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Biomedical subjects

Gary M Ansel

Publications and source records attributed to Gary M Ansel.

18 recordsLinked to original sources
PubMed2006

Protected carotid stenting in high-risk patients with severe carotid artery stenosis.

OBJECTIVES: The purpose of this study was to determine the safety of carotid artery stenting with a unique distal embolic protection system in high-risk patients with severe carotid stenosis. BACKGROUND: Previous studies suggest that some patients with carotid stenosis and serious comorbid conditions are at high risk for carotid endarterectomy, and may be safely treated by carotid artery stenting. METHODS: A prospective non-randomized multicenter registry of 419 patients with severe carotid stenosis and high-risk features for carotid endarterectomy was conducted between April 2004 and October 2004. Carotid artery stenting was performed with the Protégé Self-Expanding Nitinol Stent and the SPIDER Embolic Protection System (ev3 Inc., Plymouth, Minnesota). Aspirin and clopidogrel were prescribed at least 24 h before and three months after revascularization. The primary outcome was the combined incidence of major adverse cardiac and cerebrovascular events at 30 days after intervention, including death, stroke, and myocardial infarction. A secondary outcome was the technical success, defined as successful deployment of all devices, filter retrieval, and final diameter stenosis <50%. RESULTS: Technical success was achieved in 408 of 419 patients (97.4%). The primary end point was observed in 26 patients (6.2%), including death in 8 (1.9%), nonfatal stroke in 14 (3.3%), and nonfatal myocardial infarction in 4 (1%). Independent predictors of death or stroke at 30 days included duration of filter deployment, symptomatic carotid stenosis, and baseline renal insufficiency. CONCLUSIONS: For some patients with severe carotid stenosis and high-risk features for carotid endarterectomy, carotid artery stenting with distal embolic protection is a reasonable alternative for revascularization.

Aged↗
PubMed2006

Functional and clinical outcomes of nitinol stenting with and without abciximab for complex superficial femoral artery disease: a randomized trial.

OBJECTIVE: To evaluate the effect of glycoprotein IIb/IIIa inhibition during nitinol stenting, of superficial femoral occlusive disease. BACKGROUND: Stent implantation in the superficial femoral artery has been associated with suboptimal results while Glycoprotein IIb/IIIa inhibitors have shown improved procedural results during coronary intervention. We evaluated abciximab infusion during (Smart Stent) implantation in superficial femoral obstructions. METHODS: We conducted a randomized placebo controlled trial. The two primary end points include: (1) 9-month restenosis defined as a decrease in ankle brachial index and in-stent duplex ultrasound restenosis: (2) adverse events defined as death (30 days) or repeat revascularization within 9 months. RESULTS: Twenty-seven patients were randomized to abciximab and 24 patients to control (placebo). The primary end point of cumulative restenosis occurred in 15.4% of patients administered abciximab and in 12% administered placebo (P = 0.873). The primary restenosis endpoint in diabetics and total occlusions were similar at 14.3% and 15.4% respectively. The composite end point of 30-day mortality and 9-month revascularization occurred in 5.8% abciximab and 0% (P = 0.274) placebo with no 30-day deaths. Graded treadmill time and Rutherford class were all significantly improved in both groups, but the abciximab group did not appear to demonstrate any identifiable effect. CONCLUSION: (Smart Stent) nitinol stenting of the superficial femoral artery was associated with favorable functional outcomes at 9 months. Adjunctive abciximab did not appear to demonstrate any identifiable effect.

Abciximab↗
PubMed2005

The use of femoropopliteal stent-grafts for critical limb ischemia.

Peripheral vascular disease of the femoropopliteal segment is one of the most common anatomic locations leading to patient symptoms. Traditional open surgical bypass has started to be supplanted by a surge in lower risk endovascular procedures. Though midterm results of endovascular therapy have been acceptable, longer term results, especially in long diffuse disease, appear to be less durable than their surgical alternatives. Recently the Viabahn, a percutaneously placed PTFE stent-graft, has been approved for use in the femoropopliteal artery. Though the majority of the data for this stent-graft has been derived from patients with complex (>10 cm length) lesions, most of the patients have been claudicants. The population with critical limb ischemia is at particularly high risk for cardiovascular mortality and may benefit from this less invasive approach. However, stent-graft utilization is more complex and many variables must be evaluated before and during the procedure to allow for optimal procedural outcomes.

