Mazen Abu-Fadel

Real-time ultrasound guidance facilitates femoral arterial access and reduces vascular complications: FAUST (Femoral Arterial Access With Ultrasound Trial).

OBJECTIVESnThe aim of this study was to compare the procedural and clinical outcomes of femoral arterial access with ultrasound (US) guidance with standard fluoroscopic guidance.nnnBACKGROUNDnReal-time US guidance reduces time to access, number of attempts, and complications in central venous access but has not been adequately assessed in femoral artery cannulation.nnnMETHODSnPatients (n = 1,004) undergoing retrograde femoral arterial access were randomized 1:1 to either fluoroscopic or US guidance. The primary end point was successful common femoral artery (CFA) cannulation by femoral angiography. Secondary end points included time to sheath insertion, number of forward needle advancements, first pass success, accidental venipunctures, and vascular access complications at 30 days.nnnRESULTSnCompared with fluoroscopic guidance, US guidance produced no difference in CFA cannulation rates (86.4% vs. 83.3%, p = 0.17), except in the subgroup of patients with CFA bifurcations occurring over the femoral head (82.6% vs. 69.8%, p < 0.01). US guidance resulted in an improved first-pass success rate (83% vs. 46%, p < 0.0001), reduced number of attempts (1.3 vs. 3.0, p < 0.0001), reduced risk of venipuncture (2.4% vs. 15.8%, p < 0.0001), and reduced median time to access (136 s vs. 148 s, p = 0.003). Vascular complications occurred in 7 of 503 and 17 of 501 in the US and fluoroscopy groups, respectively (1.4% vs. 3.4% p = 0.04).nnnCONCLUSIONSnIn this multicenter randomized controlled trial, routine real-time US guidance improved CFA cannulation only in patients with high CFA bifurcations but reduced the number of attempts, time to access, risk of venipunctures, and vascular complications in femoral arterial access. (Femoral Arterial Access With Ultrasound Trial [FAUST]; NCT00667381).

Clinical cardiac involvement in thrombotic thrombocytopenic purpura: a systematic review

BACKGROUND: Autopsy studies consistently demonstrate cardiac involvement in thrombotic thrombocytopenic purpura (TTP), but clinical evidence for cardiac abnormalities is rarely reported.

Effect of statin therapy on contrast-induced nephropathy after coronary angiography: A meta-analysis

BACKGROUNDnAlthough the pleiotropic effects of statins are postulated to be renoprotective, clinical studies have demonstrated conflicting results. We undertook a meta-analysis of published trials to evaluate the impact of statin therapy on the incidence of contrast-induced nephropathy (CIN) in patients undergoing coronary angiography.nnnMETHODSnWe searched MEDLINE and EMBASE databases through December 2010 for articles evaluating the effect of statins on the incidence of CIN in patients undergoing coronary angiography. Odds ratios (OR) with 95% confidence intervals (CI) were calculated using random effects modeling.nnnRESULTSnThree randomized controlled trials involving 770 patients (330 in the statin group and 340 in the control group) and 7 non-randomized studies involving 31,959 patients (11,936 statin-pretreated and 20,023 statin-naïve). The definition of CIN varied somewhat among the studies. Based on the pooled estimate across the 3 randomized controlled trials, statin therapy did not significantly reduce the incidence of CIN compared to control (OR=0.76, 95% CI: 0.41-1.41, p=0.39). No significant heterogeneity was found in the randomized studies (I(2)=0%, p=0.48). The pooled analysis of the non-randomized studies showed a marginally significant benefit associated with statin therapy (OR=0.60, 95% CI: 0.36-1.00, p=0.05). There was significant heterogeneity among the non-randomized studies (I(2)=88%, p<0.00001).nnnCONCLUSIONSnOur meta-analysis suggests that statin therapy might be associated with a significant reduction in the incidence of CIN in patients undergoing coronary angiography. Further studies are warranted to clarify this issue.

Fluoroscopy vs. Traditional guided femoral arterial access and the use of closure devices: A randomized controlled trial†

Objective: To compare the effectiveness of accessing the common femoral artery (CFA) using fluoroscopic guidance (FG) versus traditional anatomic landmark guidance (TALG) during cardiac catheterization and to determine the effect of the two modalities on the appropriateness for use of vascular closure devices (VCDs). Background: Previous studies have shown a consistent relationship between the head of the femur and the CFA, yet there is no prospective data validating the superiority of fluoroscopy‐assisted CFA access. Methods: A total of 972 patients were randomized to either FG or TALG access. The primary endpoint of the study was the angiographic suitability of the puncture site for VCD use. Secondary endpoints included arteriotomy location, time and number of attempts needed to obtain access, and the incidence of vascular complications. Results: Of these, 474 patients were randomized into the FG arm and 498 patients into the TALG arm. A total of 79.5% of patients in the fluoroscopy arm and 80.7% in the traditional arm (P = 0.7) were deemed angiographically suitable for VCD based on the arteriotomy. The fluoroscopy group had significantly less arteriotomies below the inferior border of the head of the femur (P = 0.03). Total time for sheath insertion (105.7 ± 130.7 vs. 106.5 ± 152.6 sec) and number of arterial punctures (1.1 ± 0.4 vs. 1.1 ± 0.5) did not differ among the FG and TALG, respectively. The rates of vascular complications were not different. Conclusion: The angiographic suitability for VCD was not different between FG and TALG groups. Fluoroscopy decreased the number of low arteriotomies. The time to sheath insertion, number of arterial punctures needed to obtain access, and the incidence of complications were also similar.

