Spontaneous Closure of a Coronary Artery Bypass Graft Pseudoaneurysm Embedded in a Mediastinal Hematoma.

Coronary artery bypass graft (CABG) pseudoaneurysms are a rare but often unrecognized clinical entity. They are prone to rupture and hemodynamic compromise and should therefore be on the differential in the appropriate patient. We present a case of a gentleman with a recent CABG surgery who presented with acute onset dyspnea and a large pleural effusion. Imaging revealed a saphenous vein graft pseudoaneurysm embedded in a mediastinal hematoma. Four weeks later, prior to planned stenting, the pseudoaneurysm had spontaneously closed. This case highlights an unusual acute presentation of a CABG pseudoaneurysm and a multidisciplinary approach to its management.

A Review of the Current Role of Blood Clotting Analyzers in Clinical Practice.

BACKGROUND: Viscoelastic tests (VETs) such as thromboelastography, rotational thromboelastography, and the Sonoclot Analyzer assess the entire process of clot formation through dissolution in real-time, and may provide additional therapeutic value to conventional laboratory coagulation tests. With the ability to obtain rapid results and identify specific coagulopathies, VETs has been examined in a variety of clinical scenarios, including cardiac surgery, trauma, obstetric emergencies, and liver transplant. CONCLUSION: This review provides a summary of clinical trials utilizing VETs in the aforementioned clinical scenarios, and suggests that VETs have demonstrated a capability to identify coagulopathies, utility in guiding algorithms to reduce the amount of transfusions, and a limited ability to predict bleeding events or mortality.

Safety and Effectiveness of the Nav-6 Filter in Preventing Distal Embolization During Jetstream Atherectomy of Infrainguinal Peripheral Artery Lesions.

BACKGROUND: The risk of distal embolization (DE) during infrainguinal peripheral artery interventions (PAI) is often mitigated by the use of embolic protection devices. There are limited data on the use of filters with the Jetstream (JS) atherectomy device, a rotational cutter with aspiration capacity. The Nav-6 filter is uniquely suited for use with the JS due to its wire compatibility and detachment from the filter; however, data on the off-label use of this combination have not been reported. METHODS: Consecutive patients between October 2008 and April 2015 undergoing endovascular infrainguinal PAI with JS were analyzed as part of the Excellence in Peripheral Artery Disease (XL-PAD) registry (NCT01904851). Patients were divided into two subgroups with Nav-6 filter use vs no filter use. Descriptive and univariate analyses were performed. RESULTS: Among 141 patients (mean age, 67.8 ± 10.8 years; 169 lesions) included in this study, the Nav-6 filter was used in 82 (59%). Use of a filter was more frequent in longer lesions (146 ± 106 mm vs 91 ± 72 mm; P=.01), in more severe stenoses (95% vs 87%; P=.04), and in chronic total occlusions (33% vs 8.3%; P=.01). Patients receiving filters had longer procedure duration (102 ± 51 min vs 66 ± 41 min; P=.01) and longer fluoroscopy times (31 ± 16 min vs 21 ± 10 min; P<.001). Use of the Nav-6 filter with the JS during PAI was associated with numerically lower rates of DE (1.8% vs 8%; P=.10) and similar rates of death and amputation. At 12 months, the target-lesion revascularization rate was higher in the filter group (22% vs 2.7%; P=.02), likely secondary to use of the filter in more complex lesions. CONCLUSION: Nav-6 filter during JS atherectomy was predominantly used during complex infrainguinal PAI and was associated with less occurrence of DE.

Femoropopliteal Artery Stent Thrombosis: Report From the Excellence in Peripheral Artery Disease Registry.

