Epidemiology of abusive head trauma in West Virginia children <24 months: 2000-2010.

BACKGROUND: Few states have published statewide epidemiology of abusive head trauma (AHT). OBJECTIVE: To examine the statewide epidemiology of AHT in West Virginia (WV), with the primary objective of establishing AHT incidence for comparison to national data, and to use as a baseline for comparison to incidence post-implementation of a statewide AHT prevention program. PARTICIPANTS AND SETTING: AHT cases in children less than 2 years old were identified from the 3 tertiary pediatric centers in WV. METHODS: Cases were identified by using ICD-9 codes for initially identifying those with injuries which might be consistent with AHT, followed by medical record review to determine which of these met the criteria for inclusion as a case. Medical examiner data was used to find additional cases of AHT. Using the number of cases identified along with relevant census data, incidence of AHT was calculated. RESULTS: There were 120 cases of AHT treated in WV hospitals from 2000 to 2010, 100 of which were WV residents. The incidence was 36.1/100,000 children <1 year of age and was 21.9 cases per 100,000 children <2 years of age. Incidence in infants increased during the latter years (2006-2010) of the study to 51.8/100,000 compared to the incidence during 2000-2005, which was 24.0/100,000 (p < .01). CONCLUSIONS: Compared to US national, state and regional figures, the WV incidence of AHT was among the highest. In addition, the incidence of AHT increased significantly over the study period. Possible factors contributing to the rise in incidence are discussed.

Changes in Nonosteoporotic Bone Density and Subsequent Fractures in Women.

OBJECTIVES: Osteopenia is considerably more common than osteoporosis and accounts for most of the fracture burden in women older than 50 years. It is uncertain when to initiate treatment in osteopenia. We sought to determine in women with osteopenia what effect transitioning to lower categories had on subsequent fracturing. METHODS: We surveyed 1150 women from office-based practices who had initial normal or osteopenic bone mineral densities (BMDs) and who were retested after 5.75 years. We classified categories related to baseline T scores as follows: normal (>-1.0), mild osteopenia (-1.0 to -1.49), moderate osteopenia (-1.5 to -1.99), and severe osteopenia (-2.0 to -2.49). We determined during a 9.6-year follow-up period the fracture occurrence in those who maintained their initial category status or transitioned into lower categories. RESULTS: Transitioning to lower categories was not significantly different among baseline osteopenic categories but significantly more than normal baseline BMDs. Total fractures, individuals fracturing, and major fractures were significantly more, with baseline T scores of ≤-1.5 (<0.001). Although only 10.2% transitioned to osteoporosis, 90.5% of these transitions occurred with baseline T scores ≤-1.5 and accounted for significantly more fractures than baseline T scores of >-1.5. CONCLUSIONS: Most subsequent fractures and transitions to osteoporosis occurred with baseline T scores ≤-1.5. Clinical risk factors need to be used to determine at what T score threshold treatment would be cost effective.

Thrombotic thrombocytopenic purpura (TTP) following coronary artery bypass: case series and review of the literature.

We reviewed 10 cases of thrombotic thrombocytopenic purpura (TTP) following cardiac surgery since November 1998. The object of the study was to define the natural history of post-CABG-TTP and to assess response to therapy. All patients underwent CABG; four also underwent aortic valve replacement and six mitral valve replacement. Eight patients had mental status changes and/or unexplained fever. All patients received plasmapheresis ranging from 5 to 24 days and nine required hemodialysis or continuous renal replacement therapy. All had significant improvement in their platelet count, LDH, renal function, and mental status changes at discharge. None of the five surviving patients has relapsed at follow-up ranging from 8 months to 6 years. Early recognition of this syndrome and early institution of plasmapheresis are important for a favorable outcome.

Significance of high- and low-distal energy forearm fractures.

