Thomas A. Hennebry

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

OBJECTIVES The aim of this study was to compare the procedural and clinical outcomes of femoral arterial access with ultrasound (US) guidance with standard fluoroscopic guidance. BACKGROUND Real-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. METHODS Patients (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. RESULTS Compared 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). CONCLUSIONS In 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).

Bivalirudin and Clopidogrel With and Without Eptifibatide for Elective Stenting: Effects on Platelet Function, Thrombelastographic Indexes, and Their Relation to Periprocedural Infarction: Results of the CLEAR PLATELETS-2 (Clopidogrel With Eptifibatide to Arrest the Reactivity of Platelets) Study

OBJECTIVES The primary objective of this study was to compare the effect of therapy with bivalirudin alone versus bivalirudin plus eptifibatide on platelet reactivity measured by turbidometric aggregometry and thrombin-induced platelet-fibrin clot strength (TIP-FCS) measured by thrombelastography in percutaneous coronary intervention (PCI) patients. The secondary aim was to study the relation of platelet aggregation and TIP-FCS to the occurrence of periprocedural infarction. BACKGROUND Bivalirudin is commonly administered alone to clopidogrel naïve (CN) patients and to patients on maintenance clopidogrel therapy (MT) undergoing elective stenting. The effect of adding eptifibatide to bivalirudin on platelet reactivity (PR) and TIP-FCS, and their relation to periprocedural infarction in these patients are unknown. METHODS Patients (n = 200) stratified to clopidogrel treatment status were randomly treated with bivalirudin (n = 102) or bivalirudin plus eptifibatide (n = 98). One hundred twenty-eight CN patients were loaded with 600 mg clopidogrel immediately after stenting, and 72 MT patients were not loaded. The PR, TIP-FCS, and myonecrosis markers were serially determined. RESULTS In CN and MT patients, bivalirudin plus eptifibatide was associated with markedly lower PR at all times (5- and 20-microM adenosine diphosphate-induced, and 15- and 25-microM thrombin receptor activator peptide-induced aggregation; p < 0.001 for all) and reduced mean TIP-FCS (p < 0.05). Patients who had a periprocedural infarction had higher mean 18-h PR (p < 0.0001) and TIP-FCS (p = 0.002). CONCLUSIONS For elective stenting, the addition of eptifibatide to bivalirudin lowered PR to multiple agonists and the tensile strength of the TIP-FCS, 2 measurements strongly associated with periprocedural myonecrosis. Future studies of PR and TIP-FCS for elective stenting may facilitate personalized antiplatelet therapy and enhance the selection of patients for glycoprotein IIb/IIIa blockade. (Peri-Procedural Myocardial Infarction, Platelet Reactivity, Thrombin Generation, and Clot Strength: Differential Effects of Eptifibatide + Bivalirudin Versus Bivalirudin [CLEAR PLATELETS-2]; NCT00370045.

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

BACKGROUND Although 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. METHODS We 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. RESULTS Three 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). CONCLUSIONS Our 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.

Clinical cardiac involvement in idiopathic inflammatory myopathies: A systematic review

BACKGROUND Idiopathic inflammatory myopathies (IIM) presenting with diffuse skeletal muscular inflammation and cardiac involvement is one of the major causes of clinical deterioration. Our purpose was to observe the frequency of various reported clinical cardiac afflictions, cardiovascular mortality and its most important contributors in the IIM population. METHODS MEDLINE database was searched from 1977 through 2009. Articles reporting objective evidence of cardiac involvement were assessed. Patients were included if they satisfied Bohan and Peter criteria for definite or probable diagnosis of IIM. The review conforms to the criteria of the new PRISMA statement of preferred reporting items for systematic reviews and meta-analyses. RESULTS Thirty-three out of 90 articles reported cardiac data. Twelve were case reports, while 21 articles were either cohort studies or case series. Angina was reported in 7% of cumulative prospective cohort. Dysrhythmias were seen in 31.8% of electrocardiograms. Diastolic dysfunction was the most common echocardiographic finding. Congestive heart failure was reported in 5.6% of the prospective cohort and was the most common cause of death accounting for 21% of total cardiac mortality. Myocarditis was the most common feature in reported pathology literature (38%), followed by focal myocardial fibrosis (22%). CONCLUSION Cardiac involvement is an important cause of morbidity and mortality in patients with IIM. Myocardial fibrosis puts the patient at risk for systolic or diastolic heart failure and dysrhythmias. This review, therefore, suggests the importance of early and comprehensive cardiac evaluation in IIM population. Confirmation of these findings will require prospective studies of consecutive patients with long-term follow-up.

