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Objective The objective of this study was to investigate the safety and feasibility of treating infrapopliteal lesions using a novel drug delivery catheter locally delivering liquid paclitaxel. Background Balloon angioplasty is currently the Gold Standard to treat below-the-knee disease; however, restenosis continues to be a great challenge following these percutaneous revascularization procedures. Methods The Occlusion Perfusion Catheter for Optimal Delivery of Paclitaxel for the Prevention of Endovascular Restenosis (COPPER-A) study-Below-the-Knee Cohort was a prospective, nonrandomized, multicenter, feasibility, and safety study that enrolled 35 patients at 11 participating sites. The safety endpoints at 1, 3, and 6 months were freedom from thrombosis, major amputation in the target limb and target limb related death. The efficacy endpoints were primary patency and freedom from clinically driven target lesion revascularization at 6 months. Results All patients tolerated the procedure well with no reports of adverse procedural events. Thirty-five patients were treated with a mean lesion length of 112 ± 81.2 mm with the lesion length range of 20-286 mm. At 6-month follow-up, primary patency was 89.3% and freedom from clinically driven target lesion revascularization was 96.4%. No patients demonstrated thrombosis, major amputation in the target limb and target limb related death at the 1-, 3- and 6-months follow-up intervals. Conclusions The results of this multi-center study demonstrated that infrapopliteal arteries can be safely and effectively treated with liquid paclitaxel using the occlusion perfusion catheter.

Objectives: The purpose of this study was to evaluate the safety and efficacy of excimer laser atherectomy (ELA) with adjunctive percutaneous transluminal angioplasty (PTA) versus PTA alone...

Objectives The purpose of this study is to compare post-dilation strategies of nitinol self-expanding stents implanted in the superficial femoral artery of diabetic patients with peripheral arterial disease. Background Endovascular treatment of superficial femoral artery disease with nitinol self-expanding stents is associated with high rates of in-stent restenosis in patients with diabetes mellitus. Methods We conducted a prospective, multicenter, randomized, controlled clinical trial of diabetic patients to investigate whether post-dilation of superficial femoral artery nitinol self-expanding stents using a cryoplasty balloon reduces restenosis compared to a conventional balloon. Inclusion criteria included diabetes mellitus, symptomatic peripheral arterial disease, and superficial femoral artery lesions requiring implantation of stents >5 mm in diameter and >60 mm in length. Primary endpoint was binary restenosis at 12 months, defined as ≥2.5-fold increase in peak systolic velocity by duplex ultrasonography. Results Seventy-four patients, with 90 stented superficial femoral artery lesions, were randomly assigned to post-dilation using cryoplasty (n = 45 lesions) or conventional balloons (n = 45 lesions). Mean lesion length was 148 ± 98 mm, mean stented length was 190 ± 116 mm, mean stent diameter was 6.1 ± 0.4 mm, and 50% of the lesions were total occlusions. Post-dilation balloon diameters were 5.23 ± 0.51 mm versus 5.51 ± 0.72 mm in the cryoplasty and conventional balloon angioplasty groups, respectively (p = 0.02). At 12 months, binary restenosis was significantly lower in the cryoplasty group (29.3% vs. 55.8%, p = 0.01; odds ratio: 0.36, 95% confidence interval: 0.15 to 0.89). Conclusions Among diabetic patients undergoing implantation of nitinol self-expanding stents in the superficial femoral artery, post-dilation with cryoplasty balloon reduced binary restenosis compared to conventional balloon angioplasty. (Study Comparing Two Methods of Expanding Stents Placed in Legs of Diabetics With Peripheral Vascular Disease [COBRA]; NCT00827853 )

Obstructive sleep apnea (OSA) is associated with an increase in high-sensitivity C-reactive protein (hs-CRP). Studies suggested that the degree of severity of OSA in obese patients with no known coronary artery disease correlates with higher levels of hs-CRP and that continuous positive airway pressure (CPAP) could reduce this inflammation marker. In this study we tested the hypothesis that CPAP therapy could also reduce hs-CRP in cardiac patients with multiple comorbidities and known OSA. Sixty-two consecutive patients were included in this study. All patients were referred for a sleep test because of clinical suspicion of OSA. Clinical variables, body mass index (BMI), hs-CRP, and lipid profile were obtained at the time of their referral and at 126.2 ± 33.7 days followup. Thirty-four patients (group A) underwent CPAP therapy and 28 patients did not (group B). The linear regression of hs-CRP level on the severity of the apnea–hypopnea index (AHI) was significant (p = 0.05), but this significance is lost when ln(hs-CRP) was used (p = 0.263). Through analysis of covariance, ln(hs-CRP) was predicted by BMI (p = 0.000) (R-Sq = 46.2%). In group A, and despite a significant drop in the AHI with CPAP [median difference = −29.7 (−41.8, −22.2)], there were no significant differences in patients’ BMI, lipid profile, or hs-CRP [median difference = −0.15 (−0.83, 0.64)] (p = 0.53) on followup. When both groups A and B were compared, they had matched BMI, lipids, ejection fraction, blood pressure, age, creatinine, awake O2 saturations, alcohol consumption, coronary artery disease, and baseline and followup hs-CRP despite significant differences in baseline AHI (37.65 vs 14.30, respectively, p = 0.000). We conclude that the degree of OSA or CPAP treatment does not independently predict levels of ln(hs-CRP) in cardiac outpatients when other clinical variables, BMI, and lipids are adjusted for. BMI remains the strongest independent predictor of hs-CRP in this patient population.

Endothelial dysfunction is an integral part of atherosclerosis and leads to a chronic inflammatory process within the atheromatous plaque. Measurements of inflammatory markers, particularly high-sensitivity C-reactive protein (hs-CRP), can predict future cardiovascular events in the apparently healthy population and in the cardiovascular patient irrespective of lipid levels. Also, an elevated hs-CRP was a predictor of adverse events in patients undergoing revascularization and in unstable coronary patients. The inflammatory response seems to be independent of the extent of the atherosclerotic burden and might reflect a vascular hyperresponsive state to injury that varies among individuals and could be partly genetically predetermined. Inflammatory markers are currently being incorporated in predictor models of cardiovascular risk and in the stratification of responders to therapy.

PURPOSE To present real-world data to evaluate the safety and effectiveness of bivalirudin, a direct thrombin inhibitor, in an unselected group of patients undergoing percutaneous peripheral interventions (PPI). METHODS Data were extracted from a prospectively collected peripheral vascular registry developed for quality assurance measures at 2 centers. Of 398 consecutive patients (195 men; mean age 69.4+/-11.3 years) who underwent PPI in a 2-year period, 369 (92.7%) received bivalirudin (0.75 mg/kg bolus followed by a 1.75 mg/kg/h infusion) and 29 (7.3%) received unfractionated heparin (UFH). In the bivalirudin sample, critical limb ischemia was present in 28.0% of patients, TASC D lesion in 29.5%, and angiographic thrombus in 7.8% of vessels. Demographic, clinical, procedural, and angiographic variables and in-hospital complications were analyzed. All in-hospital adverse events were independently adjudicated. RESULTS Procedural success (