BACKGROUND: There are limited data on femoropopliteal artery stent thrombosis (ST), which is a serious adverse outcome of peripheral artery interventions. METHODS AND RESULTS: Index procedures resulting in femoropopliteal ST were compared with stent procedures without subsequent ST in the Excellence in Peripheral Artery Disease registry. The study data had a total of 724 cases of stent procedures and 604 unique patients. Femoropopliteal ST occurred in 26 of 604 patients (4.3%) over a median follow-up of 6 months post procedure. ST was more likely to occur in men (96.3% versus 82.2%; P=0.026) and to have an initial intervention for chronic total occlusions (88.5% versus 64.0%; P=0.01). There was no significant difference in ST between drug-coated and bare-metal stents (4.4% versus 3.4%; P=0.55), but the rate of ST was significantly higher with self-expanding covered stent grafts compared with bare-metal stents (10.6% versus 3.4%; P=0.02). ST was significantly associated with an increased risk of 12-month major adverse limb events (hazard ratio, 4.99; 95% confidence interval, 2.31-10.77; P<0.001) compared with no ST. On multivariate analysis, treatment of chronic total occlusion lesions (odds ratio, 3.46; 95% confidence interval, 0.98-12.20; P=0.05) and in-stent restenosis lesions (odds ratio, 5.30; 95% confidence interval, 1.83-15.32; P=0.002) were independently associated with an increased risk of ST. CONCLUSIONS: In a multicenter peripheral interventional registry, femoropopliteal ST occurred in 4.3% of patients who underwent stent procedures, and it was associated with treatment of chronic total occlusions and in-stent restenosis lesions, and had higher 12-month major adverse limb events. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01904851.

Determinants of operator and patient radiation exposure during cardiac catheterization: Insights from the RadiCure (RADIation reduction during cardiac catheterization using real-timE monitoring) trial.

BACKGROUND: In the RadiCure study 505 catheterization procedures were 1:1 randomized to use or no use of real-time radiation monitoring. Use of the Bleeper Sv monitor resulted in a significant reduction in operator radiation exposure. METHODS: We examined the association between several baseline and procedural parameters with operator and patient radiation exposure using univariable and multivariable analysis in the 505 patients that were enrolled in RadiCure. All baseline demographic and procedure characteristics recorded were included in the univariable analysis. RESULTS: Median fluoroscopy time was 6.2 (2.5-12.5) minutes, median patient air kerma dose was 0.908 (0.602-1.636) Gray and median first operator exposure was 10 (5-22) µSv. For analysis purposes, the 505 procedures were dichotomized based on the median operator exposure (10 µSv) and median patient radiation dose (0.908 Gray). On multivariable analysis, factors associated with high (above median or >10 µSv) first operator radiation exposure included radial access (odds ratio [OR] 5.44, 95% Confidence Interval [CI] 2.88-10.76), chronic total occlusion (CTO) intervention (OR 12.78, 95% CI 4.42-43.60), real-time radiation monitoring (OR 0.42, 95% CI 0.26-0.66), and use of a radioabsorbent drape (OR 0.53, 95% CI 0.28-0.96). High patient radiation dose (above median or >0.908 Gray) was associated with body mass index>30 kg/m2 (OR 3.22, 95% CI 1.99-5.29), prior MI (OR 2.26, 95% CI 1.29-4.04), prior cerebrovascular disease (OR 0.34, 95% CI 0.15-0.75), hypertension (OR 2.40, 95% CI 1.05-5.82), prior coronary artery bypass graft surgery (OR 2.46, 95% CI 1.40-4.39) and CTO intervention (OR 12.93, 95% CI 3.28-87.31), but was not associated with real-time radiation monitoring and use of a radioabsorbent drape. CONCLUSIONS: Several clinical and procedural factors are associated with higher patient and operator radiation exposure. Real-time radiation monitoring and use of disposable radiation shields were associated with lower operator, but not patient, radiation dose. © 2015 Wiley Periodicals, Inc.

The role of antiplatelet therapy in patients with peripheral artery disease and lower extremity peripheral artery revascularization.