Angiography↗
PubMed2004

Cutting balloon angioplasty of the popliteal and infrapopliteal vessels for symptomatic limb ischemia.

Options for lower limb percutaneous revascularization are limited especially for complex vessel obstruction. Cutting balloon angioplasty (CBA) has been described in the coronary literature as effective for complex disease. We analyzed our peripheral vascular database and report procedural outcomes along with the clinical success at a mean of 1-year follow-up in 73 patients with symptomatic lower limb ischemia undergoing CBA. CBA was successfully completed in all 73 patients (93 vessels; 100%) with predilation necessary in 4% of vessels. Severe intimal dissection or inadequate hemodynamic result necessitated in adjunctive stenting in 20%. There were no incidents of vessel perforation or surgical target vessel revascularization. One patient (1.5%) died during the periprocedural period due to renal failure. After mean follow-up of 1 year (6-21 months), 89.5% of threatened limbs were salvaged. CBA is a safe and feasible option for the treatment of popliteal and infrapopliteal vessels.

Adult↗
PubMed2004

Carotid stenting with a new system for distal embolic protection and stenting in high-risk patients: the carotid revascularization with ev3 arterial technology evolution (CREATE) feasibility trial.

The purpose of this study was to evaluate the feasibility of carotid artery revascularization using a new system for carotid stenting and distal embolic protection in 30 patients with severe carotid stenosis and high risk for carotid endarterectomy (Carotid Revascularization With ev3 Arterial Technology Evolution, or CREATE). Previous studies suggest that patients with carotid stenosis and serious comorbid cardiopulmonary and anatomic conditions are at high risk for carotid endarterectomy. All patients underwent percutaneous revascularization using the Protégé GPS self-expanding nitinol stent (ev3, Plymouth, MN) and the Spider distal embolic protection system (ev3). In-hospital and 30-day outcomes were analyzed. High-risk features included age > 75 years (63%), left ventricular ejection fraction < 35% (20%), and restenosis after prior carotid endarterectomy (53%). Procedural success was 100%. In-hospital complications included severe vasovagal reactions in six patients (20%) and a popliteal embolus in one patient (3.3%), treated by successful embolectomy. During 30 days of follow-up, two patients (6.6%) experienced minor neurological deficits, including transient expressive aphasia that resolved without therapy in one patient and homonymous hemianopsia due to contralateral posterior circulation stroke in one patient. This study supports the feasibility of percutaneous carotid artery revascularization with the Protégé GPS self-expanding stent and Spider distal embolic protection system, which will be evaluated in a large multicenter pivotal trial (CREATE Pivotal Trial).

Aged↗
PubMed2004

Oblique groin incision for endovascular repair of abdominal aortic aneurysms.

PURPOSE: Groin incision for access to the femoral artery is necessary for stent graft repair of abdominal aortic aneurysm (AAA). However, lymphatic and infectious complications can occur during wound healing after surgery. A vertical incision traditionally is used, but a new oblique incision technique has the potential to reduce complications. We report our results from AAA stent repairs performed via oblique incisions at our center for a 33-month period. METHODS: Data for 134 consecutive patients undergoing elective stent repair of asymptomatic infrarenal AAA performed by 2 cardiovascular surgeons at a single center from July 1, 2000, to March 31, 2003, were gathered for analysis. Wound complication percentages for infections, paresthesias, sepsis, and seroma were calculated. RESULTS: In 134 patients, a total of 278 incisions were made. Reasons for extra incisions included improving catheter entry angle (5 cases), tunneling for vascular tapes (3 cases), and initial approach too low (2 cases). The percentages were, however, calculated on a per-patient basis. Thirty day analysis revealed a 0% infection rate, 4.7% incidence of paresthesias, 2.38% rate of wound seroma, and 0% wound sepsis rate. CONCLUSION: Because of the nonexistent infection rate and low wound complication rate, our data supports the use of oblique groin incisions for stent repair of asymptomatic infrarenal AAA.

Aged↗
PubMed2004

The clinical and fiscal impact of endovascular repair of abdominal aortic aneurysms.