OBJECTIVE: To determine in men and women aged 50 years or older the proportion of distal forearm fractures related to high- or low-energy events and subsequent fracturing. METHODS: We reviewed records of patients presenting to emergency departments and urgent care facilities with distal forearm fractures occurring during a 7-year entry period and studied for an additional 3.5 years. RESULTS: High-energy events proportionally were 3.25 times more likely in men, whereas low-energy distal forearm fractures proportionally were 7.98 times more likely in women. Although 25% received bone densitometry evaluations, only 3.59% were performed within the first year after a distal forearm fracture. Osteoporosis and osteopenia did not differ between high- and low-energy distal forearm fractures. In logistic regression, subsequent fractures were associated with prior fracture and age 80 years or older. The occurrence of individuals subsequently fracturing was similar in men and women. Compared with controls, the odds ratio of individuals subsequently fracturing was 1.74 (95% confidence interval 1.32-2.30) in women and 1.9 (95% confidence interval 1.07-3.43) in men. Approximately 60% of total subsequent fractures occurred within 3 years. Osteoporosis was significantly more in patients with distal forearm fractures than controls (P < 0.001), but control patients had significantly more osteopenia (P < 0.001). No differences were noted in therapeutic intervention between those with prior distal forearm fractures and controls. CONCLUSIONS: Regardless of trauma occurrence, both men and women age 50 years and older with recent distal forearm fractures should be evaluated early for treatment by bone densitometry and clinical risk factors because the majority of recurrent fractures occur within 3 years.

Intraoperative utilization of dexamethasone/bupivacaine/gentamicin solution in laparoscopic assisted vaginal hysterectomy and pain management.

Adequately controlling pain is a key component of postoperative care after a hysterectomy. The purpose of this study was to evaluate the effects of two intraperitoneal (IP) administered solutions during Laparoscopic Assisted Vaginal Hysterectomy (LAVH), on the amount of postoperative self-administered morphine. In this prospective, randomized, double blinded study, twenty women undergoing LAVH randomly distributed to two treatment groups: (1) 100 ml dexamethasone/ bupivacaine/ gentamicin (DMG) solution: 60 cc injected vaginally at cuff and 40 cc placed topically via laparoscopy over intra-peritoneal postoperative surfaces (IP) and 5 ml bupivacaine or 5 ml saline injected at the laparoscopic incision sites, (2) 100 ml saline solution: 60 cc injected vaginally at cuff and 40 cc placed topically via laparoscopy over intra-peritoneal postoperative surfaces (IP) and 5 ml bupivacaine or 5 ml saline injected at the laparoscopic incision sites. The amount of morphine utilized by the patients was documented from their patient controlled anesthesia (PCA) pump. Patient parameters recorded included perceived pain score, height, weight, age, race, reason for surgery, pre-surgery medications, American Society of Anesthesiologist (ASA) classification, length of the surgery and estimated blood loss (EBL). Age, EBL, length of surgery, and ASA classification were not significantly different between the groups. The postoperative amount of morphine utilized was higher at 4 (p=.02) and 16 hours (p = .04) and tended to be higher at 8, 12 hours (p=.06), and 24 hours (p=.09) in the saline IP group. Overall the saline IP group (n=10) used (median; range) 21.5; 8-82 mg of morphine while the DMG IP group (n=10) used 10.5; 1-23 mg. No participants reported a postoperative infection. This study demonstrates that intraoperative utilization of DMG solution during LAVH enables patients clinically to have less perceived pain and subsequently tend to utilize about half the amount of morphine, helping to avoid the potential harmful side effects and adverse reactions of morphine.

Risk factors predicting fractures in early postmenopausal women.

Abstract Few studies exist evaluating fracture prediction in women aged 50-59. Clinical risk factors are important determinants for fracture prediction in younger postmenopausal women since most fractures occur outside the range of an osteoporotic bone mineral density. Although fracture incidence rates in this age group are about one-half of those aged 60-69, considerable costs and loss of quality-adjusted life years are still incurred in this age group. We sought to determine what clinical risk factors would predict subsequent fractures. Questionnaires were mailed out to 546 rural women who underwent osteoporosis screening 8.3 years previously by bone densitometry and a 24-item clinical risk factor assessment. Our survey had a 55% response rate and found that 11.9% of respondents had subsequent fractures. A prior fracture history, self-reported rheumatoid arthritis, and menopause age <40 were significantly associated with subsequent fractures. A logistic regression analyses showed only a prior fracture history and menopause age

An approach to identify rural women aged 60 to 64 for osteoporosis treatment.