Background The paclitaxel drug-eluting stent (Taxus, Boston Scientific) is FDA approved for treatment of coronary artery disease in simple, noncomplex coronary lesions. In this registry, we sought to investigate the procedural success and long-term outcomes of patients receiving the Taxus stent in the setting of acute ST-elevation myocardial infarction (STEMI) in a busy single-center interventional program. Methods This is a single-center retrospective analysis of prospectively collected in-hospital data with postdischarge follow-up achieved by phone calls and review of medical records. Data were audited by an independent monitor, and outcomes were adjudicated by an experienced interventional cardiologist. All patients with STEMI over the period of 2 years (2005 and 2006) with native de novo lesions who received the Taxus stent were included. Patients receiving bare metal stents were excluded. The primary outcome was the combined end point of cardiac death, recurrent nonfatal MI, and target lesion revascularization (TLR) on follow-up. Results Of 198 patients included in this study, follow-up data were obtained in 172 (86.9%) patients. The mean age was 63±14.9 years. There were 59.1% males. Patients had the following cardiac risk factors: diabetes 20.7%, hypertension 60.6%, hyperlipidemia 87.8%, and current smoking 48%. In-hospital complications included death 5.1%, acute closure with stent thrombosis 1%, vascular complications 2.9%, and cardiogenic shock 6.6%. The mean follow-up period (days) was 317.3±239.3. The primary end point of cardiac death, nonfatal MI, and TLR was met in 12.4%. Individual end points on follow-up were cardiac death 2.5%, total death 4.9%, TLR 8.1%, target vessel revascularization 19.9%, stroke 1.2%, nonfatal MI 5%, and acute stent thrombosis 5.5% (definite 4.3%, probable 0.6%, possible 0.6%; Academic Research Consortium definition). Conclusion The use of the Taxus stent in acute STEMI is associated with a low postdischarge combined end point of cardiac death, nonfatal MI, and TLR and a definite/probable 4.9% in-stent thrombosis rate, which is within the reported range of data published in "real-world" registry.

To report the results from a single-center prospective registry (DEEP EMBOLI) established to evaluate distal embolization during percutaneous lower extremity interventions using excimer laser ablative therapy.Elective patients with infrainguinal occlusive disease were eligible for this registry if the lesion(s) met one or more of these angiographic criteria: (1) moderate or severe calcification of any length, (2) total occlusions of any length, (3) a filling defect, (4) irregular (ulcerated) lesions at least 30 mm in length, and/or (5) smooth, non-ulcerated lesions at least 50 mm in length. In all, 20 patients (15 women; mean age 70.9+/-10.8 years) with 28 lesions (de novo 13, restenotic 15) were enrolled and underwent treatment with laser atherectomy. SpiderFx filters were utilized before laser treatment in 18 of 20 patients and before final definitive treatment with angioplasty +/- stenting in all 20 patients. The primary angiographic outcome was a residual narrowing of30% or 30% to 50% with20 mmHg gradient across lesion after final treatment. The primary safety endpoint was the embolization rate produced by the laser based on the presence of clinically significant (or=2 mm long) macrodebris in the filter.Adjunctive angioplasty and stenting were performed in 27 (96.4%) and 17 (60.7%) lesions, respectively. All filters were deployed and retrieved successfully, with no complications. The primary angiographic endpoint was met in 100% of patients. Macrodebris was found in 12 (66.7%) of 18 patients after treatment with the laser [4 (22.2%) filters with clinically significant emboli] and in 7 (35%) of 20 patients after adjunctive treatment [4 (20.0%) clinically significant emboli]. One (5.0%) distal embolization occurred after filter removal prior to completion of definitive treatment.Embolization does occur with laser photoablation in the lower extremity, but the rate of clinically significant macrodebris is low ( approximately 20%) and similar to that found after angioplasty and stenting. Embolic filter protection appears to be very effective in capturing macrodebris, and its use is associated with good acute angiographic outcome. Problems with filter retrieval were not encountered.

Severe graft disease occurs in patients at a rate of approximately 15% within the first year of coronary artery bypass grafting (CABG). In this study, the authors examined predictors of the combined end point of death, nonfatal myocardial infarction (MI), and bypass graft disease at 2-year follow-up after CABG. One hundred twenty-one consecutive patients were included in this study after informed consent was obtained. In univariate analysis, there was a significantly (P

To report the results from a single-center prospective registry (PROTECT) established to evaluate the safety and effectiveness of embolic filter protection (EFP) in reducing distal embolization during percutaneous lower extremity interventions.Patients undergoing angioplasty, stenting, or SilverHawk atherectomy and adjunctive balloon angioplasty for infrainguinal occlusive disease were eligible if the lesion(s) met one or more of these angiographic criteria: (1) moderate or severe calcification of any length, (2) total occlusions of any length, (3) a filling defect, (4) irregular (ulcerated) lesions at least 30 mm in length, and/or (5) smooth, non-ulcerated lesions at least 50 mm in length. The primary angiographic outcome was the ability of the filter to prevent angiographically visible distal embolization, slow flow, and loss of distal tibial runoff with or without capturing macrodebris.Forty patients (23 men; mean age 71.4+/-11.5 years) with 56 lesions (42 de novo and 14 restenotic) underwent treatment with angioplasty/stenting (group A, n = 29; 43 lesions) or SilverHawk atherectomy (group B, n = 11; 13 lesions). One filter was used per patient (25 SpiderFX and 15 EmboShield). Macroembolization occurred in 22 (55.0%) patients, 11 (37.9%) in group A and 11 (100%) in group B (p0.001). Clinically significant (or =2 mm in diameter) macrodebris was found in 18 (45.0%) patients: 8 (27.6%) in group A and 10 (90.9%) in group B (p0.001). All filters were retrieved successfully with no complications. One side-branch embolization occurred proximal to the filter. In another case, the filter was overfilled, resulting in no distal flow; it was retrieved, with subsequent tibial embolization when the procedure was continued without protection.Macroembolization is very frequent in patients undergoing lower extremity interventions, particularly with SilverHawk atherectomy. EFP appears to be very effective in capturing macrodebris, and its use is associated with good acute angiographic outcome. The clinical significance of these findings needs to be determined in future studies.

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 2×2 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 P P P =0.08). An interaction was observed between abciximab and embolic protection ( P P 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.

Peripheral arterial disease (PAD) is frequently diagnosed after permanent damage has occurred, resulting in a high rate of morbidity, amputation, and loss of life. Early and ongoing diagnosis and treatment is required for this progressive disease. Lifestyle modifications can prevent or delay disease progression and improve symptoms. Limb-sparing endovascular interventions can restore circulation based on appropriate diagnostic testing to pinpoint vascular targets, and intervention must occur as early as possible to ensure optimal clinical outcomes. An algorithm for the diagnosis and management of PAD was developed to enable a collaborative approach between the family practice and primary care physician or internist and various specialists that may include a diabetologist, endocrinologist, smoking cessation expert, hypertension and lipid specialist, endovascular interventionalist, vascular surgeon, orthopedist, neurologist, nurse practitioner, podiatrist, wound healing expert, and/or others. A multidisciplinary team working together has the greatest chance of providing optimal care for the patient with PAD and ensuring ongoing surveillance of the patient’s overall health, ultimately resulting in better quality of life and increased longevity for patients with PAD., Video abstract

Peripheral vascular disease (PVD) is very prevalent in the United States and is part of a global vascular problem. PVD patients have a heightened inflammatory state and are at high risk of death from acute cardiovascular problems rather than from progression of PVD. Modifiable risk factors for PVD include smoking, hypertension, diabetes, hyperlipidemia, elevated high sensitivity C-reactive protein, obesity, and the metabolic syndrome. Symptomatic treatment of claudication includes smoking cessation, exercise, cilostazol, statins, and revascularization with percutaneous or surgical therapy. Antithrombotic therapy with aspirin or clopidogrel is important to reduce cardiovascular events but does not affect symptoms of claudication. Patients with rest limb ischemia or ulceration should be revascularized to minimize the chance of limb loss. Percutaneous revascularization is not without significant complications, however, and future research needs to focus on inflammation, thrombosis, and restenosis in the PVD patient. Finally, new devices that tackle difficult lesions, drug-eluting stents, and pharmacologic agents that reduce global atherosclerosis are on the horizon and are likely to become critical components in the management of the PVD patient.