PURPOSE: This study analyzed cost, reimbursement, application, and outcome differences between endovascular (ER) and open repair (OR) of abdominal aortic aneurysms (AAA) in a community hospital. METHOD: A total of 187 consecutive elective AAA repairs by both methods (69 ER, 118 OR) performed at a single center between July 2001 and March 2003 were analyzed. Average values in postoperative clinical and fiscal demographics were calculated for this period. RESULTS: The average length of stay was higher for OR than ER (9.38 days versus 1.94 days, P < .001). Significant reductions in operative time (4 hours versus 2.67 hours) and intensive care unit use (100% versus 4.05%) were seen in the ER population. Total hospital costs were slightly higher for OR than ER (21,989 dollars versus 19,668 dollars) despite a considerable difference in cost of the grafts (>11,000 dollars for ER versus <500 dollars for OR). However, hospital charges were much lower for ER than OR (32,660 dollars versus 48,877 dollars), and there was an average loss of 4986 dollars on ER cases versus a profit of 2064 dollars on OR procedures. Thirty-day mortality was not significantly improved in the ER population (1.45% versus 2.54%, P = .05). CONCLUSIONS: Our data suggest that ER offers improvements in hospital convalescence and operating room times but no improvements in fiscal impact or overall morbidity/ mortality rates when similar preoperative medical risks exist.

Adult↗
PubMed2004

Challenges associated with the integration of endovascular repair of abdominal aortic aneurysms in a community hospital.

PURPOSE: There has been considerable debate regarding the proper place for endovascular repair (ER) of abdominal aortic aneurysms (AAAs) versus traditional open repair (OR). Our study compared preoperative patient demographics and outcomes for elective, asymptomatic AAA repairs performed at our center over a 33-month period. METHODS: For this study, we selected 342 consecutive elective infrarenal AAA repairs performed between July 1, 2000, and March 31, 2003, at Riverside Methodist Hospital. The patients underwent either ER or OR, depending on patient and surgeon collaborative determinations. Ruptured and symptomatic AAAs were excluded from our study. Preoperative demographics, anesthesia, complications, and discharge status for the 2 groups were analyzed, and statistical analysis was done to determine statistically significant differences. RESULTS: The preoperative status of the ER and OR patient groups were essentially similar. There were only 3 significant differences between the 2 groups: alcohol use was higher for the OR group than for the ER group (12.0% versus 5.2%; P = .04), and the incidence of type II diabetes mellitus and peripheral vascular disease were lower for the OR group compared with the ER group (6.7% versus 13.4% [P = .04] and 18.3% versus 30.6% [P = .008], respectively). The OR group used more general anesthesia than the ER group (99% versus 86%; P < .001) and had more complications, including dysrhythmia (8.65% versus 1.59%; P = .005), ileus (13.94% versus 0.79%; P < .0001), infection (8.17% versus 0.0%; P = .0007), respiratory complications (12.50% versus 1.59%; P = .0003), and renal complications (5.29% versus 0.79%; P = .032). The ER group had a higher rate of wound hematoma (4.76% versus 0.48%; P = .007). ER patients also had significantly less blood loss (379 mL versus 1930 mL; P < .001), a better independent discharge status (P < .0001), a shorter length of stay (1.8 days versus 8.2 days; P < .001), and a lower mortality rate (0.75% versus 3.85%; P = .0954). CONCLUSIONS: From our study we cautiously continue to encourage the consideration of the ER of AAAs in our patient population while being mindful of its limitations.

Adult↗
PubMed2003

Percutaneous retrograde tibial access in limb salvage.

PURPOSE: To describe a novel technique for percutaneous retrograde access of the tibial vessels after antegrade access failure in patients with chronic limb-threatening ischemia. METHODS: Six patients who had failed antegrade access to infrapopliteal occlusions had attempted retrograde tibial puncture and wire passage into the proximally patent vessel. Endovascular intervention was carried out utilizing standard techniques. The patients were followed for functional class and wound healing. RESULTS: All six patients were successfully recanalized. Five patients experienced rapid and dramatic healing of wounds that had previously been refractory to conservative therapy. The other patient did not experience healing and ultimately died of progressive intractable congestive heart failure in the setting of a severe ischemic cardiomyopathy. CONCLUSIONS: Retrograde tibial access can be a valuable technique in the armamentarium of a peripheral interventionist treating patients with chronic critical limb ischemia.