OBJECTIVES: The US Preventive Services Task Force recently recommended that women younger than 65 years undergo a bone mineral density screening if clinical risk factors (CRFs) of a major osteoporotic fracture are ≥9.3% for a period of 10 years. We sought the most cost-effective approach to identify older, rural women who are eligible for osteoporosis treatment. METHODS: We evaluated CRFs and peripheral forearm densitometry (pDXA) in 277 rural women aged 60 to 64 years for treatment eligibility. We compared three strategies of universal screening-pDXA, CRFs, and exclusion of pDXA in specific situations (prior fracture and CRFs ≥20%)-followed by CRF evaluation with pDXA confirmation in the residual population. RESULTS: Our sample showed that 37.5% of women had CRFs at a ≥9.3% cutoff threshold. Only osteoporotic pDXA values were significantly higher at this threshold. Current estrogen use was significantly associated with diminished treatment eligibility (P = 0.001). Body mass index correlated poorly with pDXA values (r = 0.12) and CRFs (r = 0.21). Although a cost-savings strategy nonsignificantly identified more women who were eligible for treatment using the three strategies (P = 0.25), significantly fewer pDXA examinations were required (P < 0.001). CONCLUSIONS: Initiating treatment in rural women aged 60 to 64 years who had a prior fracture or CRFs ≥20% without pDXA confirmation, followed by pDXA evaluations in the residual population with CRFs between ≥9.3% and 20%, significantly reduced the number of pDXA examinations and the cost of screening.

Safety and pharmacokinetics of ribavirin for the treatment of la crosse encephalitis.

BACKGROUND: La Crosse viral encephalitis (LACVE) is associated with residual epilepsy and neurocognitive deficits in survivors. This report summarizes 3 phases of clinical studies of children treated with intravenous (IV) ribavirin (RBV), each one exploring a different phase (I, IIA, IIB) of clinical trial development. METHODS: In phase I, 7 children with life-threatening LACVE were treated with emergency use RBV using a moderate IV dose (8.33 mg/kg/dose q 8 hours day 1, 5 mg/kg/dose q 8 hours days 2-10). In phase IIA, 12 children with severe LACVE were enrolled: 8 treated with RBV (same dose as phase I) and 4 with placebo. In phase IIB an escalated dose was used (33 mg/kg dose 1, then 16 mg/kg/dose q 6 hours for 4 days, and 8 mg/kg/dose q 8 hours for 3 days). RESULTS: In a group of 15 children treated in phase I and phase IIA, RBV appeared safe at moderate dose, but based on steady-state RBV levels of 9.3 µM, estimated cerebrospinal fluid levels were less than 20% of the EC50 of RBV for LACVE. At the escalated dose used in phase IIB, adverse events occurred, likely related to RBV, and therefore the trial was discontinued. Nevertheless, valuable pharmacokinetic (PK) and safety data were obtained at moderate dose, with potential treatment implications for other indications. CONCLUSIONS: Although the results do not support the use of RBV for LACVE, this nevertheless is the largest study of antiviral treatment for LACVE to date and the largest pharmacokinetic analysis of IV RBV in children for any indication.

Coronary artery bypass grafting (CABG) in patients with immune thrombocytopenia (ITP): a community hospital experience and review of the literature.

