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Biomedical subjects

E P Wilson

Publications and source records attributed to E P Wilson.

At least 19 recordsLinked to original sources

Toxic cure: Hyperfractionated radiotherapy with concurrent cisplatin and fluorouracil for Stage III and IVA head-and-neck cancer in the community.

PURPOSE: To evaluate efficacy and toxicity of the Duke University chemoirradiation regimen for locally advanced head-and-neck cancer in a regional community cancer center. METHODS AND MATERIALS: Between June 1998 and June 2002, 50 patients with Stage III or IVA squamous cell carcinoma of the head and neck were treated definitively with concurrent combined modality therapy (CMT). Patients received accelerated, hyperfractionated radiotherapy (AFRT), 1.2-1.25 Gy b.i.d., to a median prescribed dose of 70 Gy. Chemotherapy consisted of cisplatin 12 mg and fluorouracil 600 mg/m(2) daily for 5 consecutive days during Weeks 1 and 6, followed by two cycles after AFRT. Patients with N2-N3 neck disease (n = 21; 42%) were considered for neck dissection depending on their response to AFRT and chemotherapy. Twenty-nine patients with Stage III and IVA disease treated between 1991 and 1997 with definitive RT alone served as historical controls. RESULTS: Forty-nine patients (98%) in the CMT group completed the prescribed AFRT and 38 (76%) completed four cycles of chemotherapy. Three of 8 patients who underwent neck dissection had a pathologically complete response. The median follow-up for all patients was 23 months. The actuarial progression-free survival rate at 2 years was 75% for the CMT group vs. 40% (p <0.01) for the RT group. The overall survival rate was 80% and 43% (p <0.01), respectively, for the CMT and RT groups. Acute Radiation Therapy Oncology Group Grade 3 toxicities for the CMT group were mucosal (n = 50; 100%), skin (n = 9; 18%), and hematologic (n = 3; 6%). Late Grade 3-4 toxicities consisted of pharyngeal stricture (n = 7; 14%), laryngeal chondritis (n = 3; 6%), osteoradionecrosis (n = 2; 4%), and peripheral neuropathy (n = 1; 2%). CONCLUSION: This aggressive regimen of AFRT with concurrent cisplatin and fluorouracil with or without neck dissection is feasible in the community setting for patients with Stage III and IVA head-and-neck cancer. Early results indicated excellent survival, albeit with universal acute mucosal, and considerable, although acceptable, late toxicity.

Antineoplastic Combined Chemotherapy Protocols↗

Update on the Talent aortic stent-graft: a preliminary report from United States phase I and II trials.

PURPOSE: Phase I and phase II trials were conducted to determine the safety and efficacy of the Talent aortic stent-graft (Medtronic World Medical, Sunrise, Fla) in the treatment of infrarenal abdominal aortic aneurysms (AAA). This is a preliminary report of the technical results and 30-day clinical outcome of these trials. METHODS: Multicenter prospective trials were conducted to test the Talent stent-graft in high-risk and low-risk patient populations with AAA, including phase I feasibility and phase II clinical trials. The low-risk study included concurrent surgical controls. RESULTS: In the phase I trial, deployment success was achieved in 92% (23/25 patients), and initial technical success was 78% (18/23 implants without endoleak). The 30-day technical success rate was 96%, with six endoleaks that resolved spontaneously (without need for further intervention); and the 30-day mortality rate was 12% (3/25 patients). The phase II high-risk trial demonstrated a deployment success of 94% (119/127 patients) and an initial technical success of 86% (102/119 implants). The 30-day technical success rate was 96%, and the 30-day mortality rate was 1.5% (2/127 patients). The phase II low-risk trial included a first-generation and a second-generation Talent stent-graft. Deployment success rates were 97% and 99%, respectively, and technical success rates at 30 days were 97% and 96%, respectively. The 30-day mortality rate was 2% in the phase II low-risk first-generation device trial, and the adverse-event rate was 20%. Corresponding figures for the second-generation device were 0% and 1.8%, respectively. CONCLUSION: The Talent stent-graft can be deployed successfully and achieves endovascular exclusion in a large proportion of patients with AAA. Morbidity and mortality rates are acceptable. One-year clinical results and the comparison with concurrent surgical control subjects remain to be evaluated.