PURPOSE OF REVIEW: Although antiplatelet agents are frequently prescribed to patients with lower extremity peripheral artery disease (PAD), there is an overall lack of consensus among published evidence and guidelines with respect to this practice. RECENT FINDINGS: Antiplatelet agents are prescribed to patients with PAD to reduce both cardiovascular and limb-based events during the follow-up period. A large evidence base supports the use of antiplatelet monotherapy with aspirin or clopidogrel in patients with symptomatic PAD or a history of peripheral artery revascularization. However, antiplatelet monotherapy has not proven beneficial in patients with asymptomatic PAD. Dual antiplatelet therapy has not demonstrated a clear benefit in reducing the risk of cardiovascular events in patients with symptomatic PAD. Its role in reducing the risk of adverse limb events following endovascular or surgical revascularization also remains unclear. Recently, the use of vorapaxar in addition to aspirin and/or clopidogrel has been associated with a significant reduction in the need for repeat revascularization procedures and hospitalization for limb ischemia in patients with established PAD. SUMMARY: Eligible patients with symptomatic PAD or with a history of peripheral artery revascularization should be prescribed antiplatelet monotherapy for secondary prevention of both cardiovascular and limb events, using aspirin, clopidogrel, and/or vorapaxar. Given the significant overlap of PAD and coronary artery disease, the evidence presented in this article may have important implications for management of patients with coronary artery disease.

Comparison of dual-antiplatelet therapy durations after endovascular revascularization of infrainguinal arteries.

BACKGROUND: The optimal dual-antiplatelet therapy (DAPT) duration after endovascular revascularization of infrainguinal arteries is uncertain. METHODS: This study examines DAPT prescription trends and 12-month major adverse limb events (MALEs; a composite of repeat endovascular or surgical revascularization, acute vessel thrombosis, or amputation of the target limb), major adverse cardiovascular events (MACEs; all-cause mortality, nonfatal myocardial infarction [MI], stroke, or coronary revascularization), fatal bleeding events, and those requiring interruption or discontinuation of DAPT (hemorrhagic complications) for patients enrolled into the Excellence in Peripheral Artery Disease (XLPAD) registry. RESULTS: Data on 368 patients prescribed antiplatelet therapy were analyzed; 8.2% were prescribed antiplatelet monotherapy, 48.6% DAPT for ≤3 months, and 43.2% for >3 months. Patients in the >3 DAPT prescribed group were older, had preexisting coronary artery disease (CAD), and prior MI (all P < 0.001). Overall MALE in the ≤3 and >3-month DAPT prescribed groups were 22.3% and 23.9%, respectively (P = 0.541). Survival analysis showed significantly higher rates of MACE in patients prescribed >3-month DAPT (17.6% vs. 9.5%; P = 0.019). An "as-treated" analysis excluded 10 patients who were prescribed DAPT for >3 months and revealed similar rates of MALE (24.9% vs. 20.8%; P = 0.386) and MACE (12.2% vs. 14.8%; P = 0.443) in patients receiving ≤3 and >3 DAPT. Hemorrhagic complications were similar across all prescribed and "as-treated" DAPT groups. CONCLUSIONS: After infrainguinal endovascular procedures, patients with underlying CAD were prescribed longer (>3 months) duration of DAPT and experienced more cardiovascular events compared with those prescribed ≤3 months of DAPT. Adverse limb events were similar in both groups.

Comparative Assessment of Guidewire and Microcatheter vs a Crossing Device-Based Strategy to Traverse Infrainguinal Peripheral Artery Chronic Total Occlusions.

