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Biomedical subjects

F J Veith

Publications and source records attributed to F J Veith.

At least 109 records · Page 6Linked to original sources

Thrombolysis or peripheral arterial surgery: phase I results. TOPAS Investigators.

PURPOSE: Thrombolytic therapy is widely used in the treatment of peripheral arterial occlusion, but prospective, randomized comparisons with standard therapy remain few. A multicenter trial of thrombolysis or peripheral arterial surgery (TOPAS) was organized to compare critically the use of recombinant urokinase (rUK) or surgery for the initial treatment of acute lower-extremity ischemia. Phase I of the trial was designed as a dose-ranging trial to evaluate the safety and efficacy of three doses of rUK in comparison with surgery. METHODS: In a multicenter, prospective, double-blind comparison, 213 patients who had acute lower-extremity ischemia for 14 days or fewer were randomized to one of two groups. The first group received one of three dosages of rUK (catheter-directed at 2000, 4000, or 6000 IU/min for 4 hours, then 2000 IU/min to a maximum of 48 hours). The second group underwent surgery. Successful thrombolysis was followed by surgical or endovascular interventions when anatomic lesions responsible for the occlusion were unmasked. Patients were followed-up for 1 year; data were evaluated on an intent-to-treat basis. RESULTS: The 4000 IU/min rUK dosage was chosen as the most appropriate thrombolytic regimen because it maximized lytic efficacy against the risk of bleeding. Complete (> 95%) lysis of thrombus was achieved in 71% of the 49 patients who were randomized to the 4000 IU/min group, with a mean infusion time of 23 hours. In contrast, complete lysis was achieved in 67% of patients who received 2000 IU/min and in 60% of patients who received 6000 IU/min. Hemorrhagic complications occurred in 2% of the 4000 IU/min group versus 13% of the 2000 IU/min group (p = 0.05) and 16% of the 6000 IU/min group (p = 0.03). In a comparison of the 4000 IU/min group with the surgical group, the 1-year mortality rate (14% vs 16%) or amputation-free survival rate (75% vs 65%) did not differ significantly. The frequency and magnitude of surgery in the patients randomized to rUK were decreased (p < 0.001). CONCLUSION: The preliminary results suggest that an initial rUK dose of 4000 IU/min is safe and efficacious in the treatment of acute lower-extremity ischemia. rUK therapy is associated with limb salvage and patient survival rates similar to those achieved with surgery, concurrent with a reduced requirement for complex surgery after thrombolytic intervention.

Acute Disease↗

Comparison of endovascular and conventional vascular prostheses in an experimental infection model.

INTRODUCTION: The causes and management of prosthetic graft infections have been extensively studied for conventional bypass grafts; however, the infectivity and therapy for endovascular graft infections are completely unknown. The aim of this study was to compare the biologic properties of infected aortic grafts when inserted by endoluminal or standard transabdominal techniques. METHODS: Eighteen dogs underwent placement of polytetrafluoroethylene grafts in their infrarenal aortas either by an endovascular technique (8) or a standard interposition technique (10). Endovascular grafts were constructed from polytetrafluoroethylene (3 cm) and two balloon-expandable stents coaxially mounted onto a balloon catheter delivery system. The grafts were inserted through a left carotid arteriotomy under fluoroscopic control. Initially, seven grafts were infected with decreasing inocula of Staphylococcus aureus, starting at 10(7) organisms per ml for 30 minutes and then rinsed briefly (10 seconds) in normal saline solution, until a 50% infective dose for the standard grafts was determined to be 10(2) organisms per ml. After this initial experiment, a second group of 11 dogs were compared at a concentration of 10(2) S. aureus per ml. Five dogs underwent endovascular repair, and six dogs had standard graft interpositions after an identical period of bacterial exposure. All grafts were removed at 2 weeks under sterile conditions and were submitted for quantitative culture analysis. RESULTS: Three of the six dogs (50%) with standard grafts appeared to clear their infections, whereas only one of the five dogs (20%) with an endovascular graft was free of organisms at 14 days. This results was further manifested by statistically significant lower postmortem colony counts in the standard grafts (p < 0.01). CONCLUSIONS: The endoluminal position of the graft and its proximity to the arterial wall do not appear to provide protection against infection. These data suggest that if endovascular grafts become infected, they may be in a disadvantaged position for host defense mechanisms to be effective.

Animals↗

Endovascular aortounifemoral grafts and femorofemoral bypass for bilateral limb-threatening ischemia.