The purpose of this prospective, multicenter trial was to evaluate the safety and effectiveness of the TRAP Vascular Filtration System (VFS) to reduce embolic complications during stenting of diseased saphenous vein grafts (SVGs). Patients with SVG lesions were randomly assigned to undergo stenting with or without the TRAP device. The trial was designed to enroll 752 randomized patients. However, the sponsor terminated the study after a total of 467 patients (358 randomized) were enrolled because of poor recruitment once another distal protection device was approved for clinical use. The primary study endpoint, major adverse cardiac events at 30 days, occurred in 17.3% of control patients and 12.7% of patients treated with the TRAP device (P = 0.24). There was a trend toward a lower incidence of myocardial infarction in the TRAP group compared with the control group (16.2% vs 10.5%, P = 0.12). This difference was predominantly due to a lower incidence of moderate-large infarction (CKMB >5×) in the TRAP group. Use of the TRAP VFS during SVG intervention was safe and was associated with a trend toward a lower incidence of adverse events, however, due to low enrollment the study lacked sufficient power to detect a significant benefit with the device.

Objectives The aim of this study was to discern a target range of anticoagulation for enoxaparin during percutaneous coronary intervention (PCI) as measured by the Rapidpoint ENOX (Pharmanetics Inc., Morrisville, North Carolina), a new point-of-care test. Background In the U.S., enoxaparin has been used in only a small proportion of PCI procedures, partly because a rapid enoxaparin-specific assay was unavailable. Methods We analyzed data from 445 enrolled patients receiving subcutaneous or intravenous enoxaparin in a prospective, multicenter study. Serial anticoagulation measurements and clinical outcomes were recorded. Results The in-hospital composite occurrence of death, myocardial infarction, and urgent target vessel revascularization was 5.4%, and Thrombolysis In Myocardial Infarction (TIMI) major bleeding, minor bleeding, and any reported bleeding occurred in 0.2%, 1.3%, and 7.9% of patients, respectively. No significant association between procedural ENOX times and ischemic events was observed (p = 0.222), although the event rate was 4.0% among those with ENOX times between 250 to 450 s versus 7.2% for those outside this range (p = 0.134). Increasing ENOX time at sheath removal was correlated with any bleeding (p = 0.010) with a 1% increase for every ∼30-s rise. Conclusions Ischemic events were infrequent, and the rate appeared lowest in the mid-range of ENOX times. Bleeding events increased with increasing ENOX times. These observations, combined with a suggested procedural anti-Xa level of 0.8 to 1.8 IU/ml, translate into a recommended ENOX time range of 250 to 450 s for PCI and

The purpose of this study was to evaluate the safety and efficacy of excimer laser atherectomy (ELA) with adjunctive percutaneous transluminal angioplasty (PTA) versus PTA alone for treating patients with chronic peripheral artery disease with femoropopliteal bare nitinol in-stent restenosis (ISR).Femoropopliteal stenting has shown superiority to PTA for lifestyle-limiting claudication and critical limb ischemia, although treating post-stenting artery reobstruction, or ISR, remains challenging.The multicenter, prospective, randomized, controlled EXCITE ISR (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis) trial was conducted across 40 U.S. centers. Patients with Rutherford Class 1 to 4 and lesions of target lesion length ≥4 cm, vessel diameter 5 to 7 mm were enrolled and randomly divided into ELA + PTA and PTA groups by a 2:1 ratio. The primary efficacy endpoint was target lesion revascularization (TLR) at 6-month follow up. The primary safety endpoint was major adverse event (death, amputation, or TLR) at 30 days post-procedure.Study enrollment was stopped at 250 patients due to early efficacy demonstrated at a prospectively-specified interim analysis. A total of 169 ELA + PTA subjects (62.7% male; mean age 68.5 ± 9.8 years) and 81 PTA patients (61.7% male; mean age 67.8 ± 10.3 years) were enrolled. Mean lesion length was 19.6 ± 12.0 cm versus 19.3 ± 11.9 cm, and 30.5% versus 36.8% of patients exhibited total occlusion. ELA + PTA subjects demonstrated superior procedural success (93.5% vs. 82.7%; p = 0.01) with significantly fewer procedural complications. ELA + PTA and PTA subject 6-month freedom from TLR was 73.5% versus 51.8% (p0.005), and 30-day major adverse event rates were 5.8% versus 20.5% (p0.001), respectively. ELA + PTA was associated with a 52% reduction in TLR (hazard ratio: 0.48; 95% confidence interval: 0.31 to 0.74).The EXCITE ISR trial is the first large, prospective, randomized study to demonstrate superiority of ELA + PTA versus PTA alone for treating femoropopliteal ISR. (Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis [EXCITE ISR]; NCT01330628).

Thrombus is highly prevalent in patients with recent symptoms (6 months) of claudication or limb ischemia due to an occluded culprit lower extremity vessels. Treatment of these thrombotic occlusions is challenging. In this feasibility study, the excimer laser (Spectranetics, Colorado Springs, CO) has been tested for its safety and ability to ablate thrombus in patients with recent arterial occlusions.Angiographic operator assessment and volumetric core lab quantitation of the thrombus were performed at baseline and after excimer laser but prior to definitive treatment of the vessel to evaluate thrombus resolution. Consecutive patients were prospectively enrolled at a single site. Procedural success was defined as achieving a residual stenosis of30% after final treatment with no intraprocedural complications requiring additional treatment.20 consecutive patients were enrolled in this study (8 males, mean age 69.5±11.1 years). Based on patients symptom onset, 12 patients were subacute (24 h,30 days), and 8 chronic (between 1 to 6 months). 15/20 (75%) had restenotic occlusions. Due to the long, occlusive nature of these lesions, only 8 patients had complete intravascular ultrasound images at each time point which allowed volumetric analysis by the core lab. There was no statistical difference in plaque/thrombus volume between baseline (pretreatment) and excimer laser (P=.68). There was however a significant reduction in residual angiographic stenosis post laser alone (100% vs. 66.75%±23.9%, P=.001). Procedural success was 100%. There were no deaths or amputations. Bail out stenting was performed in 10/20 (50%) patients. Embolic filters were used in 15/20 (75%) of patients. Macrodebris2 mm were seen in 85.7% of filters. There was no in-hospital or 30-day reocclusion of the treated vessel but one patient had a vascular access complication (small AV fistula) conservatively managed. No other serious adverse events were noted.Using the excimer laser appears safe in this small feasibility study of subacute and chronic thrombotic occlusions. Angiographically, there was a significant reduction in percent stenosis with the laser alone. The limited IVUS data did not show a reduction in plaque/thrombus volume but the number of interpretable ultrasounds was small. Further data are needed to address the effectiveness of the laser in treating these thrombotic occlusions and its advantages over balloon angioplasty.