Angioplasty↗

Squamous cell carcinoma of the anterior nasal cavity: a dual institution review.

Thirty-two patients with squamous cell carcinoma of the anterior nasal cavity were identified at two university hospitals. A retrospective review was conducted to identify clinical presentation, initial therapy, recurrence rates, and factors affecting survival. Treatment included surgery (n = 15), radiation therapy (n = 9), or combination therapy (n = 8). The primary lesions involved either the septum, vestibule, columella, anterior floor, or a combination of these subsites. The primary tumor involved a single nasal subsite in 22 patients and multiple nasal subsites in 10 patients. All patients had de novo squamous lesions, and all tumors were staged N0 at initial diagnosis. Six patients received prophylactic neck irradiation, and none underwent elective neck dissection. Overall, 18 (56%) patients had recurrent disease after primary therapy (5 local and 13 regional). The 5-year disease-free survival was 42%, and the 5-year overall survival was 50%. None of the patients receiving prophylactic neck irradiation had a regional recurrence. Involvement of 2 or more nasal subsites significantly decreased survival (P < 0.05). Squamous cell carcinoma of the anterior nasal cavity is an aggressive disease, and combined therapy initially with strong consideration for prophylactic radiation to the facial and cervical lymphatics is advocated.

Aged↗

Brachial artery catheterization to facilitate endovascular grafting of abdominal aortic aneurysm: safety and rationale.

PURPOSE: Endovascular treatment of abdominal aortic aneurysms (AAAs) is a technically demanding procedure that is based on the complexity and multiplicity of steps and the guidewire and catheter manipulations required. Brachial artery catheterization is an adjunctive technique that can facilitate the placement of an endoluminal prosthesis. METHODS: Brachial access was used during endoluminal AAA repair in 79 of 103 consecutive patients with a modular-design stent-graft prosthesis at two institutions. RESULTS: Left brachial access facilitated (1) angiography to guide juxtarenal device deployment, (2) antegrade contralateral limb access, (3) device delivery through disadvantaged iliac arteries by means of a brachial femoral wire, (4) access to renal arteries when necessary, and (5) catheter exchanges and a reduction in fluoroscopic positional changes. Complications included one puncture-site pseudoaneurysm, seven hematomas, and 29 patients with extensive ecchymosis. The length of stay was not prolonged in any case. There were no embolic, oculocerebral, or ischemic upper extremity events. CONCLUSIONS: Brachial artery catheterization, as an adjunctive technique to endoluminal AAA repair, offers noteworthy technical advantages with few, but self-limiting complications.

Angiography↗

Safety of coil embolization of the internal iliac artery in endovascular grafting of abdominal aortic aneurysms.

PURPOSE: During endovascular grafting of an abdominal aortic aneurysm (AAA), iliac limb extension to the external iliac artery may be indicated when the common iliac artery is ectatic or aneurysmal. Preliminary or concomitant coil embolization of the internal iliac artery (IIA) is thus necessary to prevent potential reflux and endoleak. We sought to determine the safety of hypogastric flow interruption in this setting. METHODS: We retrospectively reviewed 156 patients who underwent stent-graft AAA repair at two institutions between February 1, 1998, and January 31, 1999. Coil embolization of one or both IIAs was undertaken when the diameter of the common iliac artery was more than 20 mm to enable limb endograft extension to the external iliac artery. Bilateral procedures were staged. RESULTS: Thirty-nine (25%) of 156 patients were selected for coil embolization of one (n = 28) or both (n = 11) IIAs. The interventions were performed before (n = 31) or during (n = 8) the stent-graft procedure. Complications included groin hematomas in 3 patients, iliac artery dissection in 1, failure to catheterize the IIA in 2, and transient rise in the serum creatinine level in 3. One patient had erectile dysfunction, and five patients (13%) had buttock claudication after unilateral occlusion. Serious ischemic complications were not observed. CONCLUSION: Coil embolization of one or both IIAs appears to be safe in the setting of endovascular grafting of AAA. Buttock claudication is a relatively significant problem and may limit applicability of this strategy to patients who are unfit for standard open repair.