PURPOSE: Although axillobifemoral bypass procedures have a lower mortality rate than aortobifemoral bypass procedures, they are limited by decreased patency, moderate hemodynamic improvement, and the need for general anesthesia. This report describes an alternative approach to bilateral aortoiliac occlusive disease using unilateral endovascular aortofemoral bypass procedures in combination with standard femorofemoral reconstructions. METHODS: Seven patients who had bilateral critical ischemia and tissue necrosis in association with severe comorbid medical illnesses underwent implantation of unilateral aortofemoral endovascular grafts, which were inserted into predilated, recanalized iliac arteries. The proximal end of the endovascular graft was fixed to the distal aorta or common iliac artery with a Palmaz stent. The distal end of the graft was suture-anastomosed to the ipsilateral patent outflow vessel, and a femorofemoral bypass procedure was then performed. RESULTS: All endovascular grafts were successfully inserted through five occluded and two diffusely stenotic iliac arteries under either local (1), epidural (5), or general anesthesia (1). The mean thigh pulse volume recording amplitudes increased from 9 +/- 3 mm to 30 +/- 7 mm and from 6 +/- 2 mm to 26 +/- 4 mm ipsilateral and contralateral to the aortofemoral graft insertion, respectively. In all cases the symptoms completely resolved. Procedural complications were limited to one local wound hematoma. No graft thromboses occurred during follow-up to 28 months (mean, 17 months). CONCLUSIONS: Endovascular iliac grafts in combination with standard femorofemoral bypass grafts may be an effective alternative to axillobifemoral bypass in high-risk patients who have diffuse aortoiliac occlusive disease, particularly when bilateral axillary-subclavian disease is present.

Aged↗

Immunolocalization and temporal distribution of cytokine expression during the development of vein graft intimal hyperplasia in an experimental model.

PURPOSE: Vein graft stenosis caused by intimal hyperplasia (IH) accounts for 30% to 50% of late bypass graft failures; however, the biochemical mediators of vein graft IH have been poorly defined. We attempted to evaluate the spatial and temporal distribution of five principal cytokines (interleukin-1 beta [IL-1 beta], platelet-derived growth factor-AA [PDGF-AA], basic fibroblast growth factor [bFGF], interferon gamma [INF gamma], and tumor necrosis factor alpha [TNF-alpha]) during the development of IH in a rat vein graft model. METHODS: Rat epigastric vein interposition grafts in the femoral artery were harvested at 6 hours, 2 days, 1 week, 2 weeks, and 4 weeks after the grafting procedure and studied with immunohistochemical and standard histologic techniques. The cytokine expression in the endothelium and media/neointima was quantified as the percentage of immunopositive cells per high-power field. RESULTS: Maximal hyperplasia occurred 2 weeks after the grafting procedure. Peak expression of IL-1 beta and bFGF occurred by 2 days. PDGF-AA expression paralleled the development of IH, peaking at 2 weeks and then declining. TNF-alpha expression increased at 1 week and remained elevated. INF gamma was seen only in control grafts. CONCLUSIONS: The coordinated early release of IL-1 beta and bFGF and the down-regulation of INF gamma seem to trigger an inflammatory response, thereby initiating IH. The process then is propagated by the release of PDGF-AA and TNF-alpha, with concomitant smooth muscle cell proliferation and production of extracellular matrix. It is likely that this complex milieu of local paracrine signaling is required to generate the hyperplastic response seen in failing vein grafts.

Actins↗

The merit of polytetrafluoroethylene extensions and interposition grafts to salvage failing infrainguinal vein bypasses.

PURPOSE: The purpose of this study was to evaluate the merit of polytetrafluoroethylene (PTFE) extensions and interpositions for the management of failing infrainguinal vein bypass grafts. METHODS: The treatment of 133 failing vein grafts in 125 patients over a 10-year period was retrospectively reviewed. Twenty-two graft-threatening lesions were detected in patients who did not have a usable autogenous vein conduit as determined by preoperative and intraoperative evaluations. A PTFE extension or interposition graft was used for the necessary reconstruction in all cases. RESULTS: Ten lesions were within the vein graft, 11 were proximal to the graft in the femoral or popliteal artery segments, and one was distal to the graft in the popliteal artery. The treatment of these lesions included 19 extensions and three mid graft interpositions. The vein graft lesions developed significantly sooner (mean 10.6+/-2.5 months) after the bypass (p<0.05) than the arterial lesions (mean 28.0+/-6.1 months). The 3-year cumulative secondary patency rate for these vein grafts treated with PTFE extensions or interpositions was 84%+/-8%. This was not significantly different from the 3-year cumulative secondary patency rate for vein grafts treated with vein extensions or interpositions at our institution over the same time period (82%+/-10%). The 3-year limb salvage rates were 95% and 89%, respectively. CONCLUSIONS: These results indicate that PTFE extensions and interpositions can be used successfully to maintain the patency of failing vein grafts and may serve to prolong limb salvage in patients without any usable autogenous vein. Early reintervention with a PTFE conduit in this difficult group of patients is appropriate to salvage a failing vein graft.