The purpose of this study is to compare post-dilation strategies of nitinol self-expanding stents implanted in the superficial femoral artery of diabetic patients with peripheral arterial disease.Endovascular treatment of superficial femoral artery disease with nitinol self-expanding stents is associated with high rates of in-stent restenosis in patients with diabetes mellitus.We conducted a prospective, multicenter, randomized, controlled clinical trial of diabetic patients to investigate whether post-dilation of superficial femoral artery nitinol self-expanding stents using a cryoplasty balloon reduces restenosis compared to a conventional balloon. Inclusion criteria included diabetes mellitus, symptomatic peripheral arterial disease, and superficial femoral artery lesions requiring implantation of stents5 mm in diameter and60 mm in length. Primary endpoint was binary restenosis at 12 months, defined as ≥2.5-fold increase in peak systolic velocity by duplex ultrasonography.Seventy-four patients, with 90 stented superficial femoral artery lesions, were randomly assigned to post-dilation using cryoplasty (n=45 lesions) or conventional balloons (n=45 lesions). Mean lesion length was 148±98 mm, mean stented length was 190±116 mm, mean stent diameter was 6.1±0.4 mm, and 50% of the lesions were total occlusions. Post-dilation balloon diameters were 5.23±0.51 mm versus 5.51±0.72 mm in the cryoplasty and conventional balloon angioplasty groups, respectively (p=0.02). At 12 months, binary restenosis was significantly lower in the cryoplasty group (29.3% vs. 55.8%, p=0.01; odds ratio: 0.36, 95% confidence interval: 0.15 to 0.89).Among diabetic patients undergoing implantation of nitinol self-expanding stents in the superficial femoral artery, post-dilation with cryoplasty balloon reduced binary restenosis compared to conventional balloon angioplasty. (Study Comparing Two Methods of Expanding Stents Placed in Legs of Diabetics With Peripheral Vascular Disease [COBRA]; NCT00827853).

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 6 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 6 0.24 at baseline to 0.90 6 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. V C 2012 Wiley Periodicals, Inc.

Purpose Target lesion revascularization (TLR) with primary percutaneous transluminal angioplasty (PTA) versus SilverHawk atherectomy and adjunctive PTA of de novo infrainguinal disease has not been well defined. This study was conducted to compare the two approaches. Materials and Methods In this prospective, two-center randomized trial of PTA versus atherectomy of infrainguinal vessels, the primary endpoint of TLR was evaluated at 1 year. Secondary endpoints included the rate of "bailout" stent placement for suboptimal acute angiographic results and the rate of target vessel revascularization (TVR). Results Fifty-eight patients were included in the study. Of these, 29 (36 vessels) were randomized to the atherectomy arm and 29 (48 vessels) to the PTA arm. Final acute angiographic success rates were 100% in the PTA arm and 97.2% in the atherectomy arm ( P value not significant). There was no statistical difference in TLR (16.7% vs 11.1%) or TVR (21.4% vs 11.1%) between the PTA and atherectomy groups, respectively. Bailout stent placement was performed in 18 of 29 patients (62.1%) in the PTA arm and eight of 29 patients (27.6%) in the atherectomy arm ( P = .017). Major adverse events were similar between the PTA and atherectomy arms. Finally, when embolic filter protection was used, distal macroembolization occurred in 11 of 17 patients (64.7%) treated with atherectomy versus none of 10 in the PTA group ( P Conclusions TLR and TVR at 1 year were statistically similar in atherectomy and primary PTA. Atherectomy reduced the need for bailout stent placement compared with primary PTA.

Objective: The multicenter EPIC (FiberNet Embolic Protection System in Carotid Artery Stenting Trial) single-arm trial evaluated the 30-day outcomes of a new design concept for embolic protection during carotid artery stenting (CAS). Background: Embolic protection filters available for use during CAS include fixed and over-the-wire systems that rely on embolic material capture within a “basket” structure. The FiberNet® Embolic Protection System (EPS), which features a very low crossing profile, consists of a three-dimensional fiber-based filter distally mounted on a 0.014 inch guidewire with integrated aspiration during filter retrieval. Methods: The trial enrolled 237 patients from 26 centers. Demographics, clinical and lesion characteristics, as well as adverse events through a 30-day follow-up were recorded. The mean age of the patients was 74 years, 64% were male and 20% had symptomatic carotid artery disease. Results: The combined major adverse event (MAE) rate at 30 days for all death, stroke, and myocardial infarction was 3.0%. There were three major strokes (two ischemic and one hemorrhagic) and two minor strokes (both ischemic) for a 2.1% 30-day stroke rate. The procedural technical success rate was 97.5% and macroscopic evidence of debris was reported in 90.9% of the procedures. Conclusions: The FiberNet EPS, used with commercially available stents, produced low stroke rates following CAS in high surgical risk patients presenting with carotid artery disease. The unique filter design including aspiration during retrieval may have contributed to the low 30-day stroke rate reported during CAS in patients considered at high risk for complications following carotid endarterectomy (CEA). © 2009 Wiley-Liss, Inc.

To evaluate the safety and efficacy of a modified laser catheter designed for the endovascular treatment of peripheral artery disease (PAD) affecting the superficial femoral artery (SFA) and proximal popliteal artery.The CliRpath Excimer Laser System to Enlarge Lumen Openings (CELLO) study was a single-arm, prospective registry conducted at 17 investigational sites in the United States. The primary endpoint was the reduction in index lesion percent diameter stenosis (% DS) measured by Doppler ultrasound following laser ablation prior to any adjunctive therapy. The primary safety endpoint was major adverse events at 6 months. Sixty-five patients (39 men; mean age 68.3+/-10.1 years) with intermittent claudication, stenotic lesions70% by visual assessment, a reference vessel diameteror=4.0 andor=7.0 mm, and a total lesion lengthor=1.0 andor=15.0 cm underwent laser-assisted recanalization with optional balloon angioplasty (BA) or BA + stenting. Sixty-five de novo lesions (5.6+/-4.7 cm) in 13 occluded and 52 stenotic arteries were treated.Laser ablation reduced the % DS from 77%+/-15% at baseline to 34.7%+/-17.8%, which was reduced to 21%+/-14.5% after adjunctive therapy with BA (n = 42, 64.6%) or BA + stenting (n = 15, 23.3%). Eight (12.3%) patients did not receive post laser adjunctive therapy. Patency rates (% DS50%) were 59% and 54% at 6 and 12 months, respectively. Target lesion revascularization was not required in 76.9% of CELLO participants within the 1-year follow-up. There were no major adverse events. The study cohort demonstrated a statistically significant improvement in the walking impairment and functional status assessments during follow-up.The data validate the safety and efficacy of the investigational device, with a high clinical success rate and 12-month data indicating freedom from reintervention in the majority of patients treated.

