Ultrasound-Guided Transfemoral Access for Coronary Procedures: A Pooled Learning Curve Analysis From the FAUST and UNIVERSAL Trials.

BACKGROUND: The learning curve for new operators performing ultrasound-guided transfemoral access (TFA) remains uncertain. METHODS: We performed a pooled analysis of the FAUST (Femoral Arterial Access With Ultrasound Trial) and UNIVERSAL (Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures) trials, both multicenter randomized controlled trials of 1:1 ultrasound-guided versus non-ultrasound-guided TFA for coronary procedures. Outcomes included the composite of major bleeding or vascular complications and successful common femoral artery cannulation. Participants were stratified by the operators' accrued case volume. We used adjusted repeated-measurement logistic regression, with random intercepts for operator clustering, for comparison against the non-ultrasound-guided TFA group and to model the learning curve. RESULTS: The FAUST and UNIVERSAL trials randomized a total of 1624 patients, of which 810 were randomized to non-ultrasound-guided TFA and 814 to ultrasound-guided TFA (cases 1-10, 391; 11-20, 183; and >20, 240). Participants who had operators who performed >20 ultrasound-guided TFAs had a decreased risk for the primary end point (5/240 [2.1%] versus 64/810 [7.9%]; adjusted odds ratio, 0.26 [95% CI, 0.09-0.61]) compared with non-ultrasound-guided TFA. Operators who performed >20 ultrasound-guided procedures had increased odds of successfully cannulating the common femoral artery (224/246 [91.1%] versus 327/382 [85.6%]; adjusted odds ratio, 1.76 [95% CI, 1.08-2.89]) compared with non-ultrasound-guided TFA. The learning curve plots demonstrated growing competence with increasing accrued cases. CONCLUSIONS: New operators should perform at least 20 ultrasound-guided TFA to decrease access site complications and increase proper cannulation compared with non-ultrasound-guided TFA. Additional accrued cases may lead to increased proficiency. Training programs should consider these findings in the transradial era.

Ultrasound guidance for transfemoral access in coronary procedures: an individual participant-level data metaanalysis from the femoral ultrasound trialist collaboration.

BACKGROUND: Randomised controlled trials of ultrasound (US)-guided transfemoral access (TFA) for coronary procedures have shown mixed results. AIMS: We aimed to compare US-guided versus non-US-guided TFA from randomised data in an individual participant-level data (IPD) meta-analysis. METHODS: We completed a systematic review and an IPD meta-analysis of all randomised controlled trials comparing US-guided versus non-US-guided TFA for coronary procedures. We performed a one-stage mixed-model meta-analysis using the intention-to-treat population from included trials. The primary outcome was a composite of major vascular complications or major bleeding within 30 days. RESULTS: A total of 2,441 participants (1,208 US-guided, 1,233 non-US-guided) from 4 randomised clinical trials were included. The mean age was 65.5 years, 27.0% were female, and 34.5% underwent a percutaneous coronary intervention. The incidence of major vascular complications or major bleeding (34/1,208 [2.8%] vs 55/1,233 [4.5%]; odds ratio [OR] 0.61, 95% confidence interval [CI]: 0.39-0.94; p=0.026) was lower in the US-guided TFA group. In the prespecified subgroup of participants who received a vascular closure device, those randomised to US-guided TFA experienced a reduction in the primary outcome (2.1% vs 5.6%; OR 0.36, 95% CI: 0.19-0.69), while no benefit for US guidance was observed in the subgroup without vascular closure devices (4.1% vs 3.3%; OR 1.21, 95% CI: 0.65-2.26; interaction p=0.009). CONCLUSIONS: In participants undergoing coronary procedures by TFA, US guidance decreased the composite outcome of major vascular complications or bleeding and may be especially helpful when using vascular closure devices.

In-Hospital Outcomes and Trends of Endovascular Intervention vs Surgical Revascularization in Octogenarians With Peripheral Artery Disease.