PURPOSE: To compare success rates of a guidewire and microcatheter strategy vs the use of specialized crossing devices to traverse infrainguinal peripheral artery chronic total occlusions (CTOs). METHODS: For this analysis, data on 438 consecutive infrainguinal CTO interventions in 438 patients (mean age 63.2 years; 402 men) performed between August 2006 and May 2014 were extracted from the multicenter Excellence in Peripheral Artery Disease (XLPAD) database (ClinicalTrials.gov; identifier NCT01904851). Primary technical success constituted placement of a guidewire in the true lumen, past the distal CTO cap, with the initial crossing strategy. RESULTS: A wire-catheter strategy was used in 295 (67.4%) and a specialized CTO crossing device in 143 (32.6%) patients (p<0.001). Primary crossing technical success was higher with CTO devices (72.1% vs 51.9%, p<0.001). The primary wire-catheter arm used significantly more secondary CTO devices (28.1% vs 17.5%) and/or provisional re-entry devices (26.7% vs 4.9%) compared with the primary CTO device arm (both p<0.001). Secondary crossing technical success (defined as crossing with an alternate strategy: 67.5% vs 71.4%, p=1.000), provisional crossing technical success (defined as use of a re-entry device: 84.2% vs 87.5%, p=0.768), and procedure success (93.6% vs 90.9%, p=0.332) were similar between the wire-catheter and CTO device strategies, respectively. No differences were observed in periprocedural complications or 30-day adverse events; however, at 12 months, there was a significantly higher surgical revascularization rate in the primary wire-catheter arm (8.8% vs 2.8%, p=0.025). CONCLUSION: Infrainguinal peripheral artery CTO crossing is frequently attempted with a wire-catheter technique; however, an initial CTO crossing device approach is associated with higher primary technical success. Overall procedure success is similar with both strategies.

Drug-coated balloon and stent therapies for endovascular treatment of atherosclerotic superficial femoral artery disease.

Endovascular management of superficial femoral artery disease has historically been limited to percutaneous balloon angioplasty, atherectomy, and bare-metal stents. However, these therapies have been plagued by high restenosis and target lesion revascularization rates. More recent technologies such as drug-coated stents and balloons are designed to combat restenosis by locally delivering antiproliferative drugs. Several randomized controlled trials have directly compared these antiproliferative drug-delivering devices to their non-drug-coated counterparts. Additionally, trials are currently ongoing to compare use of drug-coated technologies in combination with traditional therapies in hope of synergistic effects. This review gathers data from currently published clinical trials, provides an overview of upcoming clinical studies utilizing drug-coated technology, and explores the possible impact these devices may have on clinical practice.

Recanalization of popliteal and infrapopliteal chronic total occlusions using Viance and CrossBoss crossing catheters: a multicenter experience from the XLPAD Registry.

BACKGROUND: Chronic total occlusions (CTOs) are reported in up to 40% of patients with symptomatic peripheral arterial disease. The Viance Crossing catheter (Covidien) and the CrossBoss catheter (Boston Scientific) are novel devices that facilitate either true lumen or subintimal navigation across CTOs. The purpose of this study was to examine the acute procedural success of these devices for popliteal and below-the-knee (BTK) CTOs. METHODS: Clinical and procedural outcome data between Sept 2010 and October 2013 were analyzed from the ongoing multicenter XLPAD registry. Technical success was defined as true lumen passage of the catheter, while procedural success was defined as successful vessel revascularization inclusive of subintimal passage and reentry. RESULTS: Twenty-nine patients underwent 31 procedures, in which 37 lesions were treated with the Viance and CrossBoss catheters. Mean age of the group was 69.1 ± 10.7 years and 26 patients were male (90%). All patients (100%) had hypertension, 62% were diabetic, and 48% were active smokers. Critical limb ischemia was the indication for the procedure in 58% of cases; mean Rutherford class was 4.2 ± 1.2 for the entire cohort. Target CTOs included 14 anterior tibial, 9 posterior tibial, 5 peroneal, 1 tibio-peroneal trunk, and 8 popliteal artery lesions. Mean lesion length was 81 ± 64 mm; 15 lesions (41%) were severely calcified. True lumen passage was obtained in 24 lesions (65% technical success). Subintimal entry was achieved in 5 lesions (14%). Procedural success was achieved in 26 lesions (70%). Procedural failure was related to longer lesion length (P<.001), and mean length of failed lesions was 136 ± 65 mm. CONCLUSION: Viance and CrossBoss catheters were associated with an overall 70% procedural success with predominantly true lumen crossing in a BTK-CTO cohort. CTO length remains an important determinant of device success.