Distal embolization (DE) commonly occurs during peripheral percutaneous interventions (PPI) of the lower-extremity arterial vessels. In this study we evaluate the predictors of DE in a large cohort of patients undergoing PPI at our center.Patients who experienced clinically significant DE (requiring further mechanical or pharmacologic therapy as per operator judgment) were extracted from a peripheral vascular registry that prospectively tracks demographics, clinical, procedural and outcome variables on patients undergoing PPI at our medical center and compared these to patients in the same registry who did not experience DE. Univariate analysis was utilized to compare patients with and without DE. Logistic regression analysis was performed to determine the independent predictors of DE.Of 577 patients, 14 (2.4%) experienced clinically significant DE. By univariate analysis, patients who experienced DE had longer lesion length (130.0 +/- 123.35 mm vs. 90.05 +/- 104.94 mm; p = 0.049), more severe angiographic pretreatment lesion stenosis (91.71% +/- 14.76% vs. 85.65% +/- 14.26%; p = 0.027), reduced pretreatment TIMI flow (1.21 +/- 1.34 vs. 2.15 +/- 1.1; p = 0.001), a higher rate of prior amputations (21.4% vs. 5.9%; p = 0.052), a higher prevalence of TASC-D lesions (59.3% vs. 29.6%; p = 0.002), more angiographic thrombus (35.7% vs. 6.4%; p = 0.001), and less frequency of chronic onset of symptoms on presentation (64.3% vs. 90.6%; p = 0.009). Logistic regression analysis showed that a prior history of amputation (odds ratio [OR] 3.56, 95% confidence interval [CI] 0.87-14.47; p = 0.08), presence of thrombus (OR 5.02, 95% CI 1.53-16.42; p = 0.008) and TASC-D lesions (OR 4.31, 95% CI 1.24- 15.03; p = 0.022) were independent predictors of DE.Clinically significant DE requiring further mechanical or pharmacologic therapy occurs in approximately 2.4% of patients undergoing PPI. Patients with TASC-D lesions, angiographic thrombus and prior history of amputation are at high risk of DE.

Purpose: To assess the presence of thrombus using intravascular ultrasound (IVUS) andevaluate the feasibility of combined thrombolysis [power-pulse spray (P-PS)] and rheolyticthrombectomy (RT) in patients with recent-onset limb ischemia (,6 months) due to totalocclusion of at least 1 infrainguinal vessel.Methods: Seventeen patients (12 women; mean age 68.3610.7 years) enrolled in aprospective registry underwent IVUS imaging at baseline, after treatment with P-PS usingtissue plasminogen activator and RT (AngioJet), and prior to definitive treatment of thevessel. The primary safety endpoints were major bleeding, distal embolization, vascularaccess complications, and renal failure. Effectiveness outcomes were (1) proceduralsuccess with a residual stenosis ,30%, (2) IVUS-documented resolution of the thrombus,and (3) the combined clinical endpoint of procedure-related death, stroke, unplannedamputation, and unplanned urgent revascularization of the treated limb.Results: At baseline, the majority of patients (16, 94.1%) had a definite thrombus identifiedby IVUS; in the remaining patient (6.3%), thrombus was likely to be present according tothe IVUS scan. By angiography, 2 (11.8%) patients had a definite grade 3 thrombus and 5(29.4%) patients had a grade 1 thrombus (modified TIMI scale) at baseline. IVUS data wereavailable pre and post P-PS/RT in 16 (94.1%) patients. In 10 (62.5%), the thrombus waspartially resolved; in 5 (31.25%), there was no apparent change. The thrombus appeared tohave completely resolved in only 1 (6.3%) patient. Embolization occurred in 3 (17.6%)patients with no adverse clinical sequelae. The combined clinical endpoint was met in 1(5.9%) of 17 patients. After final definitive treatment of the vessel, acute procedural successwas 100%, with no angiographic filling defects seen.Conclusion: Thrombus is present in most if not all patients with a recent history of limbischemia who are found to have an occluded culprit vessel. The application of the P-PS/RTled to partial or complete thrombus resolution in about two thirds of the patients treated.The overall safety outcome was favorable, but large studies are needed to test theeffectiveness of the P-PS/RT technique prior to routine use.J Endovasc Ther 2008;15:570–579

The pattern of use of glycoprotein (GP) IIb/IIIa receptor inhibitors in peripheral percutaneous interventions (PPI) remains unclear. Data on patients who received GP IIb/IIIa inhibitors during PPI were extracted from a prospective registry that tracks demographic, angiographic and in-hospital outcomes of patients at 2 medical centers. Primary success was defined as establishing thrombolysis in myocardial infarction (TIMI) 3 flow and30% residual in vessels treated. Primary safety endpoints included death, unplanned amputation, vascular access complications, major bleeding and thrombocytopenia. Patients were divided into planned versus bailout use of GP IIb/IIIa inhibitors. A total of 46 patients (128 vessels) were included in this study. The procedure was performed emergently, urgently and electively in 13%, 26.1% and 60.9% of patients, respectively. The mean age was 70.9 +/- 11.2 years and 52.2% of patients were males. The patients' Rutherford-Baker Classes III, IV and V-VI were observed in 32.6%, 32.6% and 34.8%, respectively. Patients had the following comorbidities: current smokers 37%, diabetics 35.8%, dyslipidemics 71.7% and hypertensives 78.3%. Angiographic thrombus was suspected in 45.7% of patients prior to and during the procedure. The primary success endpoint was met in 66.4% of vessels and 69.6% of patients. Primary safety endpoints were as follows: death 2.2%, vascular access complication 2.2%, major unplanned amputation 0%, major bleeding 0% and thrombocytopenia 2.2%. Treatment with GP IIb/IIIa inhibitors was planned in 13 (28.3%) patients and bailout in 33 patients (71.7%). Reasons for planned GP IIb/IIIa were the presence of angiographic thrombus in 7 (53.8%) patients, advanced limb ischemia (Rutherford-Baker IV-VI) with total occlusions in 5 (38.5%) patients and acute presentation with total occlusion in 1 (7.7%) patient. Reasons for bailout were slow-flow in 16 (48.5%) patients, thrombus with no slow-flow in 12 (36.4%) patients, poor runoff in 1 (3%) patient and preventative during the procedure in 4 (12%) patients. In patients who received planned GP IIb/IIIa treatment, slow-flow occurred in 1/13 (7.7%) and embolization in 0/13 (0%) patients. We conclude that GP IIb/IIIa inhibitors were used as adjunctive therapy prior to angioplasty in critical limb ischemia patients or thrombotic lesions or as bailout in patients experiencing slow-flow and thrombus during PPI. Planned GP IIb/IIIa inhibitors appear to have favorable outcomes with a low incidence of slow-flow and embolization, however, randomized data are needed before establishing the role of GP IIb/IIIa inhibitor use in high-risk PPI.