Arterial Occlusive Diseases↗
PubMed2003

The role of radiation therapy in the treatment of femoropopliteal occlusive disease.

With the success of brachytherapy in the coronary vessels as a guide, it has also shown promising initial results as an adjunct for the treatment and prevention of restenosis of femoropopliteal occlusive disease. With the rapid evolution of endovascular therapy, defining the role of brachytherapy will become even more important. The purpose of this review is to provide an overview of the role of brachytherapy in the treatment of restenosis following femoropopliteal endovascular intervention.

Angioplasty, Balloon↗
PubMed2002

Intra-aortic balloon pump placement following aorto-iliac angioplasty and stent placement.

Approximately 20% of patients are unable to receive an intra-aortic balloon pump (IABP) due to aorto-iliac atherosclerotic disease. Aorto-iliac stenoses can be managed with angioplasty or stent placement; however, there are limited data about this strategy to facilitate IABP placement. Thirty-seven IABPs were placed in 35 patients. A total of 45 revascularization procedures were performed. With revascularization, the minimal lumen diameter increased from 2.78 +/- 1.46 to 6.75 +/- 2.36 mm (P < 0.0001). Limb ischemia occurred following 2/37 (5%) IABP insertions. Limb ischemia was managed with IABP removal and angioplasty. The mortality rate was 32%. Mortality was more common with chronic renal insufficiency (8/11, 73%; P = 0.0014), dialysis-dependent renal failure (3/3, 100%; P = 0.028), and presentation with acute myocardial infarction (8/15 patients, 53%; P = 0.036). Although no patients required vascular surgery for limb ischemia, one patient required surgery for bleeding. Angioplasty or stenting to facilitate IABP placement in patients with peripheral vascular disease is safe and effective.

Aged↗
PubMed2002

Femoropopliteal occlusive disease: diagnosis, indications for treatment, and results of interventional therapy.

The relative role of percutaneous therapy versus bypass surgery for femoropopliteal occlusive disease (FPD) represents an area of great controversy in the field of vascular medicine. This controversy is complicated by the very dynamic therapeutic options that continue to be introduced, particularly on the endovascular side. The purpose of this review is to provide an overview of the current diagnostic modalities available to characterize the level and degree of vascular insufficiency and summarize the currently available endovascular therapeutic options with their clinical role and outcomes. Finally, future therapeutic advances that will soon be evaluated in clinical trials will be discussed.

Arterial Occlusive Diseases↗
PubMed2002

Clinical results for the training-phase roll-in patients in the Intracoil femoralpopliteal stent trial.

The purpose of this study was to report the results of the roll-in patients for the multicenter IntraCoil trial in the femoropopliteal arteries at 9-month follow-up. Ninety-three roll-in patients (mean age, 67.8 +/- 10.5 years; 62.4% male gender) constituted the learning phase for the 22 clinical sites. Obstructive femoropopliteal artery disease up to 15 cm was treated with stenting. Clinical patency was measured over a 9-month period by clinical and hemodynamic data as well as the Rutherford scale. Diabetes mellitus was present in 35.5%. Twenty-nine percent of lesions treated were occlusions. The mean reference diameter for treated lesions was 4.27 +/- 1.11 mm, while the mean lesion length was 3.83 +/- 3.69 cm. Acute angiographic success by operator evaluation was obtained in 98.9% of patients. Major complications occurred in 3.2%. No patient experienced abrupt or subacute closure. There were two reports of failure to deliver assigned stent. In both incidences, the stent was removed without surgical intervention. There were also three reports of stent misplacement (moving during delivery), one report of stent migration, one report of delivery system failure. At 30-day and 9-month follow-up of successfully treated patients, 100%/77.9% remained free of major adverse clinical events (MACE) and 100%/81.8% target lesion revascularization (TLR), respectively. At 9-month follow-up, ankle-brachial index increased from 0.66 +/- 0.22 to 0.83 +/- 0.20 while mean maximum walking time increased form 4.47 +/- 3.02 to 5.91 +/- 3.97 min. The use of the IntraCoil stent appears to have a short learning curve. Excellent clinical and hemodynamic patency is seen at 9 months. The randomized comparison trial comparing the IntraCoil to angioplasty is pending.