Stent and Non-Stent Based Outcomes of Infrainguinal Peripheral Artery Interventions From the Multicenter XLPAD Registry.

BACKGROUND: There are limited data regarding contemporary use of stent and non-stent based treatment strategies of infrainguinal peripheral artery disease (PAD). METHODS: We analyzed data from the ongoing multicenter XLPAD registry between July 2005 and October 2013 to report on the use of non-stent (atherectomy ± balloon angioplasty) and stent-based treatment of superficial femoral artery (SFA), popliteal, and below-the-knee (BTK) vessels in contemporary clinical practice. RESULTS: A total of 584 interventions (SFA, 82.5%; popliteal, 7.2%; BTK, 9.9%) were performed in 372 patients (mean age, 63.2 years; diabetes mellitus, 57.7%; Rutherford category 1-3, 73.5%; Rutherford category 4-6, 20.1%). Stents were deployed in 389 lesions (66.6%; SFA, 90.5%; popliteal, 5.1%; BTK, 4.1%) and non-stent strategy (atherectomy, 49%) in 195 lesions (33.4%; SFA, 66.7%; popliteal, 11.3%; BTK, 21.5%). In the stent and non-stent groups, mean lesion lengths were 133.9 mm and 86.0 mm (P<.001), chronic total occlusions (CTOs) constituted 63.0% and 49.7% (P<.01), and restenotic lesions were 12.6% and 32.3% (P<.001), respectively. At a mean follow-up of 260 ± 130 days, in the stent and non-stent treated patients, all-cause mortality was 4.3% and 3.5% (P=.65), clinically indicated repeat revascularization was 17.5% and 14.9% (P=.42), and amputation was 4.6% and 9.2% (P<.01), respectively. SFA lesion location, long lesion length, and CTO were associated with the use of stents. Advanced Rutherford class was associated with a non-stent treatment strategy. CONCLUSION: The majority of endovascular peripheral arterial interventions are performed in the SFA; most include a CTO and in patients with diabetes mellitus. Operators use stents to primarily treat complex SFA lesions with overall similar outcomes, except for fewer amputations compared to a non-stent strategy.

Effect of a real-time radiation monitoring device on operator radiation exposure during cardiac catheterization: the radiation reduction during cardiac catheterization using real-time monitoring study.

BACKGROUND: The Radiation Reduction During Cardiac Catheterization Using Real-Time Monitoring study sought to examine the effect of a radiation detection device that provides real-time operator dose reporting through auditory feedback (Bleeper Sv; Vertec Scientific Ltd; Berkshire, UK) on patient dose and operator exposure during cardiac catheterization. METHODS AND RESULTS: Between January 2012 and May 2014, 505 patients undergoing coronary angiography, percutaneous coronary intervention, or both were randomized to use (n=253) or no use (n=252) of the Bleeper Sv radiation monitor. Operator radiation exposure was measured in both groups using a second, silent radiation exposure monitoring device. Mean patient age was 65±8 years, most patients (99%) were men, and 30% had prior coronary artery bypass graft surgery. Baseline clinical characteristics were similar in the 2 study groups. Radial access was used in 18% and chronic total occlusion percutaneous coronary intervention constituted 7% of the total procedures. Median procedure time was 17 (12-27) minutes for diagnostic angiography, 42 (28-70) minutes for percutaneous coronary intervention, and 27 (14-51) minutes in the overall study population, with similar distribution between the study groups. First (9 [4-17] versus 14 [7-25] µSv; P<0.001) and second (5 [2-10] versus 7 [4-14] µSv; P<0.001) operator radiation exposure was significantly lower in the Bleeper Sv group. Use of the device did not result in a significant reduction in patient radiation dose. The effect of the Bleeper Sv device on operator radiation exposure was consistent among various study subgroups. CONCLUSIONS: Use of a real-time radiation monitoring device that provides auditory feedback can significantly reduce operator radiation exposure during cardiac catheterization. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01510353.