The role of different anticoagulants in reducing in-hospital complications in patients undergoing closure of interatrial septal defects (IASD) is unknown. In this study, we review our own experience with IASD closure data to determine if in-hospital complications and ambulation time are influenced by the use of various anticoagulants.Fifty-five consecutive patients with a history of unexplainable stroke or transient ischemic attacks (TIA), with the exception of the presence of an IASD, were included in this study. Multiple variables were collected including age, gender, history of smoking, hypertension, diabetes, hypercholesterolemia, ejection fraction, anticoagulants used pre- and postprocedure, anticoagulants used during the closure procedure, shunt grade across the IASD pre- and postprocedure, defect size, and right-sided filling pressures. Descriptive analysis was performed on all variables including complications frequency and ambulation time, and compared between bivalirudin and indirect thrombin inhibitors.Of 55 consecutive patients included in this study, 22 patients received bivalirudin and 33 patients received unfractionated heparin (UFH) (n = 26) or enoxaparin (n = 7). The bivalirudin patients were older (60.1 vs 50.8 years; p = 0.028), with a higher incidence of interatrial septal aneurysm (75% vs. 40.7%; p = 0.037). In-hospital complications included 1 (5%) patient with a minor bleed (groin hematoma) in the bivalirudin group, and 3 patients with minor bleed (1 GI bleed, 1 groin hematoma, and 1 transient ischemia on electrocardiogram) in the non-bivalirudin group (9.1%). No patient had a major bleed that required a transfusion or prolonged hospital stay. Ambulation time was not significantly different between the two groups (7.7 +/- 5.9 hours for bivalirudin and 6.9 +/- 5.1 hours for other anticoagulants; p = NS).We conclude that bivalirudin is safe during IASD closure, with a statistically nonsignificant trend toward fewer minor complications than UFH and enoxaparin. No major bleeding occurred in either group. This could be due to the fact that IASD closure is performed via venous access that generally carries a low bleeding complication rate and allows safe early ambulation, irrespective of the anticoagulant utilized and despite the use of 10 and 11 Fr sheaths. Given that major differences do not appear to exist in this exploratory study between the anticoagulants studied, patent foramen ovale closure is currently being performed in our laboratory with UFH.

Recent data suggest that percutaneous closure of interatrial septal defect (IASD) is associated with a reduction in the intensity, frequency and duration of migraine headaches. In this study we review our own data to determine if we can reproduce the relationship between IASD closure in patients with a history of a central nervous system event (stroke or a transient ischemic attack [TIA]) and migraine headaches (HA).Fifty-eight consecutive patients with a history of unexplainable stroke or TIA with the exception of the presence of an IASD were included in this retrospective study. Multiple variables were collected including age, gender, history of smoking, hypertension, diabetes, hypercholesterolemia, ejection fraction, anticoagulant use pre- and postprocedure, shunt grade across the IASD pre- and postprocedure, defect size and right-sided filling pressures. All patients with a history of migraine HA answered the Migraine Disability Assessment Test (MIDAS), a standardized migraine questionnaire. Descriptive analysis was performed on all variables and compared among migraine and nonmigraine HA patients. Pre and post closure intensity and frequency of migraine HA were compared.Of 58 patients, 14 (24.14%) had migraine HAs prior to percutaneous closure. There were no significant differences among the migraine and nonmigraine HA groups except that the migraine HA sufferers were younger (p = 0.016). One patient with migraine HA died on follow up from complications of cardiomyopathy. Only 5 (38.5%) of 13 patients reported still having migraine HA post closure of IASD. The frequency (41.6 +/- 36.4 vs. 9.3 +/- 24.8; p = 0.005) and intensity (8.0 +/- 1.9 vs. 2.1 +/- 3.2; p = 0.001) of the migraine HAs were markedly reduced post closure at 759 +/- 545.6 days (range 89 to 1,433 days). There was no relationship between the shunt grade and the frequency or intensity of migraine HA.We conclude that IASD closure in patients with history of migraine HA and stroke or TIA have a marked improvement in the frequency and intensity of their HA. Migraine HA resolved in 61.54% patients post closure. Larger randomized studies are needed to confirm these findings, which could have significant implications for sufferers of migraine HA.

Left main trifurcation coronary artery disease stenting is a challenging and complex percutaneous procedure that has been infrequently reported. We present our own experience with left main trifurcation stenting using the Taxus paclitaxel-eluting stent (Boston Scientific).Twenty consecutive left main trifurcation stenting procedures were performed in 2005 at our institution. The primary endpoint of the study was the combined endpoints of death, acute stent thrombosis and target lesion revascularization (TLR). Conditional logistic regression analysis was performed to determine the predictors of the primary endpoint using a number of variable combinations.The mean patient age was 71.7 +/- 8.9 years. The procedure was urgent in 10%, and the left main artery was unprotected in 95% of cases. Follow up was achieved in 17/20 (85%) patients, either from medical records or by phone calls. The follow-up median duration was 272 days (range 30 to 534 days). The primary endpoint was met in 5/17 (29.4%) patients. One of 19 patients (5.3%) had a sudden cardiac death 1 month after the procedure, 2/20 patients (10%) experienced an acute in-hospital stent thrombosis, and 2/17 (11.8%) patients underwent TLR. Conditional logistic regression analysis could not identify a relationship between the stenting method and the primary endpoint. The 2 patients who experienced in-hospital thrombosis were the only patients who received a clopidogrel load (600 mg) post-procedure after arrival to the floor, and were not on a glycoprotein IIb/IIIa inhibitor. All others received their clopidogrel either during the procedure (n = 7) or were on it chronically (n = 11). One patient with acute stent thrombosis did not have a kissing balloon performed post-stent deployment.Left main trifurcation stenting carries an overall high rate of adverse events and may need to be reserved for patients who are at high risk or who refuse bypass surgery. Overall TLR is low, but stent thrombosis remains a concern. Although we suspect that thrombosis could be related to failure to perform kissing balloon post-stent deployment and/or not receiving a clopidogrel load until after the procedure, the small number of patients in this study prevents us from making definite statistical conclusions about this observation.

The aggressive treatment of hypercholesterolemia improves morbidity and mortality in patients with a history of cardiovascular disease irrespective of gender. Electronically tracked data on 4324 patients enrolled in a community lipid clinic were analyzed for gender differences in lipid values and adherence to national guidelines in lipid management. Women were older, more likely to be diabetic and/or hypertensive, and have a family history of coronary heart disease. Women also had higher initial total cholesterol, low-density lipoprotein, and triglyceride levels and were more likely to be at goal at entry for high-density lipoprotein. Men were more likely to have coronary heart disease and lower high-density lipoprotein and were more likely to be at goal at entry for triglyceride level. There were no gender differences in low-density lipoprotein at goal at entry or rate of current smoking. All lipid parameters appeared better with age, irrespective of gender. More men than women reached goal for their low-density lipoprotein (61.5% vs 51.7%) and triglyceride (36.9% vs 25.1%) levels, whereas more women than men reached goal for their high-density lipoprotein (33.1% vs 22.2%). The authors conclude that there are significant gender differences in lipid values at entry to a community lipid clinic and in achieving National Cholesterol Education Program targets following the initiation of therapy. A possible gender-independent survivorship effect exists for low-density lipoprotein and high-density lipoprotein.