Aged↗

Single-incision technique for internal fixation of distal tibia and fibula fractures.

Open reduction and internal fixation of distal tibia and fibula fractures generally involves two separate incisions: an anteromedial incision to approach the tibia and a lateral incision to approach the fibula. Exposing the distal tibia from the medial side is associated with the risk of wound dehiscence, infection, and discomfort to the patient since the hardware is directly beneath the skin. By using a single incision from the anterolateral side, the fibular fracture can be fixed and the lateral aspect of the distal tibia can be safely approached for internal fixation, thus eliminating the need for two separate incisions.

Female↗

Intravascular ultrasound.

Vascular anatomy can be more accurately assessed from an endoluminal position applying the principles of conventional ultrasound. It may effectively batter select patients for endovascular procedures and complement the information gained from CT, MRA, transcutaneous ultrasound, and contrast angiography. Three-dimensional and longitudinal grey-scale reconstruction of tomographic IVUS images are made available through computer software programs. Information gained includes: plaque characterization and morphology, a cross-sectional evaluation of stenoses, assessment of the impact/effect of balloon angioplasty, evaluation of vessel dissections and the ability to selectively place intravascular stents.

Angiography↗

The effect of angulation on intravascular ultrasound imaging observed in vascular phantoms.

PURPOSE: To quantify the error introduced by noncoaxial intravascular ultrasound (IVUS) imaging and to evaluate the use of a balloon-tipped catheter in compensating for intraluminal angulation and subsequent dimensional inaccuracy. METHODS: The effect of noncoaxial IVUS imaging was investigated in both a polyvinyl chloride phantom and an in vitro canine aorta using a calibrated setup to measure angulation off axis. Imaging was performed at increasing angulation (creating an elliptical image) in both phantoms, with the transducer centered and off center. Diameters were compared to the original coaxial diameter, as well as calculated diameters based on specific angles off axis. The percentage change (error) was also calculated at these angles. The measurements were repeated using a balloon-tipped catheter to center the transducer. RESULTS: The measured diameters and percentage changes compared closely with their calculated counterpart. Up to 25 degrees off axis, the apparent increase in diameter measurement was nearly 10%. Angulation from 30 degrees to 70 degrees resulted in an increase of 15% to 192%. Use of the centering balloon reduced the amount of error by 70% to 85% but was limited to angles < or = 25 degrees due to the design of the test apparatus. CONCLUSIONS: The error introduced by noncoaxial IVUS imaging can be significant and may be partially corrected by the use of a centering balloon. Further studies in the clinical application of a centering device are warranted.

Animals↗

Deployment and healing of an ePTFE encapsulated stent endograft in the canine aorta.

This study evaluated deployment mechanics and long-term healing of an endoluminally placed stent/graft in normal canine aortas. The endoluminal graft (ELG) consisted of a 8.5 cm segment of expanded polytetrafluoroethylene (ePTFE) graft material (Impra, Inc., Tempe, AZ) encapsulating a series of six Palmaz P-128 stents (Johnson & Johnson Interventional Incorporated, New Brunswick, NJ) along the length of the graft. The prostheses were deployed via the femoral artery using a 14Fr delivery system that contained a balloon catheter to expand the ELG in the infrarenal aorta. Twenty-one prostheses were deployed and evaluated at 1 week (n = 3), 1 month (n = 3), 3 months (n = 3), 6 months (n = 9), and 1 year (n = 3). Dimensions of the infrarenal aorta were determined with intravascular ultrasound (IVUS) and angiography prior to deployment of devices. Real-time fluoroscopy and IVUS were used to monitor device deployment with both imaging modalities repeated following implantation. Gross inspection and microscopic evaluation was performed on the explanted specimens following in vivo evaluation by CT scan, IVUS, and angiography prior to retrieval of the specimens. The prostheses were easily deployed from the femoral access site. Oversizing of the deployment balloon compared to the aortic diameter was necessary to accommodate the 10% device recoil observed following balloon deflation, however, all devices were seated against the aortic wall as evidenced by IVUS. At explant, all devices ware widely patent with limited luminal thrombosis observed in four specimens (19%). Devices were well-incorporated by cellular ingrowth into the ePTFE with the formation of neointima. No device migration or postdeployment recoil was observed. ePTFE graft material between stents protruded slightly into the vessel lumen accounting for a 10% luminal reduction. Fully supported ELG's consisting of balloon expandable stents encapsulated in ePTFE are easily deployed using a low-profile delivery system. Specimens demonstrated uniform long-term patency and healing up to 1 year in a canine aortic model. Those preliminary findings support further study of this fully supported prosthesis in the treatment of arterial disease.