Crossing of infrainguinal peripheral arterial chronic total occlusion with a blunt microdissection catheter.

PURPOSE: Crossing of lower-extremity arterial chronic total occlusion (CTO) can be challenging. Use of the Viance peripheral CTO crossing device (Covidien) in the superficial femoral (SFA), popliteal, and below-the knee (BTK) arterial locations has received limited study. METHODS: Fifty-eight patients from the Excellence in Peripheral Artery Disease (XLPAD) registry (NCT01904851) were treated between April 2010 and November 2013 with the Viance device. The procedural and 30-day clinical outcomes were collected. RESULTS: Mean age was 65.5 ± 8.7 years and 55.1% had diabetes mellitus. Most lesions (n = 58) were TASC classification type C (n = 16; 27.6%) and D (n = 16; 27.6%), with mean lesion length 140.0 ± 71.0 mm; 93.1% of lesions were de novo and 81.0% were severely calcified. Technical success (crossing without the use of a reentry device) was achieved in 87.9% of cases and procedural success was obtained in 86.2%; 51.7% of lesions received stents, with the remaining treated with balloon angioplasty and/or atherectomy. Average fluoroscopy time was 39.1 ± 21.2 min, with 187.8 ± 72.0 mL of contrast and 210.0 ± 212.0 Gy cm² radiation dose-area product. There was 1 periprocedural complication (access-site hematoma treated conservatively without blood transfusion). At 30 days post procedure, there was significant improvement in ankle-brachial index (0.72 ± 0.30 to 0.84 ± 0.16; P=.01) and Rutherford class (3.33 ± 0.81 to 1.54 ± 1.47; P<.001). Clinically-indicated target vessel revascularization, surgical intervention or amputation at 30 days was 5.2%. CONCLUSION: Use of Viance to cross infrainguinal arterial CTO was associated with high success, low complication rates, and significant symptom improvement.

Drug delivering technology for endovascular management of infrainguinal peripheral artery disease.

Endovascular intervention has become a well-recognized treatment modality for peripheral artery disease; however, mid- and long-term outcomes have been plagued by limited durability. Plain balloon angioplasty and bare-metal stents have historically suffered from high restenosis rates leading to the need for frequent repeat revascularization procedures. The innovation of locally administered, drug-delivering balloons and stents has been a direct result of technological innovations directed toward prevention and treatment of this limitation. Over the last 5 years, numerous clinical trials investigating the use of drug-coated stents and drug-coated balloons indicate a significant improvement in endovascular treatment durability and outcomes. This review provides an up-to-date assessment of the current evidence for the use of drug-coated stents and drug-coated balloons in the treatment of femoropopliteal and infrapopliteal peripheral artery disease. Additionally, it provides an overview of the development of this technology, highlights landmark ongoing and completed clinical trials, examines evidence to support the use of drug-coated technologies in combination with other modalities, and examines promising new technological developments. Last, it summarizes the challenges and safety concerns that have delayed U.S. Food and Drug Administration approval of these devices.

Endovascular treatment of infrainguinal chronic total occlusions using the TruePath device: features, handling, and 6-month outcomes.

PURPOSE: To report experience with a recently approved peripheral chronic total occlusion (CTO) crossing device in the superficial femoral (SFA), popliteal, and below-the-knee (BTK) arteries. METHODS: Thirteen patients (all men; mean age 68.6±7.9 years) from the XLPAD registry (ClinicalTrials.gov identifier NCT01904851) were treated between April 2012 and August 2013 with the TruePath device after an unsuccessful guidewire crossing attempt. More than half of the patients had diabetes mellitus. Most lesions were TASC classification type C (n=5) or D (n=6), with mean lesion length 169.8±83.3 mm; 12 lesions were de novo and severely calcified. Procedure success was defined as successful revascularization of the CTO. Technical success was placement of a guidewire beyond the distal CTO cap into the true lumen without the need for a re-entry device. RESULTS: All CTOs were successfully crossed using the TruePath, but 3 subintimal recanalizations required the use of a re-entry device (77% technical success). Eight lesions were stented, while the remaining were treated with balloon angioplasty and/or atherectomy. Average fluoroscopy time was 41.1±18.3 minutes, during which a mean 200.0±46.2 mL of iodinated contrast were used (radiation dose area product 211.2±202.6 Gy*cm(2)). There were no periprocedural complications. Significant improvement was seen in the 6-month ankle-brachial index (p=0.018) and Rutherford class (p=0.019). The 6-month clinically indicated target vessel revascularization rate was 8%. CONCLUSION: TruePath facilitated successful crossing of infrainguinal CTOs following an unsuccessful guidewire recanalization, with significant improvement in symptoms and no complications.