An acute inflammatory response occurs following percutaneous coronary and peripheral vascular interventions (PVI), partly mediated by platelet activation. Glycoprotein (GP) IIb-IIIa inhibitors might partially attenuate this inflammation rise in the coronary patient, but data in patients undergoing PVI are lacking. In the Integrilin Reduces Inflammation in Peripheral Vascular Interventions trial (INFLAME), we hypothesized that eptifibatide reduces the acute inflammatory responses following PVI. This is a single-center, randomized, open-label study of intravenous eptifibatide (180 micro/kg bolus x 2, 10 minutes apart, then 2 micro/kg/min infusion over 18 hours) and low-dose unfractionated heparin (60 Units per kg, target activated clotting time (ACT) 200-250 sec) [LDH+I group; n = 21] versus high-dose unfractionated heparin alone (100 Units per kg, target ACT 300-400 sec) [HDH group; n = 21] in patients undergoing iliac and infrainguinal interventions. The primary endpoints of the study were markers of inflammation (soluble CD-40L [sCD-40L], high-sensitivity C-reactive protein [hs-CRP] and interleukin-6 [IL-6]), thrombin generation (Fragment 1.2 [F1.2]), and fibrinogen measured at baseline and postrandomization. Markers were assayed at baseline, postdilatation at 30 minutes, 2 hours, 18 hours, 48 hours and 7 days. Mean platelet inhibition with eptifibatide was 98% (range 92-100%) using the Accumetrics Rapid Platelet Function Assay at 10 minutes after final bolus. After adjusting for baseline values, the mean +/- SE difference in sCD-40L (loge scale), hs-CRP and F1.2 between the LDH+I group and the HDH was not significant. Fibrinogen had significantly higher mean levels at 7 days for the LDH+I group (541.19 mg/dL versus 472.26 mg/dL; p-value = 0.024). IL-6 was more detectable in the LDH+I group compared to the HDH following intervention. We conclude that LDH+I combination did not reduce acute inflammatory responses as compared to HDH in patients undergoing peripheral vascular interventions.

The left internal mammary (LIMA) is an ideal conduit for bypassing the left anterior descending artery (LAD) during coronary artery bypass surgery (CABG). In this study, we evaluate the frequency of significant disease in the LIMA prior to CABG and describe associated significant lateral costal branches (1.5 mm), subclavian disease and vertebral disease. In 115 consecutive patients referred to CABG, 101 patients met the inclusion criteria. All patients who underwent routine visualization of the LIMA vessels were reviewed and quantitatively analyzed by an independent reader. Disease in the LIMA, left subclavian and vertebral arteries were graded and considered significant if lesions were50%. Lateral costal branches of the LIMA were also noted for their presence and size. Of the 101 patients, 87.1% of the LIMAs prior to surgery were without any disease. One LIMA had a 25-50% narrowing and the remaining LIMAs showed 0-25% disease. Of the LIMAs, 48.5% had lateral costal branches with diameters1.5 mm. The incidence of significant left vertebral disease and proximal subclavian disease was 37.6% and 5%, respectively. Cardiolite stress imaging post-CABG (n = 75) showed that when ischemia persisted in the anterior wall in patients with a LIMA to the LAD, this was not associated with the presence of significant LIMA disease, lateral costal branches, or subclavian disease identified pre-operatively. We conclude that the LIMA rarely shows significant disease on routine visualization prior to CABG. Asymptomatic subclavian artery disease and the presence of lateral costal branches pre-operatively did not correlate with post-CABG ischemia in the LAD territory.

Optical coherent reflectometry, a forward-looking, fiberoptic-guided device was used in 72 patients to direct radiofrequency energy across the central intraluminal portion of 75 chronic total occlusions in peripheral arteries (iliac, femoral, and popliteal) that failed attempts with conventional guidewires. The system was successful in crossing 76% of the chronic total occlusions with no clinical perforations or distal embolizations, and complications consisted of a single dissection greater than or equal to grade C.

Percutaneous stenting has become the procedure of choice for treatment of obstructive atherosclerotic renal artery (RA) disease. Restenosis, however, continues to be in the range of 15-25% of treated vessels. In this study, clinical and angiographic predictors of restenosis were assessed. Of 132 vessels included, fifty-eight were followed for restenosis using duplex Doppler (n=15), conventional angiogram (n=33) or multislice computed tomography (CT) angiogram (n=10). Fifteen vessels (26%) met the criteria for restenosis (lesionor =50% by conventional or CT angiography or60% by Doppler) at a follow-up range of 2-20 months (5%2 months; 68% 3-12 months; 27% 13-20 months). Cox Regression analyses were performed for selected variables. A p-value0.05 was considered statistically significant. History of smoking [odds ratio (OR), 6.6:1; p=0.005] and time to evaluate for restenosis were independent predictors of the occurrence of restenosis. Also, a high restenosis rate (40%) was seen in vesselsor =4 mm in diameter (n=20) in contrast to larger vessels (n=38)4 mm (18.4%). Although statistical significance was not reached (possibly because of the small sample size), clinically this is a significant finding. A significant drop in systolic (-15.6 mmHg) and diastolic (-6.2 mmHg) blood pressures was seen following RA stenting with no significant change in the total number of antihypertensives used (2.4 versus 2.5 for pre- and post-renal stenting, respectively).Restenosis occurred in 26% of successfully stented RAs. History of smoking, time to evaluate for restenosis and small vessels (or =4 mm) were predictors of its occurrence. Clinically, a significant drop in blood pressure was seen with RA stenting without a change in the total number of antihypertensives on follow-up.

The aim of this study was to discern a target range of anticoagulation for enoxaparin during percutaneous coronary intervention (PCI) as measured by the Rapidpoint ENOX (Pharmanetics Inc., Morrisville, North Carolina), a new point-of-care test.In the U.S., enoxaparin has been used in only a small proportion of PCI procedures, partly because a rapid enoxaparin-specific assay was unavailable.We analyzed data from 445 enrolled patients receiving subcutaneous or intravenous enoxaparin in a prospective, multicenter study. Serial anticoagulation measurements and clinical outcomes were recorded.The in-hospital composite occurrence of death, myocardial infarction, and urgent target vessel revascularization was 5.4%, and Thrombolysis In Myocardial Infarction (TIMI) major bleeding, minor bleeding, and any reported bleeding occurred in 0.2%, 1.3%, and 7.9% of patients, respectively. No significant association between procedural ENOX times and ischemic events was observed (p = 0.222), although the event rate was 4.0% among those with ENOX times between 250 to 450 s versus 7.2% for those outside this range (p = 0.134). Increasing ENOX time at sheath removal was correlated with any bleeding (p = 0.010) with a 1% increase for every approximately 30-s rise.Ischemic events were infrequent, and the rate appeared lowest in the mid-range of ENOX times. Bleeding events increased with increasing ENOX times. These observations, combined with a suggested procedural anti-Xa level of 0.8 to 1.8 IU/ml, translate into a recommended ENOX time range of 250 to 450 s for PCI and200 to 250 s for sheath removal.

Unfractionated heparin is a widely utilized anticoagulant during peripheral angioplasty procedures (PTA). In contrast to heparin, bivalirudin is a direct thrombin inhibitor with predictable anticoagulation, does not activate platelets, and inhibits both soluble and bound thrombin. The experience with bivalirudin during PTA remains limited. In this single-center prospective study, 48 consecutive patients (60.4% males, mean age 70.0 12.1) received bivalirudin as the primary anticoagulant during PTA (0.75 mg/kg bolus, 1.75 mg/kg/h during the procedure). Thirty-four (70.8%) had claudication and 6 (12.5%) had ulceration. Thrombus was angiographically seen in 3 (6.3%) patients. In-hospital serious procedural complications were limited to 2 (4.2%) (exact 95% confidence interval: (0.5%,14.3%]) patients with major bleeding; none (0.0%) of the other following endpoints occurred: death, limb loss, emergent need for revascularization of the same vessel, embolic strokes, and vascular complications (exact 95% confidence intervals: [0.0%,6.1%]). This compared favorably to previously reported data using unfractionated heparin and the same serious procedural complications endpoints from our group at the same institution (9.2%). We conclude that the use of bivalirudin during PTA appears feasible and safe. Large prospective registries are needed to confirm these findings.