Aged↗
PubMed2002

Rheolytic thrombectomy in the management of limb ischemia: 30-day results from a multicenter registry.

PURPOSE: To evaluate the use of rheolytic thrombectomy (RT) with the AngioJet catheter for treatment of lower extremity ischemia due to arterial/graft thrombotic occlusion. METHODS: A retrospective multicenter review was performed of 99 consecutive patients (52 men; mean age 67 +/- 13 years, range 30-90) who underwent RT for thrombotic occlusions in native arteries (n=80) or bypass grafts (n=19). Pre- and postprocedural limb ischemia and in-hospital events were evaluated. Amputation and mortality rates at 30 days were determined. RESULTS: The majority of patients (78.8%) presented within 14 days of symptom onset. RT resulted in substantial to complete thrombus removal in 70 (70.7%) patients and partial in 22 (22.2%); there was no angiographic change in 7 (7.1%). Adjunctive post RT thrombolysis was used in 37 patients. Underlying stenoses found in 81 limbs were treated with one or more of the following procedures: balloon angioplasty (n=62), stenting (n=35), or nonemergent surgical revision (n=5). In-hospital complications included 2 major amputations, 5 cases of minor tissue loss, 7 rethromboses, and 3 cases of transient renal insufficiency. Four (4.0% patients died in-hospital; the 95 surviving patients all had viable limbs at discharge. Mortality and amputation rates at 30 days were 7.1% and 4.0%, respectively. CONCLUSIONS: Percutaneous treatment of thrombotic occlusions with RT, followed by definitive treatment of the underlying stenosis, is a promising therapeutic option for patients with limb-threatening ischemia.

Adult↗
PubMed2002

Complex endovascular treatment for critical limb ischemia in poor surgical candidates: a pilot study.

PURPOSE: To evaluate the effectiveness of complex endovascular treatment for limb salvage in patients with critical limb ischemia. METHODS: In a prospective study, 23 patients (13 men; mean age 70 +/- 11 years, range 44-87) with ischemic ulceration or gangrene of 25 lower limbs were enrolled at 4 sites to evaluate treatment with excimer laser recanalization followed by balloon angioplasty with optional stenting in the superficial femoral, popliteal, and/or tibial arteries. RESULTS: Multiple lesions (mean 3.1, range 1-8) were treated in most cases. Reduction of stenosis/occlusion to <50% was achieved in 22 (88%) limbs. Individual cases of vessel perforation, inability to cross the lesion, and excessive residual stenosis accounted for the 3 failures. Over a 6-month period, 4 patients died of cardiac comorbidity and 1 was lost to follow-up. Adverse events included 4 minor and 2 below-knee amputations, 4 secondary angioplasties, and 4 femorodistal bypasses. The mean wound area reduction was 70% at 3 months, increasing to 89% at 6 months. According to life table analysis, the limb salvage rate was 90% with bypass and 69% without in the successfully treated patients (corresponding intention-to-treat rates were 79% and 61%). CONCLUSIONS: Complex endovascular treatment combining laser debulking and angioplasty/stenting offers an alternative for patients with critical limb ischemia who lack good surgical options.

Adult↗
PubMed2002

Use of glycoprotein IIb/IIIa platelet inhibitors in peripheral vascular interventions.

With the expanding use of endovascular techniques for the treatment of peripheral vascular disease, consideration of glycoprotein IIb/IIIa receptor inhibitors to enhance the safety and efficacy of these procedures has increased. The scientific literature shows the benefits with the use of these agents in coronary vasculature interventions. However, data evaluating treatment with glycoprotein IIb/IIIa receptor inhibitors during peripheral vascular procedures is limited, with the vast majority of the trials investigating abciximab. With the varied vascular beds and end organs that may be affected by peripheral vascular intervention, the safety and efficacy may need to be studies for each area. The current literature ranging from carotid stenting to thrombolysis and mechanical thrombectomy for acute limb ischemia is reviewed, and recommendations are discussed on the use of these agents. The forthcoming results of controlled clinical trials should further clarify the clinical applications of these agents in peripheral vascular intervention.

Humans↗