We reviewed the records of 51 patients with Immune Thrombocytopenia (ITP) who underwent Coronary Artery Bypass Grafting (CABG) at Charleston Area Medical Center between June 1992 and September 2005. There were 41 males and 10 females with a median age of 68 years (range 49-87). Four patients had a previous splenectomy, one of whom had it performed concomitantly with the CABG. Three patients were on chronic corticosteroids on admission. The median pump time was 114 minutes (range: 42-244 minutes). The median cross-clamp time was 62 minutes (range 22-192 minutes). The median total chest tube drainage postoperatively was 1,346 cc (range: 265-9875cc). The mean preoperative and 24 hour postoperative platelet count was 126,000 (range 58,000-323,000) and 99,000/mm3 (range: 27,000-194,000), respectively. Twenty-one (40%) patients received platelet transfusions. Platelets were given intraoperatively or postoperatively in all but two of those patients. The median number of units of platelets given was 10 (range: 6-52). Twenty-seven (53%) received packed red cells intraoperatively or postoperatively. The median number of red cells given was 2 (range: 1-34). Other hemostatic agents given intraoperatively/ postoperatively included aprotinin (8 patients), aminocaproic acid (10 patients), DDAVP (5 patients), and intravenous gammaglobulin (IgG) in 3 patients. Thirteen patients were given corticosteroids preoperatively with little improvement in platelet count. CABG may be successfully performed in ITP patients with moderate thrombocytopenia (> or = 50,000/mm3) using conventional therapies (e.g., transfusions, IV IgG, hematinics) without the need for preoperative splenectomy or prolongation of hospital stay. However, a prospective study on the ideal management of ITP patients undergoing CABG would be beneficial.

Early clinical outcomes for 3 radiation techniques for brain metastases: focal versus whole-brain.

PURPOSE: To present our novel technique for brain metastases (low-dose whole brain radiation therapy [WBRT] with simultaneous integrated boost (SIB) and focal, frameless stereotactic intensity modulated radiotherapy [IMRT]) in the context of patterns of failure, dosimetry, acute toxicity, and overall survival for 3 different radiation techniques. METHODS AND MATERIALS: We retrospectively reviewed 92 patients undergoing radiation for brain metastases via the following: (1) "prophylactic" WBRT to a low dose (median 30 Gy) with an SIB to the gross tumor volume plus 2-3 mm margin (median dose 45 Gy) in 10-15 fractions; (2) focal, frameless image-guided stereotactic IMRT (S-IMRT) in 5 fractions to tumor only (median 30 Gy); or (3) conventional (c)WBRT using 2 lateral opposed beams in 10-15 fractions (30-37.5 Gy). The primary endpoints were local (LBC), distant (DBC), and total brain control (TBC) for each of the 3 types of brain radiation. Survival, toxicity, and dosimetry were reported as secondary endpoints. RESULTS: LBC was achieved in 72%, 78%, and 56% for SIB, S-IMRT, and cWBRT, respectively. DBC (ie, no new brain metastases) was observed in 92%, 67%, and 81% for SIB, S-IMRT, and cWBRT, respectively. TBC (LBC + DBC) was 72%, 67%, and 56% for SIB, S-IMRT, and cWBRT, respectively. No statistical difference in overall survival was observed (P = .067), and only 1 patient experienced biopsy proven radionecrosis. CONCLUSIONS: TBC after low-dose WBRT with SIB was acceptable and at least comparable to S-IMRT and cWBRT. SIB seems to be a safe and effective treatment strategy for patients with brain metastases and may efficiently combine the benefits of cWBRT and stereotactic radiosurgery.

Viral gastroenteritis in Charleston, West Virginia, in 2007: from birth to 99 years of age.