Significance of an abnormal ankle-brachial index in patients with established coronary artery disease with and without associated diabetes mellitus.

An abnormal ankle-brachial index (ABI) is associated with higher risk for future cardiovascular (CV) events; however, it is unknown whether this association is true in patients with established coronary artery disease (CAD) and associated diabetes mellitus (DM). We evaluated 679 patients with stable CAD enrolled in the Excellence in Peripheral Arterial Disease and Veterans Affairs North Texas Healthcare System peripheral arterial disease databases. ABI and 12-month major adverse CV events (MACEs, a composite of all-cause death, nonfatal myocardial infarction, need for repeat coronary revascularization, and ischemic stroke) were assessed. Cox proportional hazard models were used to assess the association of ABI and DM with subsequent CV events. An abnormal ABI (<0.9 or >1.4) was present in 72% of patients with stable CAD and 68% had DM. Using patients without DM and normal ABI as reference, the adjusted hazard ratio for 12-month MACE was 1.7 (95% confidence interval [CI] 0.71 to 4.06) for patients with DM and normal ABI; 2.03 (95% CI 0.83 to 4.9) for patients without DM with abnormal ABI; and 4.85 (95% CI 2.22 to 10.61) for patients with DM and abnormal ABI. In conclusion, in patients with stable CAD, an abnormal ABI confers an incremental risk of MACE in addition to DM and traditional CV risk factors.

Blunt microdissection for endovascular treatment of infrainguinal chronic total occlusions.

PURPOSE: To present a systematic safety evaluation of the CrossBoss blunt microdissection catheter for crossing peripheral chronic total occlusions (CTOs). METHODS: Between July 2010 and July 2011, 15 patients (all men; mean age 60.7±9.1 years) underwent endovascular treatment of 17 infrainguinal CTOs that were resistant to guidewire passage, so the blunt microdissection catheter was employed to recanalize the artery. Fourteen lesions were de novo and 3 were in-stent restenoses. Sixteen lesions were in the superficial femoral artery; 8 of 17 CTOs were TASC II type D. Extensive calcification was present in 12 lesions. Mean lesion length was 182.9±66.2 mm (range 57-296). RESULTS: Procedural success was 100% and successful crossing without the use of a re-entry device (technical success) was achieved in 15 cases. Twelve lesions were stented. Average fluoroscopy time was 36.5±21.2 minutes (143.8±76.9 Gy*cm (2) radiaton dose area product), during which a mean 172.1±62.2 mL of iodinated contrast were used. Two patients had access site hematomas that were treated conservatively, and there was no perforation, distal embolization, amputation, or need for urgent revascularization. During the mean follow-up of 11.4±0.1 months, 1 patient died, and none required an amputation or surgical revascularization. There was a significant improvement in ankle-brachial index (0.6±0.1 to 0.8±0.2, p=0.001) and symptoms as assessed by Rutherford class at 1 year. Four of 17 limbs required secondary revascularization procedures within 1 year. CONCLUSION: The CrossBoss blunt microdissection catheter facilitated successful crossing of CTOs in patients with infrainguinal lesions following unsuccessful guidewire crossing, with an acceptably low rate of periprocedural complications and significant improvement in symptoms.