Angioplasty, Balloon↗

Regression of an abdominal aortic aneurysm after endograft exclusion.

We describe the regression of a 6.5 cm diameter abdominal aortic aneurysm in a 71-year-old patient within 1 year of aortic endograft placement. The aneurysm decreased in size to 4 cm at 3 months and was 3.3 cm at 8 months on duplex examination. By 1 year a spiral computed tomographic study confirmed complete regression of the aneurysm, with mild shortening and angulation of the unsupported body of the aortoiliac endoluminal prosthesis. The case demonstrates a potential of endograft treatment of aortic aneurysms and decribes the changes in prosthesis configuration and position that occurred after implantation.

Aged↗

Preliminary clinical outcome and imaging criterion for endovascular prosthesis development in high-risk patients who have aortoiliac and traumatic arterial lesions.

PURPOSE: This report reviews our preliminary experience of prospective treatment of arterial lesions with endoluminal grafts in a Food and Drug Administration (FDA)-approved, investigator-sponsored Investigation Device Exemptions study. The utility and accuracy of various imaging methods, including angiography, cinefluoroscopy, computed tomography (CT), intravascular ultrasonography (IVUS), and duplex scanning, in performing the procedures was also assessed. METHODS: Thirty-one patients were evaluated; 17 patients were treated, including 11 with abdominal aortic aneurysms, one with an aortic occlusive lesion, two with iliac artery aneurysms, and three with traumatic arteriovenous fistulas. Twelve of the 14 patients who had aorta and iliac artery lesions were high-risk. The mean follow-up of patients treated was 9 months (range, 6 to 15 months). RESULTS: Aortoaortic endoluminal interposition procedures were not successful for treating abdominal aortic aneurysms early in the study (n = 3). Aortoiliac endoluminal bypass, contralateral iliac artery occlusion, and femorofemoral bypass procedures were successful in seven of eight subsequent cases (88%), with no incidence of endoleaks at either the proximal or distal fixation sites using the deployment methods described in this report. The 30-day operative mortality rate on follow-up evaluations for patients who underwent aortoiliac procedures was 14% (two of 14). Other major complications included transient renal failure in three patients that required short-term (two to eight times) dialysis, one arterial perforation and one dissection, and one prolonged intubation. No myocardial infarctions or strokes occurred. After major complications or identification of limitations in the study, the protocol was modified with the approval of the FDA to help avoid the recurrence of the same problems. There were no deaths or complications in the trauma cases. CONCLUSIONS: Contrast-enhanced CT (axial images and spiral reconstructions) was the most accurate method to determine candidacy for aortoiliac procedures and to choose the site for deployment of the devices. Angiographic scans were misleading in several patients regarding the critical determinants of patient candidacy and device deployment, particularly regarding the presence of a distal aortic neck. Cinefluoroscopy was used in all patient and was particularly useful for determining the continuity of vascular structures and the anatomy of branch arteries and for enabling precise positioning of stent devices. Determination of fixation sites and assessing dimensional information by cinefluoroscopy and angiography were limited by inaccuracies produced by image magnification, parallax, and uniplanar views. IVUS was used to determine the morphologic features of vascular structures (i.e., calcium, thrombus), to perform real-time observation of the expansion of devices, and to assure firm fixation of balloon-expanded stents before the procedures were completed. Duplex scanning was very helpful in assessing and identifying precisely the location of arteriovenous fistulas before intervention and provided assessment at follow-up intervals. Three-dimensional reconstruction imaging technologies such as spiral CT were particularly helpful for assessing the morphologic features of vascular anatomy before the intervention and at follow-up intervals, whereas 3-D IVUS provided a similar real-time perspective during the procedure.

Aged↗