OBJECTIVE: To describe factors associated with a rectal swab or stool sample positive for norovirus, rotavirus, or adenovirus. DESIGN: Retrospective study. SETTING: Charleston Area Medical Center, a regional academic medical center in Charleston, West Virginia. METHODS: Rectal swab or stool samples were obtained from patients suspected of having viral gastroenteritis. These samples were sent to the Charleston Area Medical Center virology laboratory for testing in 2007. Viral antigen in rectal swab and stool samples is detected by use of commercially available immunoassay kits for each virus. Data were extracted from the virology laboratory database for the following 1-year time period: January 1, 2007, through December 31, 2007. When necessary, additional information was obtained from electronic administrative data on patients. RESULTS: There were 2,867 rectal swab and stool samples available for viral testing. Of these samples, 1,261 (44%) were positive for a virus. Of these positive samples, 972 (77%) were positive for norovirus, 182 (14%) were positive for rotavirus, and 110 (9%) were positive for adenovirus. The patients in the youngest age group had the highest number of test results positive for all 3 viruses. When the test results for the youngest age group (0-9 years) were compared with those for all the other age groups combined (10-99 years), the proportion of positive cases was highest for the youngest age group (P<.001). There were significant seasonal trends for all 3 viruses. Multivariate analysis of norovirus showed that season, source, sex, and age were significant predictors of a positive test result. Multivariate analysis of rotavirus showed that season and source were significant predictors of a positive test result. Multivariate analysis of adenovirus showed that season and age were significant predictors of a positive test result. CONCLUSIONS: We conclude (1) that these 3 viruses are common causes of gastroenteritis in Charleston, West Virginia; (2) that infants and young children are more likely to test positive for these viruses than are older individuals; (3) that norovirus was the most common cause of gastroenteritis; and (4) that there are seasonal trends for all 3 viruses.

Use of radiation after breast conserving surgery (BCS) for DCIS and early invasive breast cancer at Charleston Area Medical Center (CAMC). A study of compliance with National Comprehensive Cancer Network (NCCN) guidelines.

The National Comprehensive Cancer Network (NCCN) recommends that patients with ductal carcinoma in situ (DCIS) and stage I/II invasive breast cancer receive radiation therapy following breast conserving surgery (BCS). The purpose for our study was to determine 1) the percentage of patients with DCIS and stage I/II breast cancer who received radiation therapy following BCS and 2) the clinical factors associated with the use of radiation. We retrospectively studied 606 patients treated between 2000 and 2007 with BCS for DCIS (n=104) and stage I/II breast cancer (n=502). Overall 93 percent of patients in our study received radiation therapy. We found that almost 85 percent and 95 percent of patients with DCIS and stage I/II breast cancer respectively received radiation therapy. Patients with invasive breast cancer who were less than 70 years of age and who received adjuvant systemic therapy were significantly more likely to receive radiation. The data from our study indicate that the use of radiation following BCS is high at our institution. Periodic review of treatment practices at local hospitals is valuable in assessing compliance with national guidelines and in improving quality of care.

Gastrointestinal norovirus in the Charleston, West Virginia area-2007: birth to 99 years of age.

Data were collected on all patients in the Charleston, WV area tested for norovirus gastroenteritis during 2007. Of the 2687 rectal swab/stool samples, 60% were from individuals <20 years of age. Stool samples were more likely to be positive compared with rectal swab samples and if obtained from January to July and from patients <5 years of age.

Does sex make a difference in survival of patients undergoing resection for early stage non-small cell lung cancer (NSCLC)?

OBJECTIVE: To determine if sex associated differences exist in presentation and survival of patients undergoing resection for early stage nonsmall cell lung cancer (NSCLC). PATIENTS AND METHODS: Retrospective review of 2207 patients with Surveillance, Epidemiology, and End Results (SEER) Summary Stage I, II or III (local or regional disease) patients eligible for surgery, nonsmall cell lung cancer diagnosed and treated in WV between 1993 and 2000, which underwent surgery as a first course of treatment. Data set obtained from the West Virginia Cancer Registry. RESULTS: 1332 male cases and 875 female cases were reviewed. No statistically significant difference was found with mean age of diagnosis (men 66.5 years; women 67.2 years). A greater proportion of women had adenocarcinoma (p < 0.0001), lower grade (p = 0.002), and lower SEER summary stage (p = 0.009). There was no difference in laterality of tumor, 30-day post surgery survival or surgical procedure between men and women. Regression analysis showed a higher hazard ratio was associated with a increasing stage, grade, and those > or =65 years of age while lower hazard ratio was associated with adenocarcinoma. CONCLUSIONS: This study found that stage, grade, age, and histology, but not sex was the significant prognostic indicators of death in five years.

