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.

OBJECTIVES: 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. BACKGROUND: The optimal treatment strategy for femoropopliteal ISR is unclear. METHODS: The SALVAGE study is a multicenter prospective registry involving nine US centers. Patients with femoropopliteal ISR with moderate to severe intermittent claudication or critical limb ischemia (Rutherford categories 2-5) and an ankle-brachial index (ABI) =0.8 were treated with excimer laser and the VIABAHN endoprosthesis. The primary efficacy endpoint is primary patency at 12 months as measured by duplex ultrasonography. The primary safety endpoint is the major adverse event (MAE) rate at 30 days. RESULTS: Twenty-seven patients were enrolled. The mean lesion length was 20.7 ± 10.3 cm. The majority of lesions were TASC (TASC I) C and D (81.4%). All lesions were pretreated with excimer laser and percutaneous transluminal angioplasty (PTA) prior to VIABAHN implantation. Technical success was achieved in 100% of cases. There were no MAE at 30 days. Primary patency at 12 months was 48%. The ankle brachial index increased from 0.58 ± 0.24 at baseline to 0.90 ± 0.17 at 12 months. There was improvement in all quality-of-life parameters. The 12-month TLR rate was 17.4%. CONCLUSIONS: The strategy of excimer laser atherectomy and PTA followed by implantation of a self-expanding stent graft for the treatment of femoropopliteal ISR is safe and associated with high procedural success. Primary patency rate at 12-months was suboptimal; however, the TLR rate was low.

Embolic protection and platelet inhibition during renal artery stenting.

BACKGROUND: Preservation of renal function is an important objective of renal artery stent procedures. Although atheroembolization can cause renal dysfunction during renal stent procedures, whether adjunctive use of embolic protection devices or glycoprotein IIb/IIIa inhibitors improves renal function is unknown. METHODS AND RESULTS: One hundred patients undergoing renal artery stenting at 7 centers were randomly assigned to an open-label embolic protection device, Angioguard, or double-blind use of a platelet glycoprotein IIb/IIIa inhibitor, abciximab, in a 2x2 factorial design. The main effects of treatments and their interaction were assessed on percentage change in Modification in Diet in Renal Disease-derived glomerular filtration rate from baseline to 1 month using centrally analyzed creatinine. Filter devices were analyzed for the presence of platelet-rich thrombus. With stenting alone, stenting and embolic protection, and stenting with abciximab alone, glomerular filtration rate declined (P<0.05), but with combination therapy, it did not decline and was superior to the other allocations in the 2x2 design (P<0.01). The main effects of treatment demonstrated no overall improvement in glomerular filtration rate; although abciximab was superior to placebo (0+/-27% versus -10+/-20%; P<0.05), embolic protection was not (-1+/-28% versus -10+/-20%; P=0.08). An interaction was observed between abciximab and embolic protection (P<0.05), favoring combination treatment. Abciximab reduced the occurrence of platelet-rich emboli in the filters from 42% to 7% (P<0.01). CONCLUSIONS: Renal artery stenting alone, stenting with embolic protection, and stenting with abciximab were associated with a decline in glomerular filtration rate. An unanticipated interaction between Angioguard and abciximab was seen, with combination therapy better than no treatment or either treatment alone.

Perforation complicating carotid artery stenting: the use of a covered stent.

Carotid artery angioplasty and stenting has emerged as an effective strategy for the treatment of significant carotid artery stenosis. Perforation during carotid artery stenting is a very rare potential complication of the procedure. We describe a case of carotid artery perforation that occurred during postdilation of the carotid artery stent. In our case this potentially serious complication was successfully treated with a covered stent-graft.

Renal artery stenting using gadodiamide arteriography in patients with baseline renal insufficiency.

PURPOSE: To investigate whether a contrast agent containing gadodiamide can reduce the incidence of contrast-induced nephropathy associated with renal artery stenting in patients with preexisting renal insufficiency. METHODS: Between 1999 and 2002, gadodiamide-based arteriography was used in 20 patients (12 men; mean age 69 years) with significant baseline renal insufficiency (creatinine > or =1.7 mg/dL) undergoing renal artery stenting for > or =70% stenoses in 25 renal arteries. Baseline creatinine levels were compared to postprocedure and midterm follow-up levels. RESULTS: Procedural success was 100%. An average of 74 mL of gadodiamide contrast was used per case. Four patients received an additional 30 mL (mean) of iodinated contrast due to poor image quality with gadodiamide alone. There was no significant change in mean creatinine levels at discharge (2.9 mg/dL) compared to baseline (3.0 mg/dL, p=0.72). At midterm follow-up, mean creatinine levels (2.4 mg/dL) were significantly lower compared to baseline (p=0.004). CONCLUSIONS: Gadodiamide-based arteriography can be effectively used during RAS in patients with baseline renal insufficiency. This technique may enhance the renal-protective effect of renal artery stenting in this high-risk population with renal artery stenosis.

Randomized comparison of rapid ambulation using radial, 4 French femoral access, or femoral access with AngioSeal closure.

Radial access and closure devices are associated with improved quality of life (QOL) after cardiac catheterization. Whether this is related to the access site or time to ambulation is unknown. Seventy-five patients undergoing cardiac catheterization were randomized to femoral 6 Fr with AngioSeal closure (F+C), femoral 4 Fr without closure, and radial (R) access. All patients were ambulated at 1 hr. QOL was measured utilizing visual analogue scales and Short Form-36 at baseline, 1 day, and 1 week. Time to ambulation and discharge were equivalent, as was postprocedure QOL. However, angiographic quality was lower in the 4 Fr group (P < 0.0001) and catheterization costs were higher in the F+C group (P < 0.0001). Ambulation 1 hr after catheterization can be accomplished utilizing radial, femoral 6 Fr with closure device, or femoral 4 Fr access with equivalent outcomes and QOL. However, this is achieved at a higher cost with a closure device, or lesser angiographic quality with 4 Fr catheters.

Compliance with antihypertensive therapy after renal artery stenting.

Hypertension is an important clinical endpoint after renal artery revascularization for renal artery stenosis (RAS). Medication compliance is a critical determinant of blood pressure control. Although factors influencing compliance are known in essential hypertension, they have not been evaluated in studies investigating renal artery revascularization. The aim of this study was to assess the determinants of compliance to antihypertensive therapy in patients with RAS following renal artery stent placement (RASP). A cross-sectional study evaluating blood pressure, antihypertensive medications, quality of life, compliance, and determinants of compliance to antihypertensive therapy was undertaken in 112 patients undergoing RASP. Additionally, cardiovascular risk factors, antihypertensive medications, and cardiovascular history were reported. Self-reported compliance was 79% +/- 24% (scale of 0% [none] to 100% [complete] compliance) in patients after RASP. Determinants of compliance by multivariate analysis included physical symptoms, which correlated negatively to compliance and included loss of appetite (r2 = 0.26, P < 0.0001), dizziness (r2 = 0.06, P < 0.01), and cough (r2 = 0.03, P < 0.05). Systolic blood pressure correlated positively with compliance (r2 = 0.03, P < 0.05). The number or class of antihypertensive medications did not influence compliance. Patients' physical symptoms and level of systolic blood pressure, rather than the number or class of medications, influence compliance in patients with continued hypertension after RASP. Attention to physical symptoms may help to improve blood pressure control in this population.