Biomedical subjects

Bruce J Brener

Publications and source records attributed to Bruce J Brener.

4 recordsLinked to original sources

PubMed2002

An in situ adjustable endovascular graft for the treatment of abdominal aortic aneurysms.

Twenty-nine patients underwent placement of the Teramed Ariba Endovascular Graft System (Maple Grove, Minn) as part of a European Feasibility study (14 patients) and a US phase I trial (15 patients). Salient features of this modular endograft system include a crimped seamless polyester bifurcation graft supplied in three diameters and three iliac limb lengths, three types of nitinol stents including a suprarenal stent with aortic barbs, a flexible delivery system capable of controlled incremental sheath retraction, a flexible tapered lead balloon, and a telescoping technique for adjusting the length of graft coverage during surgery over a range of 3 cm. Twenty-eight of the 29 patients met the primary objective of this evaluation, which was to confirm the safety of the system, defined as the absence of major device-related adverse events and type I, III, or IV endoleaks within 1 month of implantation. Three major adverse events occurred within 1 month of discharge: renal failure, which was related to deployment of the device close to the renal arteries; pulmonary edema, which was related to the procedure but not the device; and peripheral ischemia, which was related to the patient's pre-existing condition. Seven patients had type II endoleaks noted by means of computed tomography scanning at 1 month; the endoleaks were identified by means of angiography and classified at the time of surgery. There were no deaths, aneurysm ruptures, stent-graft migrations, stent fractures, graft ruptures, graft thromboses, or surgical conversions at 1 month. This early clinical experience indicates that the Ariba Bifurcated Endovascular System can be safely implanted.

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PubMed2002

A multicenter experience with the Talent endovascular graft for the treatment of abdominal aortic aneurysms.

OBJECTIVE: The Talent endovascular graft has been used in the treatment of abdominal aortic aneurysms (AAAs) in more than 13,000 patients worldwide. However, information regarding the results of its use has been limited. This report describes the experience with 368 patients with AAAs who underwent treatment at four medical centers as part of an investigator-sponsored investigational device exemption trial. METHODS: Patients with AAAs were enrolled at four sites during a 32-month period from January 1999 to July 2001. All patients underwent treatment for infrarenal AAA with the Talent endovascular graft. Repair was performed with transrenal stent fixation under epidural (362/368 patients; 98.3%), local (4/368 patients; 1.1%), or general (2/368 patients; 0.5%) anesthesia. The average diameters were: maximum aortic aneurysm, 6.2 +/- 1.2 cm; proximal aortic fixation site, 2.6 +/- 0.4 cm; and distal iliac fixation site, 1.4 +/- 0.6 cm. Bifurcated grafts were used in 276 of 366 patients (75%), aortouniiliac in 57 of 366 patients (16%), and tube aortoaortic in 33 of 366 patients (9%). Multiple comorbid medical conditions were present in all patients (average, 4.7 conditions/patient). The mean age was 75.8 years, and 85% of the patients were male. Follow-up period ranged from 2 to 33 months (mean, 7.3 months). RESULTS: Endovascular graft deployment was accomplished in 366 of 368 patients. In the 263 patients followed for at least 6 months after endovascular repair, AAA diameter decreased by 5 mm or more in 83 patients (32%); diameter remained unchanged (change < 5 mm) in 157 patients (60%) and increased by 5 mm or more in 23 patients (8.7%). Major morbidity occurred in 46 of 368 patients (12.5%), and minor morbidity occurred in 31 of 368 (8.4%). The 30-day mortality rate was 1.9%. Secondary procedures were performed in 32 patients (8.7%). Late rupture occurred in two patients, and late deaths unrelated to AAA occurred in 32 patients (8.7%) during the follow-up period. The primary technical success rate for all patients was 93.4%. The 30-day primary procedural success rate was 73.3%. The 30-day secondary procedural success rate was significantly higher at 85.8%. Computed tomographic scan was performed within 1 month after surgery in 349 patients. An endoleak was present in 43 of 349 patients (12.3%). These endoleaks were comprised of 10 attachment site (type I; 2.9%), 31 retrograde side-branch (type II; 8.9%), and two transgraft (type III; 0.6%). CONCLUSION: These midterm findings show a high degree of technical and procedural success achieved in a patient population with extensive comorbid medical illnesses with low perioperative morbidity and mortality rates. Further follow-up study will be necessary to determine the effectiveness of the Talent endograft for the long-term treatment of AAA.

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PubMed2002

Regeneration.

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Humans↗

PubMedDate not supplied

Prophylactic antibiotics prior to bacteremia decrease endovascular graft infection in dogs.

Endovascular placement of vascular stent grafts in the aorta and peripheral vessels has become a prominent tool in the armamentaria of the vascular surgeon. Despite, several reports of stent graft infection, no current guidelines exist regarding the administration of antibiotics prior to episodes of potential bacterial seeding. We sought to clarify the role of prophylactic antibiotics in preventing stent graft infection after the parenteral administration of Staphylococcus aureus (S. aureus) at various intervals following device placement. A stent graft device was constructed from a 4 mm thin-walled polytetrafluoroethylene (PTFE) graft attached to the outside of a balloon expandable 394-Palmaz stent (Johnson and Johnson Interventional Systems, Warren, NJ). It was then inserted into the common iliac artery through an 11F peal-away sheath placed in the femoral artery. Sixty grafts were placed into 30 dogs. There were 5 groups of equal number (groups A-E). In group A, six dogs received intravenous injection of 3 cc x 104 CFU (colony forming units), biotype 31375 S. aureus, 1 day after stent graft implantation. An identically treated group B received antibiotic prophylaxis (1 gm cefazolin 30 minutes prior to bacterial challenge). Group C received bacterial injection 7 days after graft implantation with no antibiotic prophylaxis. Group D received bacterial injection 7 days after graft implantation with antibiotic prophylaxis. A control group E received no antibiotics and was not infected. All infected animals were sacrificed 7 days following bacterial challenge and the stent graft complex cultured. One half of the control group was sacrificed at 7 days and the other half at 14 days. The overall stent graft patency was 90%. Four of the six graft occlusions occurred in group A. Eleven of 12 (92%) dogs cultured S. aureus (biotype 31375) from the explanted stent graft complex. Two localized perforations occurred at the site of the infected complex. In group B, C, and D, no explanted graft complex cultured S. aureus. One graft occluded in group C and D. No stent graft in the control (group E) cultured S. aureus. A stent graft infection model can be consistently produced. In the canine model, the stent graft is more susceptible to infection in the early postoperative period and becomes less susceptible to bacterial seeding at one week after implantation. The authors recommend the use of prophylactic antibiotics in the prevention of endovascular graft infections in the early postoperative period during times when bacterial seeding may occur. They postulate that pseudointima formation during graft incorporation into the vessel wall may be responsible for the resistance to infection.

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