Aged↗

Polytetrafluoroethylene bypasses to infrapopliteal arteries without cuffs or patches: a better option than amputation in patients without autologous vein.

PURPOSE: This study was undertaken to evaluate our results of polytetrafluoroethylene (PTFE) tibial and peroneal artery bypasses done for limb salvage. METHODS: Within a group of patients undergoing infrainguinal limb salvage bypasses at our institution between January 1986 and May 1995, 63 patients faced an immediate amputation, had no autologous vein on duplex examination and operative exploration, and had only a tibial or peroneal artery as an outflow vessel for bypass. Most of these patients (82%) had two or more prior ipsilateral infrainguinal bypasses. These 63 patients underwent 66 PTFE bypasses to a tibial or peroneal artery without a distal anastomotic vein cuff or an adjunctive arteriovenous fistula. Our results were then compared with those reported from infrapopliteal (crural) bypasses performed with alternate autologous vein sources or PTFE in conjunction with various recommended adjuncts. RESULTS: The 3- and 5-year cumulative primary graft patency rates for our PTFE infrapopliteal bypasses were 39%+/-7% and 28%+/-9%, respectively. Secondary graft patency rates were 55%+/-8% and 43%+/-10% at 3 and 5 years, respectively. Limb salvage rates were 71%+/-7% at 3 years and 66%+/-8% at 5 years. Two-year actuarial patient survival rate was only 67%+/-7%. CONCLUSIONS: These results indicate that a PTFE bypass to an infrapopliteal artery remains a worthwhile option in patients without usable autologous vein. The secondary patency and limb salvage rates were acceptable in this setting and were not significantly different from the best results reported with prosthetic tibial/peroneal bypasses with distal vein cuffs or patches (74% at 1 year; 58% at 3 years), arteriovenous fistulas (71% at 1 year) or composite arm vein grafts (39% and 29% at 3 and 5 years, respectively).

Actuarial Analysis↗

Endovascular graft repair of penetrating subclavian artery injuries.

PURPOSE: Penetrating subclavian arterial injuries are often difficult to treat. Standard surgical techniques require wide exposure and dissection in traumatized areas, which is often challenging. This report summarizes the early results of endovascularly placed stented grafts for the treatment of penetrating subclavian arterial trauma. METHODS: Six patients with penetrating injuries of the subclavian artery had stented grafts inserted to repair five pseudoaneurysms and one arteriovenous fistula. The stented grafts consisted of a polytetrafluoroethylene graft sutured over a balloon-expandable Palmaz stent. The devices were inserted from an ipsilateral brachial arteriotomy and deployed using fluoroscopic guidance in the operating room. RESULTS: Immediate success was obtained in all procedures (100%). All patients continue to have patent grafts with a follow-up ranging from 7 to 30 months (mean 19 months). The only procedure-related complication was the need for a brachial artery patch angioplasty at the site of device insertion in the first patient. There was one other patient who developed a stent fracture at 8 months; a second stent was inserted. Duplex studies up to 24 months later show no recurrence in this patient. CONCLUSIONS: Endovascular stented grafts offer an effective, less invasive alternative to standard techniques in treating traumatic arterial lesions. Early results are encouraging, but long-term follow-up will be necessary to fully delineate the effectiveness of this technique.

Adult↗

Endovascular stents and stented grafts for the treatment of aneurysms and other arterial lesions.

The combination of prosthetic graft and intravascular stent technologies will probably become an important part of the treatment for aneurysmal and occlusive disease as well as for traumatic vascular injuries. This technology potentially permits reduced operative morbidity and mortality rates as well as decreased intraoperative blood loss, cost, and hospital stay, with ultimately improved patient care. Once additional experience with this important new technique has been obtained, randomized, prospective trials comparing standard therapy to endovascular grafting procedures will be needed to substantiate this form of therapy for the treatment of various arterial lesions.

Aneurysm↗

Transfemoral, endovascular stented graft repair of an abdominal aortic aneurysm.

