Charles F. Botti

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. Catheter Cardiovasc Interv 2004;61:1–4.

One-year outcomes from an international study of the Ovation Abdominal Stent Graft System for endovascular aneurysm repair.

OBJECTIVE This study evaluated 1-year safety and effectiveness outcomes of the United States regulatory trial for the Ovation Abdominal Stent Graft System (TriVascular Inc, Santa Rosa, Calif) for endovascular repair of abdominal aortic aneurysms (AAAs). METHODS This prospective, multicenter, single-arm trial was conducted at 36 sites in the United States, Germany, and Chile to evaluate the safety and effectiveness of the Ovation stent graft. From November 2009 to May 2011, 161 patients (88% males; mean age, 73 ± 8 years) with AAAs (mean diameter, 54 ± 9 mm) were treated with the Ovation stent graft. The main body is a modular two-docking limb device with a 14F outer diameter delivery system, active suprarenal fixation, and polymer-filled proximal rings that accommodate the aortic neck for seal. Main inclusion criteria included proximal aortic neck length ≥ 7 mm, inner neck diameter between 16 and 30 mm, distal iliac landing zones length ≥ 10 mm, and diameter between 8 and 20 mm. Patients were treated under a common protocol, including clinical and imaging follow-up at discharge, 30 days, 6 months, and annually through 5 years. A Clinical Events Committee adjudicated adverse events, an independent imaging core laboratory analyzed imaging, and a Data Safety and Monitoring Board provided study oversight. Complete 1-year follow-up data were available for this report. RESULTS The Ovation stent graft was implanted successfully in 161 patients (100%), including 69 (42.9%) by percutaneous access. General anesthesia was used in 106 patients (65.8%). Technical success was 100%, and mean procedure time was 110 minutes. Median procedural blood loss was 150 mL, and median hospital stay was 1 day. The 30-day major adverse event rate was 2.5%. At 1 year, AAA-related and all-cause mortality were 0.6% and 2.5%, respectively. Major adverse event and serious adverse event rates through 1 year were 6.2% and 38.5%, respectively. The 1-year treatment success rate was 99.3%. The imaging core laboratory reported no stent graft migration or type I, III, or IV endoleaks. At 1 year, type II endoleaks were identified in 34% of patients, and AAA enlargement was identified in one patient (0.7%). No AAA rupture or conversion to open surgery was reported. AAA-related secondary procedures were performed in 10 patients (6.2%) for 12 findings, including endoleak (six), aortic main body stenosis (three), and iliac limb stenosis or occlusion (three). CONCLUSIONS The 1-year results of the Ovation Abdominal Stent Graft System demonstrate excellent safety and effectiveness in treatment of patients with AAAs, particularly in patients with challenging anatomic characteristics, including short aortic necks and narrow iliac arteries. Longer-term follow-up is needed.

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 non-emergent 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.

Excimer laser with adjunctive balloon angioplasty and heparin-coated self-expanding stent grafts for the treatment of femoropopliteal artery in-stent restenosis: twelve-month results from the SALVAGE study.

The aim of the study is to evaluate the safety and effectiveness of treating femoropopliteal in‐stent restenosis (ISR) with debulking with excimer laser followed by implantation of a VIABAHN endoprosthesis.

Treatment of acute limb ischemia with a percutaneous mechanical thrombectomy-based endovascular approach: 5-year limb salvage and survival results from a single center series.

Objectives: The study evaluated long‐term limb salvage and survival of an endovascular approach that incorporates mechanical thrombectomy (PMT) in the management of arterial thrombosis. Background: Acute limb ischemia is associated with a high risk of amputation and death. Previous reports from the United States (U.S.) of surgical and nonsurgical treatments are limited to primarily 30 days to 1 year. Methods: Single‐center, retrospective review of 57 consecutive patients (30 male, 27 female; mean age 63.8 ± 13.8 years) treated for limb threatening ischemia due to thrombotic arterial occlusions. Data includes baseline assessments, procedural outcomes, in‐hospital complications, 30‐day, and long‐term follow‐up. Results: Ninety‐three percent of patients (n = 53) presented with onset of symptoms (<14 days). Angiography following PMT showed thrombus removal complete/substantial 36 (63.6%), partial 16 (28.0%), and minimal 5 (8.8%), respectively. Catheter‐directed thrombolysis was used after PMT in 18 patients (31.6%). In‐hospital success with limb salvage was attained in 96.5% (n = 55) with mortality of 3.5% (n = 2). Thirty‐day limb salvage and mortality were 94.7% (n = 54) and 5.3% (n = 3), respectively. At mean 5‐year follow‐up (mean = 62 months), three patients have been lost to follow‐up. The results of 54/57 (94.7%) are available. Amputation free survival was 94.7% (n = 36/38) with long‐term mortality rate of 29.6% (n = 16/54). Conclusions: Acute limb ischemia treated with PMT alone or in combination with thrombolysis, followed by definitive therapy, results in favorable long‐term limb salvage. Allowing for appreciable long‐term mortality in vascular patients, survivors demonstrate amputation‐free success from the initial endovascular procedure with low reintervention rate.

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.

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. Cathet Cardiovasc Intervent 2002;56:443–449.