Periprocedural Myocardial Infarction: Review and Classification

Technical and pharmacologic advances have reduced the occurrence of large periprocedural myocardial infarction (PMI) after percutaneous coronary interventions (PCI), but PMI still occurs in 6% to 18% of the cases and is associated with impaired short‐ and long‐term survival. PMI might be due to side branch closure or flow‐limiting dissection, but is most often diagnosed after apparently uncomplicated PCI and is due to atheroembolization into the microcirculation. Various definitions of PMI are used in clinical trials, but a rise in creatine kinase‐MB greater than 3 to 8 times the upper limit of normal is consistently associated with worse prognosis, particularly as it reflects a more extensive and unstable atherosclerotic burden. On the other hand, data regarding the independent prognostic value of periprocedural troponin increase are conflicting. Some data suggest that PMI has a better prognosis than a spontaneously occurring myocardial infarction, and that its incidence is reduced with aggressive antiplatelet and statin therapy. Copyright

Drug eluting versus bare metal stents in cardiac allograft vasculopathy

Background: Cardiac allograft vasculopathy (CAV) is a distinct pathological condition characterized by diffuse and progressive arteriopathy and it is an important determinant of long‐term graft survival. Definitive CAV treatment is retransplantation but palliation with stenting might temporarily alleviate it. The benefit of drug eluting stents (DES) over bare metal stents (BMS) in the treatment of such lesions is debatable. We therefore sought to do a literature search to review the available evidence comparing DES to BMS. Methods: We conducted Pub Med, EMBASE, Cochrane database review, Web of Science search of studies comparing DES with BMS in CAV. Available studies were retrospective in nature with either direct comparison groups (n = 5) or historical controls (n = 1). The main outcomes analyzed were in stent restenosis (ISR) during follow‐up and clinical outcomes. Results: A total of 312 patients from six studies were included in the review (1995–2007). Most commonly used DES were sirolimus eluting stent. DES appeared to reduce the long‐term risk of ISR compared with BMS. Three of the five studies showed a statistically significant reduction in ISR at 12 months while the one study assessing ISR at 6 months showed no significant difference. Clinical endpoints such as death and major adverse cardiac events were not statistically different. Conclusion: DES appear to reduce the incidence of ISR in CAV as compared with BMS. Prospective randomized clinical trials are needed to determine the clinical benefit of DES beyond a reduction in ISR.

Transcatheter Aortic Valve Replacement: A Potential Option for the Nonsurgical Patient

With improved life expectancy, the incidence of aortic stenosis is rising. However, up to one‐third of patients who require lifesaving surgical aortic valve replacement are denied surgery due to a high operative mortality rate. Such patients can only be treated with medical therapy or percutaneous aortic valvuloplasty, neither of which has been shown to improve mortality. With advances in interventional cardiology, transcatheter methods have been developed for aortic valve replacement. Clinical trials are investigating these devices in patients with severe aortic stenosis that have been denied surgery. Preliminary results from these trials suggest that transcatheter aortic valve replacement (TAVR) is not only feasible, but an effective way to improve symptoms. In this review, we describe the current technology and display available outcome data. Though technical challenges and operator learning curve limit optimal use of the current technology, continued experience and advancements in technology may one day make TAVR a viable alternative to traditional surgical aortic valve replacement. Copyright

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.

Pharmacomechanical Thrombolysis of Acute and Chronic Symptomatic Deep Vein Thrombosis: A Systematic Review of Literature:

Pharmacomechanical thrombolysis (PMT) is an emerging treatment option for symptomatic deep vein thrombosis (DVT). This may obviate the need for systemic or catheter-directed thrombolysis. PubMed, EMBASE, and Cochrane database search of PMT in acute and chronic symptomatic DVT was undertaken. Baseline demographic and clinical characteristics, procedural details, DVT characteristics, and procedural and clinical outcomes are presented. A total of 8 case series (n = 2528; 1998-2009) qualified for inclusion. Lower extremity symptomatic DVTs constituted the majority of the cases (>80%). Both acute (<14 days) and chronic (>14 days) DVTs were included. Procedural success was 59% to 100% and catheter-directed thrombolysis was used as an adjunct in 16% to 53%. No deaths or major bleeding complications were reported. Pharmacomechanical thrombolysis leads to the immediate resolution of clinical symptoms of DVT in the majority of patients. Pharmacomechanical thrombolysis may be a safe and novel method, when appropriate expertise and resources are available, for the treatment of symptomatic acute and chronic DVT.