Gastrointestinal norovirus infection associated with exacerbation of inflammatory bowel disease.

OBJECTIVE: In this study we aimed to determine, in pediatric patients, whether norovirus infection could be associated with exacerbations of inflammatory bowel disease (IBD) and ascertain whether the clinical expression of norovirus gastroenteritis was similar in patients with IBD compared with non-IBD controls. MATERIALS AND METHODS: We performed a case-control retrospective chart review, over a 10-month interval, of patients with IBD with an exacerbation of their disease. The presence of norovirus in stool and/or rectal swab samples, as determined by an enzyme-linked immunoassay, was assessed. In addition, sex, age, type of IBD, presence or absence of diarrhea, hematochezia, and the need for hospitalization were determined. A similar number of control patients who did not have IBD were used as controls. RESULTS: Nine patients with IBD (8 ulcerative colitis/1 Crohn disease) had exacerbations with diarrhea. Eight had norovirus antigen in at least 1 sample. All 9 patients with IBD presented with bloody diarrhea and 6 of the 8 norovirus-positive patients with IBD required hospitalization. All of the control patients experienced diarrhea; however, no hematochezia was noted and no hospitalization was required. Several patients with IBD and controls remained positive for norovirus months after the initial positive stool and/or rectal swab sample. The virus appeared to be more common during winter months. CONCLUSIONS: We conclude that norovirus may be associated with exacerbations of IBD. When norovirus accompanies IBD it is more likely to be associated with hematochezia than when the infection occurs in the absence of IBD.

Natural history of carotid artery occlusion contralateral to carotid endarterectomy.

BACKGROUND: The natural history of patients with carotid artery occlusion is controversial. A few studies have concluded that patients with internal carotid artery occlusion carry a high risk of neurologic events. None of these previously reported studies analyze the natural history of internal artery occlusion contralateral to carotid endarterectomy (CEA), except for a small series including a subset of patients from two randomized trials, the Asymptomatic Carotid Atherosclerosis Study and the North American Symptomatic Carotid Endarterectomy Trial. This study analyzes the natural history of patients with carotid artery occlusion contralateral to CEA, specifically assessing long-term neurologic events occurring in the hemisphere associated with the occluded carotid artery. METHODS: Of the 599 CEAs in 544 patients that were included in two previously updated prospective studies, 63 patients had contralateral internal carotid artery occlusion, and their perioperative and long-term outcomes were evaluated. A Kaplan-Meier analysis was used to estimate the rate of freedom from late stroke occurring in the hemisphere ipsilateral to the occluded carotid artery. The stroke-free survival rate was also noted. RESULTS: Mean follow-up was 58 months (range, 1 to 147 months). One perioperative stroke (1.6%) occurred, which was not in the cerebral hemisphere ipsilateral to the occluded carotid artery. Two late strokes (3.2%) and nine transient ischemic attacks (TIAs) (14.3%) occurred involving the hemisphere of the occluded carotid artery. There were also three late TIAs (4.8%) and no late strokes involving the hemisphere supplied by the operative site. There were a total of 14 late deaths. Fifteen patients had late > or =50% restenosis of the operative side. Six of these had neurologic events (TIA/stroke) involving the hemisphere of the occluded carotid artery, in contrast to five of 48 patients with no restenosis who had neurologic symptoms (P < .001). Freedom from late strokes in the hemisphere ipsilateral to the occluded carotid artery at 1, 3, 5, and 10 years was 98%, 96%, 96%, and 96%, respectively. The stroke-free survival rates at 1, 3, 5, and 10 years were 90%, 87%, 80%, and 59%, respectively. CONCLUSIONS: The natural history of carotid artery occlusion contralateral to CEA is relatively benign. This may suggest a protective effect of carotid endarterectomy on the cerebral hemisphere ipsilateral to the carotid occlusion from late strokes.

Cost-effectiveness strategies to treat osteoporosis in elderly women.