Endovascular aortic graft implantation is a new procedure for the repair of arterial aneurysms. We report on the first such case successfully performed in the United States. A 76-year-old man with severe oxygen-dependent pulmonary insufficiency, coronary artery disease, and recurrent ventricular tachyrhythmia was also diagnosed as having a 7.5-cm infrarenal abdominal aortic aneurysm. Because of the high risks associated with conventional surgical repair, consent was obtained for compassionate use of an experimental device. Using local anesthesia, a 22-mm Dacron prosthesis was inserted under fluoroscopic guidance through an open, left transfemoral route. Completion arteriography demonstrated aneurysm exclusion. No blood transfusion was required and there were no perioperative complications. Further technical refinements and clinical trials will be required prior to the broad implementation of this technique.

Aged↗

Placement of endovascular stented grafts via remote access sites: a new approach to the treatment of failed aortoiliofemoral reconstructions.

Endovascular grafting is a technique that combines the use of intravascular stents and prosthetic grafts to fabricate devices with unique properties. The purpose of this study is to describe the use of endovascular graft technology in the treatment of failed or failing standard aortoiliofemoral reconstructions. Over a 15-month period five patients with limb-threatening ischemia and failed aortofemoral or iliofemoral reconstructions underwent successful placement of six endovascular grafts to revascularize seven severely ischemic lower extremities. Standard thin-walled 6 mm polytetrafluoroethylene grafts and Palmaz balloon-expandable stents were used to fashion each reconstruction. In addition to the primary endovascular grafts, three patients underwent immediate femoropopliteal bypasses to improve distal outflow and one patient had a femorofemoral bypass graft to restore circulation to the contralateral ischemic extremity. The ankle/brachial indices of all patients significantly improved after the procedure (from a mean of 0.32 to a mean of 0.75) and all grafts are patent to date (mean follow-up 10 months). There were no deaths or limb loss in this group of patients. These favorable results indicate that this minimally invasive approach, which permits a new arterial graft to be inserted through a remote access site, is a valuable method for providing unobstructed arterial inflow after aortoiliofemoral graft failure. This procedure may be particularly valuable when there are contraindications to the use of axillary arteries or the thoracic aorta as alternatives to complex reoperative abdominal aortic surgery.

Aged↗

Clinical application of endovascular grafts in aortoiliac occlusive disease and vascular trauma.

Intravascular stents and stented grafts are becoming important tools for the management of a variety of vascular lesions. This review addresses the technical feasibility and early results of aortoiliac endovascular reconstructions for limb salvage as well as the placement of stented grafts for the treatment of traumatic arterial lesions. Eighteen patients with limb-threatening ischemia secondary to aortoiliac and femoropopliteal occlusive disease who were poor candidates for standard arterial bypass operations and eight patients with traumatic arterial lesions (two arteriovenous fistulas; six pseudoaneurysms) were treated with endovascular stented grafts. These were constructed of 6-mm tubular polytetrafluoroethylene (GORE-TEX) and balloon-expandable stents (Palmaz). Technical success was achieved in 95% of grafts placed to treat long segment occlusive disease of the iliofemoral arteries and in 100% of grafts placed to treat traumatic arterial injuries. There were no deaths and only minor complications in both groups. Although the early results with these grafts are encouraging, long-term follow-up is needed before such devices can be recommended for widespread use.

Aged↗

Prospective study of the value of prebypass saphenous vein angioscopy.

BACKGROUND: The patency of a saphenous vein graft is directly related to the quality of the vein harvested. Thus, appropriate evaluation of the vein before implanting it as a bypass graft may help identify those veins at high risk for early failure. Accordingly, we prospectively investigated whether prebypass angioscopic assessment of the saphenous vein could identify those vein grafts at particularly high risk of early failure. PATIENTS AND METHODS: Thirty-two greater saphenous veins with a grossly normal appearance were evaluated angioscopically before their use as a bypass conduit. After modification of abnormal segments, all of the veins irrigated well and were used as bypass grafts. RESULTS: Twenty-four patients were available for follow-up at 12 months. Seventeen (71%) had been prospectively classified as having angioscopically normal saphenous veins, while 7 were identified as having abnormal veins. The two groups did not differ significantly in demographics, cardiovascular risk factors, or indications for operative intervention. Twelve of the 17 (70%) normal veins were patent at 1 year; however, only 1 (14%) of the angioscopically abnormal vein grafts remained patent for 12 months (chi-square = 4.27; P = 0.039). CONCLUSION: Angioscopic inspection of the saphenous vein, before insertion as a graft, allows for identification of unrecognized venous disease that portends early graft thrombosis. Exclusion of abnormal veins, based on an abnormal angioscopic appearance, may lead to improved results for lower-extremity revascularization procedures; this supports the value of vein-graft angioscopy.

Angioscopy↗