior outcomes at 6 months for measures of primary patency (57.5% vs 84.3%; P < .001), secondary patency (73.2% vs 96.2%; P < .001), limb salvage (89.7% vs 97.2%; P = .04), and maintenance of ambulatory status (78% vs 92%; P = .02). As an additional finding, 29.6% (92 of 311) of interventions performed before implementation of the algorithm were treated contrary to LEGS, and thus contrary to objectively determined best therapy, compared with 8.3% (30 of 362) after LEGS implementation (P < .001). CONCLUSIONS: Limbs treated according to our standardization tool resulted in better outcomes compared with limbs treated contrary to the algorithm. These data suggest that routine use of an appropriately validated treatment standardization algorithm is capable of improving overall results for invasive treatment of lower extremity peripheral arterial disease.

Amputation, Surgical↗
PubMed2004

Prosthetic thigh arteriovenous access: outcome with SVS/AAVS reporting standards.

PURPOSE: Differences in the reporting methods of results for arteriovenous (AV) access can dramatically affect apparent outcome. To enable meaningful comparisons in the literature, the Society for Vascular Surgery and the American Association for Vascular Surgery (SVS/AAVS) recently published reporting standards for dialysis access. The purpose of the present study was to determine infection rates, patency rates, and possible predictive factors for prosthetic thigh AV access outcomes with the reporting standards of the SVS/AAVS. METHODS: A retrospective analysis was performed of all patients who underwent placement of thigh AV access by the Surgical Teaching Service at Greenville Memorial Hospital between 1989 and 2001. Outcomes were determined based on SVS/AAVS Standards for Reports Dealing with AV Accesses. The rate of revision per year of access patency was also determined; this end point more accurately reflects the true cost and morbidity associated with AV access than do patency or infection rates alone. RESULTS: One hundred twenty-five polytetrafluoroethylene thigh AV accesses were placed in 100 patients. Nine accesses were excluded from the study, six because there was no patient follow-up and 3 as a result of deaths unrelated to the access procedure and which occurred less than 30 days after access placement. There were six (4%) late access-related deaths. There were 18 (15%) early access failures, related to infection in 14 cases (12%), thrombosis in three cases (2%), and steal in one case (1%). Early failure was more common in patients with diabetes mellitus (P =.036). The primary and secondary functional patency rates were 19% and 54%, respectively, at 2 years. Infection occurred in 48 (41%) accesses. The patency and infection rates were not influenced by patient age, gender, body mass index, or diabetes mellitus. The median number of interventions per year of access patency was 1.68, and this outcome was positively correlated with body mass index (P <.001). CONCLUSIONS: Prosthetic AV access in the thigh is associated with higher morbidity compared with that reported for the upper extremity, and should be considered only if no upper extremity AV access option is available. Early access failure and the requirement for an increased number of interventions to reestablish and maintain access patency are more common in patients with diabetes mellitus and obesity. The number of interventions per year of access patency is a valuable end point when assessing the outcome of AV access procedures.

Blood Vessel Prosthesis Implantation↗
PubMed2004

Longevity of donor serum.

PURPOSE: To determine the viability of long-term, stored serum, which is used in human in vitro production as a source of energy substrates, amino acids, vitamins, growth factors, and other nutrients. METHOD: Two-cell mouse embryos were used in this prospective, cohort study. Serum stored for 1-, 5-, 10-, and 12-year intervals was subjected to four replications of mouse-embryo testing. RESULT(S): There were no significant differences in blastocyst rates between any of the replicates by year (80-100% blastocyst rate; P > 00.1) or between pooled replicate means by time period. CONCLUSION(S): Serum may be frozen up to 12 years.

Animals↗