Real-time ultrasound guidance facilitates transradial access: RAUST (Radial Artery access with Ultrasound Trial).

OBJECTIVESnThis study sought to assess the utility of ultrasound (US) guidance for transradial arterial access.nnnBACKGROUNDnUS guidance has been demonstrated to facilitate vascular access, but has not been tested in a multicenter randomized fashion for transradial cardiac catheterization.nnnMETHODSnWe conducted a prospective multicenter randomized controlled trial of 698 patients undergoing transradial cardiac catheterization. Patients were randomized to needle insertion with either palpation or real-time US guidance (351 palpation, 347 US). Primary endpoints were the number of forward attempts required for access, first-pass success rate, and time to access.nnnRESULTSnThe number of attempts was reduced with US guidance [mean: 1.65 ± 1.2 vs. 3.05 ± 3.4, p < 0.0001; median: 1 (interquartile range [IQR]: 1 to 2) vs. 2 (1 to 3), p < 0.0001] and the first-pass success rate improved (64.8% vs. 43.9%, p < 0.0001). The time to access was reduced (88 ± 78 s vs. 108 ± 112 s, p = 0.006; median: 64 [IQR: 45 to 94] s vs. 74 [IQR: 49 to 120] s, p = 0.01). Ten patients in the control group required crossover to US guidance after 5 min of failed palpation attempts with 8 of 10 (80%) having successful sheath insertion with US. The number of difficult access procedures was decreased with US guidance (2.4% vs. 18.6% for ≥5 attempts, p < 0.001; 3.7% vs. 6.8% for ≥5min, p = 0.07). No significant differences were observed in the rate of operator-reported spasm, patient pain scores following the procedure, or bleeding complications.nnnCONCLUSIONSnUltrasound guidance improves the success and efficiency of radial artery cannulation in patients presenting for transradial catheterization. (Radial Artery Access With Ultrasound Trial [RAUST]; NCT01605292).

Pilot Trial of Cryoplasty or Conventional Balloon Post-Dilation of Nitinol Stents for Revascularization of Peripheral Arterial Segments: The COBRA Trial

OBJECTIVESnThe 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.nnnBACKGROUNDnEndovascular 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.nnnMETHODSnWe 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.nnnRESULTSnSeventy-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).nnnCONCLUSIONSnAmong 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).

Comparison of prasugrel and clopidogrel in patients with acute coronary syndrome undergoing percutaneous coronary intervention

Antiplatelet agents are the cornerstone of treatment for patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). Clopidogrel, when added to aspirin, has demonstrated considerable success at reducing thrombotic complications of ACS and/or PCI compared to aspirin alone and is standard of care for the management of patients with ACS and in patients undergoing PCI. Prasugrel is a novel thienopyridine antiplatelet agent recently approved for the treatment of patients with ACS undergoing PCI. Prasugrel provides greater and more consistent platelet inhibition than clopidogrel due to earlier and more extensive formation of its active metabolite. The enhanced platelet inhibition with prasugrel led to a reduction in major adverse cardiovascular events in patients with moderate to high risk ACS scheduled for PCI in the phase 3 TRITON-TIMI 38 trial. This benefit was seen more in patients suffering a STEMI and those with diabetes. However, this reduction in events was met with a significant increase in the risk of bleeding which overcame prasugrel’s benefit in certain groups. Future studies with prasugrel are needed to determine its optimal utilization to minimize bleeding risks and evaluate its outcomes in ACS and safety profile in special patient populations.

Comparison of radiation dose between different fluoroscopy systems in the modern catheterization laboratory: Results from bench testing using an anthropomorphic phantom

Variations in radiation dose between various X‐ray systems have received limited study.

Hemorrhagic and Ischemic Outcomes After Bivalirudin Versus Unfractionated Heparin During Carotid Artery Stenting A Propensity Score Analysis From the NCDR

Background—The direct thrombin inhibitor, bivalirudin, is associated with similar efficacy and superior safety in patients undergoing percutaneous coronary intervention. However, the role of direct thrombin inhibitors in carotid artery stenting is not well defined. The objective of this study was to compare the safety and effectiveness of bivalirudin and unfractionated heparin (UFH) for carotid artery stenting. We hypothesized that bivalirudin would be associated with less in-hospital postprocedure bleeding than UFH but similar rates of in-hospital and 30-day ischemic outcomes. Methods and Results—We compared the incidence of in-hospital hemorrhagic and in-hospital/30-day ischemic outcomes among patients in the CARE Registry who underwent carotid artery stenting between May 2005 and March 2012 using bivalirudin or UFH. Propensity score matching was used to obtain a balanced cohort of 3555 patients in each treatment group. Patients treated with bivalirudin had a significantly lower incidence of bleeding or hematoma requiring red blood cell transfusions (0.9% versus 1.5%; odds ratio, 0.57 [0.36–0.89]; P=0.01) when compared with UFH-treated patients. The incidence of in-hospital and 30-day ischemic outcomes, including death, myocardial infarction, stroke, transient ischemic attack, and the composite outcome, death/myocardial infarction/stroke, did not differ significantly between groups. Conclusions—Bivalirudin was associated with lower rates of hemorrhagic outcomes compared with UFH during the index hospitalization for carotid artery stenting. In-hospital and 30-day ischemic events were similar between the 2 groups. Randomized comparisons of these agents are needed to confirm these findings.

Endovascular treatment of mesenteric ischemia

Objectives: Our goal was to describe a single‐centers experience in managing acute and chronic mesenteric ischemia with endovascular therapies.