The hallmark of acute ST-segment elevation myocardial infarction is complete thrombotic occlusion of the infarct-related artery. Reperfusion strategies over the past 25 years have focused on the early restoration of flow in the epicardial artery. More recently, through enhanced understanding of the microvasculature, the open artery hypothesis has moved downstream to also include the complete and early restoration of microvascular flow. Fibrinolytic monotherapy has a ceiling of efficacy, but is universally available. Improvement of early artery patency can be achieved with the addition of a platelet glycoprotein IIb/IIIa receptor antagonist. Mechanical revascularization, via percutaneous coronary intervention, is superior to pharmacologic therapy, but can have limited accessibility. Perhaps the optimal strategy will involve a combination of pharmacologic and mechanical modalities.

Abciximab is a monoclonal, human chimeric antibody with unique pharmacodynamics, pharmacokinetics, and receptor-specificity that distinguishes it from the small-molecule platelet glycoprotein IIb/IIIa receptor inhibitors. Abciximab has consistent, well-defined dosing and robust clinical results. Pooled data across abciximab trials comprising 9290 patients at maximum duration of follow-up demonstrates a 19% reduction in the relative risk of mortality (P =.003). There is a misperception of the cost of abciximab that focuses solely on the acquisition price of the drug. Cost-effectiveness analysis models compare the incremental improvement in clinical outcomes related to the increase in cost. Abciximab is extremely cost-effective in cost per life-year saved and is very attractive economically compared to alternative spending of health care dollars.

AngioSeal (AS) and VasoSeal (VS) are collagen-based arterial closure devices utilized to achieve earlier hemostasis and ambulation in diagnostic and interventional percutaneous procedures. To our knowledge, there has been no randomized studies comparing these two devices as approved for use in the United States. One hundred fifty-seven patients were randomized to receive either the 8 Fr AS (n = 79) or VS (n = 78) closure device. Data on 95 patients who had coronary angiography (49 AS, 46 VS) and 55 patients who underwent angioplasty (28 AS, 27 VS) were completed. Heparin was not administered during the coronary angiogram procedure. The activated clotting time was kept at approximately 300 sec during angioplasty. Patients on coumadin or GP IIb/IIIa platelet inhibitors were not included in this study. The time unit interval to achieve hemostasis in this study was based on the time the AS tension spring was left over the common femoral artery following collagen deployment as per the manufacturer's instructions (20 min). Time to hemostasis, time to ambulation, and major and minor complications were prospectively recorded. Two-tailed t-test and chi-square analysis were performed on continuous and dichotomous variables, respectively. For the angiogram-only subgroup, time (min) to hemostasis (20.51 +/- 4.36 vs. 18.59 +/- 11.77; P = 0.30) and ambulation (145.71 +/- 124 vs. 109.89 +/- 60.37; P = 0.075) were not statistically different for the AS and VS, respectively. Similarly, for the angioplasty subgroup, time (min) to hemostasis (24.23 +/- 12.70 vs. 19.57 +/- 2.27; P = 0.077) and ambulation (607.32 +/- 344.22 vs. 486.48 +/- 200.37; P = 0.12) were not statistically different for both AS and VS, respectively. Furthermore, there were no statistical differences in deployment failure, major, minor, or total complication rates between the two devices. In the absence of GP IIb/IIIa inhibitors, VS and the 8 Fr AS devices have statistically similar time to hemostasis and ambulation as well as device failures and complication rates following coronary angiography and angioplasty.

Coronary perforation is an uncommon but potentially life-threatening complication of percutaneous coronary intervention. The use of both atheroablative technologies for coronary intervention and adjunctive platelet glycoprotein blockade pharmacology may increase the incidence of or risk for life-threatening bleeding complications following the occurrence of coronary artery perforation. The interventional database for 6,214 percutaneous coronary interventions performed between January 1995 and June 1999 was analyzed. Hospital charts and cine angiograms for all patients identified in the database as having had coronary perforation were reviewed. Coronary perforation complicated 0.58% of all procedures and was more commonly observed in patients with a history of congestive heart failure and following use of atheroablative interventional technologies (2.8%). There was no association of abciximab therapy with either the incidence of or classification for coronary perforation. Adverse clinical outcomes (death, emergency surgical exploration) were related to the angiographic classification of perforation and were more frequently observed in patients who experienced a class 3 coronary perforation. These data suggest that specific clinical and procedural demographic factors are associated with the occurrence and severity of angiographic coronary perforation. An angiographic perforation class-specific algorithm for treatment of coronary perforation is proposed.

Purpose: To report the results from a single-center prospective registry (PROTECT)established to evaluate the safety and effectiveness of embolic filter protection (EFP) inreducing distal embolization during percutaneous lower extremity interventions.Methods: Patients undergoing angioplasty, stenting, or SilverHawk atherectomy andadjunctive balloon angioplasty for infrainguinal occlusive disease were eligible if thelesion(s) met one or more of these angiographic criteria: (1) moderate or severecalcification of any length, (2) total occlusions of any length, (3) a filling defect, (4)irregular (ulcerated) lesions at least 30 mm in length, and/or (5) smooth, non-ulceratedlesions at least 50 mm in length. The primary angiographic outcome was the ability of thefilter to prevent angiographically visible distal embolization, slow flow, and loss of distaltibial runoff with or without capturing macrodebris.Results: Forty patients (23 men; mean age 71.4611.5 years) with 56 lesions (42 de novoand 14 restenotic) underwent treatment with angioplasty/stenting (groupA,n529; 43lesions) or SilverHawk atherectomy (group B, n511; 13 lesions). One filter was used perpatient (25 SpiderFX and 15 EmboShield). Macroembolization occurred in 22 (55.0%)patients, 11 (37.9%) in group A and 11 (100%) in group B (p,0.001). Clinically significant($2 mm in diameter) macrodebris was found in 18 (45.0%) patients: 8 (27.6%) in group Aand 10 (90.9%) in group B (p,0.001). All filters were retrieved successfully with nocomplications. One side-branch embolization occurred proximal to the filter. In anothercase, the filter was overfilled, resulting in no distal flow; it was retrieved, with subsequenttibial embolization when the procedure was continued without protection.Conclusion: Macroembolization is very frequent in patients undergoing lower extremityinterventions, particularly with SilverHawk atherectomy. EFP appears to be very effective incapturing macrodebris, and its use is associated with good acute angiographic outcome.The clinical significance of these findings needs to be determined in future studies.J Endovasc Ther 2008;15:270–276Key words: peripheral angioplasty, embolization, embolic filter protection, atherectomy,stent

Femoropopliteal stenting for treatment of peripheral arterial disease has shown superiority to balloon angioplasty (PTA) for the treatment of lifestyle limiting claudication and critical limb ischemia. However, in-stent restenosis (ISR) after femoropopliteal artery stenting remains a challenging

Distal embolization (DE) is a potential complication of percutaneous atherectomy and other endovascular procedures that can lead to poor outcomes for the patient and escalated costs for hospitals. Embolic protection (EP) devices have been shown in several studies to have a low failure rate, and thus