Limb salvage following laser-assisted angioplasty for critical limb ischemia: results of the LACI multicenter trial.

PURPOSE: To evaluate the effectiveness of laser-assisted angioplasty for patients with critical limb ischemia (CLI) who were poor candidates for surgical revascularization. METHODS: A prospective registry at 14 sites in the US and Germany enrolled 145 patients with 155 critically ischemic limbs; the patients were poor candidates for bypass surgery owing to inadequate target vessel or saphenous vein, prohibitive cardiac disease, or significant comorbidities (ASA class 4). Additional comorbid risk factors included diabetes in 66%, hypertension in 83%, previous stroke in 21%, and myocardial infarction in 23%. Endovascular treatment included guidewire traversal and excimer laser angioplasty followed by balloon angioplasty with optional stenting. RESULTS: Occlusions were present in 92% of limbs. A mean of 2.7+/-1.4 lesions were treated per limb; the total median treatment length was 11 cm (mean 16.2, range 0.2-123). Stents were implanted in 45% of limbs. Procedural success, defined as <50% residual stenosis in all treated lesions, was seen in 86% of limbs. At 6-month follow-up, limb salvage was achieved in 110 (92%) of 119 surviving patients or 118 (93%) 127 limbs. CONCLUSION: Excimer laser-assisted angioplasty for CLI offers high technical success and limb salvage rates in patients unfit for traditional surgical revascularization.

A prospective study of ultrasound scan-guided thrombin injection of femoral pseudoaneurysm: a trend toward minimal medication.

BACKGROUND: Catheterizations and endovascular procedures in which the femoral artery is cannulated are sometimes complicated by iatrogenic pseudoaneuryms. Surgical repair of pseudoaneurysms was the treatment of choice until 1991 when compression was used in those that were small. A less uncomfortable technique involving the ultrasound scan-guided injection of thrombin (UGTI) has been used more recently. The purpose of this study was to prospectively evaluate the effectiveness of ultrasound scan-guided thrombin injection (UGTI) as a treatment of iatrogenic femoral pseudoaneurysms. METHODS: From December 1998 to December 2000, 3734 femoral artery catheterizations were performed, and from those, 32 consecutive patients with 33 femoral pseudoaneurysms (0.88%) of less than 8 cm were prospectively enrolled for UGTI. With sterile technique, a 21-gauge or 22-gauge spinal needle was used to access the pseudoaneurysm and thrombin (100 to 6000 international units [IU]) was slowly injected until thrombosis occurred. RESULTS: The initial success rate was 100%. Thirty-one cases (93.9%) remained successfully thrombosed with a single injection at day 30. Recurrence of two pseudoaneurysms (6.1%) was seen at day 1 and day 8. One patient had groin cellulitis develop, and the other had a bleed into the thigh after discharge; both were treated with open surgical repair. Fifteen patients underwent UGTI on an outpatient basis with 100% successful ablation. More than half of the patients were on an inpatient basis (53.1%). Hospital stay was 1 to 9 days, with 88.2% of the patients released on day 1 or 2. However, two patients had a prolonged stay: one from open repair (day 9) and the other from a gastrointestinal bleed (day 8). Pseudoaneurysms ranged from 1.7 to 7.5 cm and lasted 1 to 17 days before UGTI. Twenty-one of the patients (65.7%) continued undergoing anticoagulant therapy at the time of injection. Ten of the last 11 cases needed less than 800 IU, and nearly half of the pseudoaneurysms (49%) successfully thrombosed with less than 600 IU. No procedural complications or mortality were noted. No statistical significance was found between occurrence of the pseudoaneurysm and sheath size (with chi(2) test, P value =.05) or between the size of the pseudoaneurysm and successful thrombosis (with chi(2) test: degrees of freedom, 6 - 1 = 5; P value =.227426). A mean follow-up period of 11.8 months was documented (range, 71 to 24 months). Seven patients were lost to follow-up at less than 30 days. CONCLUSION: Percutaneous thrombin injection of iatrogenic pseudoaneurysms is an effective treatment. Not only is it minimally painful, but it can be done as an outpatient procedure and anticoagulation therapy does not hinder the success. Minimal thrombin seems necessary to successfully treat pseudoaneurysms that may further limit procedure-related complications.

Endoluminal stent grafting of the thoracic aorta: initial experience with the Gore Excluder.

PURPOSE: The purpose of this study was to describe our experience with endoluminal graft repair of a variety of thoracic aorta pathologies with a commercially developed device currently under investigation. Our patient population included patients eligible for open surgical repair and those with prohibitive surgical risk. METHODS: From February 2000 to February 2001, endovascular stent-graft repair of the thoracic aorta was performed in 46 patients (mean age, 70 years; 29 male and 17 female patients) with the Gore Excluder. Twenty-three patients (50%) had atherosclerotic aneurysms, 14 patients (30%) had dissections, three patients (7%) had aortobronchial fistulas, three patients (7%) had pseudoaneurysms, two patients (4%) had traumatic ruptures, and one patient (2%) had a ruptured aortic ulcer. Patient characteristics, procedural variables, outcome, and complications were recorded. All patients were followed with chest computed tomographic scans at 1, 3, 6, and 12 months. Follow-up period ranged from 1 month to 15 months, with a mean of 8.5 months. RESULTS: All the procedures were technically successful. There were no conversions. Average duration of the procedure was 120 minutes. Average length of stay was 6 days, but most patients (64%) left the hospital within 4 days after endoluminal grafting. The overall morbidity rate was 23%. Two patients (4%) had endoleaks that necessitated a second procedure for successful repair. Two patients (4%) died in the immediate postoperative period. There were no cases of paraplegia. At follow-up examination, one patient had an endoleak found the day after the procedure and another patient had an endoleak 6 months after the procedure. Both cases were treated successfully with additional stent-grafts. There were no cases of migration. One patient died of a myocardial infarction 6 months after graft placement. In patients treated for aneurysm (n = 23), the aneurysm diameter ranged from 5.0 to 9.5 cm (mean, 6.8 cm). Residual sac measurements were obtained at 1, 6, and 12 months, with mean sac reductions of 0.59 cm, 0.77 cm, and 0.85 cm, respectively. In three cases, the sac remained unchanged, without evidence of endoleak. CONCLUSION: Thoracic endoluminal grafting with the Gore Excluder is a safe and feasible alternative to open graft repair and can be performed successfully with good results. Early data suggest an endoluminal approach to these disease entities may be favorable over classical resection and graft replacement.

Endoluminal stent graft repair of aortobronchial fistulas.

OBJECTIVE: To describe our experience with endoluminal stent graft repair of aortobronchial fistulas. METHODS: We reviewed the records of patients treated with endoluminal stent grafting of aortobronchial fistulas at a private teaching hospital. All patients underwent the following diagnostic studies: computed tomography, angiography, bronchoscopy, and transesophageal echocardiography. With standard endovascular techniques, two different devices were implanted. RESULTS: Between March 1997 and October 2000, we treated four patients with postsurgical fistulas. The patients were diagnosed with hemoptysis between 3 and 23 years after aortic replacement grafting for thoracic aneurysms. Diagnostic studies varied in their ability to find the fistula. Transesophageal echocardiography most reliably demonstrated the fistula in the patients. All were successfully treated by exclusion with endoluminal stent grafting. The patients had no complications and no further episodes of hemoptysis. CONCLUSION: Endoluminal stent grafting of aortobronchial fistulas is feasible and may become the preferred method of management in patients at high risk.