It is unknown whether endovascular intervention (EVI) is associated with superior outcomes when compared with surgical revascularization in octogenarian. National Inpatient Sample (NIS) database was used to compare the outcomes of limb revascularization in octogenarians who had surgical revascularization versus EVI. The NIS database's information on PAD patients ≥80-year-old who underwent limb revascularization between 2002 and 2014 included 394,504 octogenarian patients, of which 184,926 underwent surgical revascularization (46.9%) and 209,578 underwent EVI (53.1%). Multivariate analysis was performed to examine in-hospital outcomes. Trend over time in limb revascularization utilization was examined using Cochrane-Armitage test. EVI group had lower odds of in-hospital mortality (adjusted odds ratio [aOR]: 0.61 [95% CI: 0.58 to 0.63], myocardial infarction (aOR: 0.84 [95% CI: 0.81 to 0.87]), stroke (aOR: 0.93 [95% CI: 0.89 to 0.96]), acute kidney injury (aOR: 0.79 [95% CI: 0.77 to 0.81]), and limb amputation (aOR: 0.77 [95% CI: 0.74 to 0.79]) compared with surgical group (p < 0.001 for all). EVI group had higher risk of bleeding (aOR: 1.20 [95% CI: 1.18 to 1.23]) and vascular complications (3.2% vs 2.7%, aOR: 1.25 [95% CI: 1.19 to 1.30]) compared with surgical group (p < 0.001 for all). Within study period, EVI utilization increased in octogenarian patients from 2.6% to 8.9% (ptrend < 0.001); whereas use of surgical revascularization decreased from 11.6% to 5.2% (ptrend < 0.001). In conclusion, the utilization of EVI in octogenarians is increasing, and associated with lower risk of in-hospital mortality and adverse cardiovascular and limb outcomes as compared with surgical revascularization.

Plaque Regression and Endothelial Progenitor Cell Mobilization With Intensive Lipid Elimination Regimen (PREMIER).

BACKGROUND: Low-density lipoproteins (LDLs) are removed by extracorporeal filtration during LDL apheresis. It is mainly used in familial hyperlipidemia. The PREMIER trial (Plaque Regression and Progenitor Cell Mobilization With Intensive Lipid Elimination Regimen) evaluated LDL apheresis in nonfamilial hyperlipidemia acute coronary syndrome patients treated with percutaneous coronary intervention. METHODS: We randomized 160 acute coronary syndrome patients at 4 Veterans Affairs centers within 72 hours of percutaneous coronary intervention to intensive lipid-lowering therapy (ILLT) comprising single LDL apheresis and statins versus standard medical therapy (SMT) with no LDL apheresis and statin therapy alone. Trial objectives constituted primary safety and primary efficacy end points and endothelial progenitor cell colony-forming unit mobilization in peripheral blood. RESULTS: Mean LDL reduction at discharge was 53% in ILLT and 17% in SMT groups (P<0.0001) from baseline levels of 116.3±34.3 and 110.7±32 mg/dL (P=0.2979), respectively. The incidence of the primary safety end point of major peri-percutaneous coronary intervention adverse events was similar in both groups (ILLT, 3; SMT, 0). The primary efficacy end point, percentage change in total plaque volume at 90 days by intravascular ultrasound, on average decreased by 4.81% in the ILLT group and increased by 2.31% in the SMT group (difference of means, -7.13 [95% CI, -14.59 to 0.34]; P=0.0611). The raw change in total plaque volume on average decreased more in the ILLT group than in the SMT group (-6.01 versus -0.95 mm3; difference of means, -5.06 [95% CI, -11.61 to 1.48]; P=0.1286). Similar results were obtained after adjusting for participating sites, age, preexisting coronary artery disease, diabetes mellitus, baseline LDL levels, and baseline plaque burden. There was robust endothelial progenitor cell colony-forming unit mobilization from baseline to 90 days in the ILLT group (P=0.0015) but not in SMT (P=0.0844). CONCLUSIONS: PREMIER is the first randomized clinical trial to demonstrate safety and a trend for early coronary plaque regression with LDL apheresis in nonfamilial hyperlipidemia acute coronary syndrome patients treated with percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01004406 and NCT02347098.

Coronavirus Disease 2019 Catheterization Laboratory Survey.

Background The coronavirus disease 2019 pandemic is expected to affect operations and lifestyles of interventional cardiologists around the world in unprecedented ways. Timely gathering of information on this topic can provide valuable insight and improve the handling of the ongoing and future pandemic outbreaks. Methods and Results A survey instrument developed by the authors was disseminated via e-mail, text messaging, WhatsApp, and social media to interventional cardiologists between April 6, 2020, and April 11, 2020. A total of 509 responses were collected from 18 countries, mainly from the United States (51%) and Italy (36%). Operators reported significant decline in coronary, structural heart, and endovascular procedure volumes. Personal protective equipment was available to 95% of respondents; however FIT-tested N95 or equivalent masks were available to only 70%, and 74% indicated absence of coronavirus disease 2019 pretesting. Most (83%) operators expressed concern when asked to perform cardiac catheterization on a suspected or confirmed coronavirus disease 2019 patient, primarily because of fear of viral transmission (88%). Although the survey demonstrated significant compliance with social distancing, high use of telemedicine (69%), and online education platforms (80%), there was concern over impending financial loss. Conclusions Our survey indicates significant reduction in invasive procedure volumes and concern for viral transmission. There is near universal adoption of personal protective equipment; however, coronavirus disease 2019 pretesting and access to FIT-tested N95 masks is suboptimal. Although there is concern over impending financial loss, substantial engagement in telemedicine and online education is reported.