BACKGROUND: Comparing the cost-effectiveness of various antiosteoporotic drugs has not been defined. METHODS: We determined the cost-effectiveness of calcitonin, raloxifene, bisphosphates and PTH in a base-case cohort of women aged 65 or older with osteoporosis. After bone densitometry, women were stratified into groups of treatment or no treatment. Our outcome goal was a value of dollars 100,000 or less per quality-adjusted life years (QALY). A sensitivity analysis varied nonvertebral fracture reduction and compliance between the two most effective strategies to test various cost per QALY thresholds. RESULTS: Bisphosphonates displayed the most favorable incremental cost saving and prevented more fractures in our base-case analysis. In a sensitivity analysis, virtually all values of bisphosphonates were under dollars 100,000 per QALY and parathyroid hormone (PTH) was between dollars 100,000 and dollars 200,000 per QALY. CONCLUSIONS: Only bisphosphonates are cost-effective for fracture prevention in osteoporotic women aged 65 or older and this economic advantage is also maintained in subsets who have a lower relative risk of future fracture.

Computed tomography versus color duplex ultrasound for surveillance of abdominal aortic stent-grafts.

PURPOSE: To compare the ability of computed tomography (CT) and color duplex ultrasound (CDUS) to detect endoleak and accurately measure aortic aneurysm diameters after endovascular repair. METHODS: Between February 2000 and October 2004, 178 consecutive patients (156 men; mean age 74 years, range 49-89) were treated with aortic stent-grafts (86 Ancure, 55 AneuRx, and 37 Excluder). The follow-up protocol included serial CT and CDUS at 1 month and every 6 months thereafter. Sensitivity, specificity, positive predictive value, negative predictive value, and Kappa statistics (kappa) were calculated using CT as the gold standard; Bland-Altman analysis was used to determine the 95% limits of agreement. Paired and unpaired t tests and correlation coefficients were used to compare the methods. RESULTS: Follow-up ranged from 1 to 53 months (mean 16), during which 367 paired CT and CDUS studies were acquired. The mean diameter of the AAA sac after repair was 5.15 cm by CT versus 4.99 cm by CDUS (p=0.07); 93% of paired studies were somewhat similar (

Prospective study of carotid endarterectomy with modified polytetrafluoroethylene (ACUSEAL) patching: early and late results.

OBJECTIVE: Carotid endarterectomies (CEAs) with standard polytetrafluoroethylene (PTFE) patching have been shown to have results comparable with those of autogenous vein patching; however, prolonged bleeding through needle holes in PTFE is a commonly recognized problem. This is the first study of CEA using a new hemostatic modified PTFE patch (GORE-TEX) analyzing the early and late outcomes. METHODS: Two hundred consecutive CEAs were entered into this protocol. All patients had an immediate postoperative carotid duplex ultrasound scan that was repeated at 1 month and every 6 to 12 months thereafter. A Kaplan-Meier analysis was used to estimate the stroke-free survival and the risk of restenosis. The mean follow-up was 21 months (range, 1 to 48 months). RESULTS: The perioperative stroke rate was 1.5% (1% ipsilateral and 0.5% contralateral, two minor strokes and one major stroke) with no perioperative mortality or perioperative carotid thrombosis. The incidence of perioperative transient ischemic attacks was 3.5% (2.5% ipsilateral and 1% contralateral). The mean hemostasis time after completion of the patching was 3 minutes, in contrast to 14 minutes for conventional PTFE (in a previous study). The rates of freedom from ipsilateral strokes at 1, 2, 3, and 4 years were 99%, 99%, 99%, and 99%, respectively. The cumulative stroke-free survival rates at 1, 2, 3, and 4 years were 98%, 96%, 93%, and 93%, respectively. The rates of freedom from > or =70% restenosis at 1, 2, 3, and 4 years were 97%, 97%, 94%, and 94%, respectively. CONCLUSIONS: CEAs with a new modified PTFE patch are safe, have low perioperative stroke rates, are durable, and have an acceptable hemostasis time.