Early vs Late Discharge in Low-Risk ST-Elevation Myocardial Infarction Patients Treated With Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis.

BACKGROUND: For low-risk patients with ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI) the recommended optimal discharge timing is inconsistent in guidelines. The European Society of Cardiology guidelines recommend early discharge within 48-72 h, while the American College of Cardiology guidelines do not recommend a specific discharge strategy. In this systematic review and meta-analysis we compared outcomes with early discharge (≤3 days) versus late discharge (>3 days). METHODS: Randomized controlled trials (RCTs) and observational studies were selected after searching MEDLINE and EMBASE database. Meta-analysis was stratified according to study design. Outcomes were reported as random effects risk ratios (RR) with 95% confidence intervals. RESULTS: Seven RCTs comprising 1780 patients and 4 observational studies comprising 39,288 patients were selected. The RCT-restricted analysis did not demonstrate significant differences in terms of all-cause mortality (RR, 0.97 [0.23-4.05]) and major adverse cardiac events (MACE) (RR, 0.84 [0.56-1.26]). Conversely, observational study restricted analysis showed that early vs late discharge strategy was associated with a reduction in all-cause mortality (RR, 0.40 [0.23-0.71]) and MACE (RR, 0.45 [0.26-0.78]). There were no significant differences in hospital readmissions between early vs late discharge in both RCT or observational study analyses. CONCLUSIONS: Early discharge strategy in appropriately selected low-risk patients with STEMI undergoing PCI is safe and it has the potential to improve cost of care.

Clinical Outcomes and Cost Comparisons of Stent and Non-Stent Interventions in Infrainguinal Peripheral Artery Disease: Insights From the Excellence in Peripheral Artery Disease (XLPAD) Registry.

BACKGROUND: The contemporary limb outcomes and costs of stent-based vs non-stent based strategies in endovascular revascularization of femoropopliteal (FP) peripheral artery disease (PAD) are not well understood. METHODS AND RESULTS: We present data from the ongoing United States multicenter Excellence in Peripheral Artery Disease Registry between 2006-2016 to compare stent vs non-stent treatment outcomes and associated costs in FP interventions. A total of 2910 FP interventions were performed in 2162 patients (mean age, 66 years), comprising 1339 stent based (superficial femoral artery, 93%) in 1007 patients and 1571 non-stent interventions (superficial femoral artery, 85%) in 1155 patients. A growing trend for non-stent based interventions and a declining trend in repeat revascularization rate at 1 year were observed across years of registry enrollment. Stent implantation was the prevailing strategy in treating longer FP lesions (mean length, 152 mm vs 105 mm; P<.001) and chronic total occlusions (65% vs 40%; P<.001), while stent implantation was employed less frequently when treating in-stent restenotic lesions (14% vs 20%; P<.001). Stent and non-stent interventions had similar 1-year limb outcomes in all-cause death, target-limb revascularization, target-vessel revascularization, and major or minor amputation. The average procedure costs for the stent group were significantly higher than the non-stent group ($6215 vs $4790; P<.001). CONCLUSION: There is a growing trend for non-stent FP artery interventions, with a significant decline in 1-year target-limb revascularization rates over time. One-year limb outcomes in stent-based compared to non-stent interventions are similar; however, at a significantly higher procedural cost.

Atherectomy in below-the-knee endovascular interventions: One-year outcomes from the XLPAD registry.

BACKGROUND: Use of atherectomy for the treatment of peripheral arterial disease (PAD) is increasing as an adjunctive treatment to either conventional or drug-coated balloon angioplasty. There is limited data on atherectomy outcomes in below-the-knee (BTK) endovascular interventions. METHODS: Data from the multicenter Excellence in Peripheral Artery Disease (XLPAD) registry (NCT01904851) were analyzed to examine predictors of atherectomy use and its associated 1-year patency rate. We analyzed 518 BTK procedures performed between January 2005 and December 2016. RESULTS: Overall a total of 518 BTK procedures were treated in 430 patients, and 43% of interventions used atherectomy. African American patients were less likely (13% vs 25%; |standard residual| = 3.41) to be treated with atherectomy. Use of atherectomy was lower in chronic total occlusive (CTO) lesions (48% vs 58%; P = 0.02). There were no significant associations of baseline comorbidities, critical limb ischemia (CLI), ankle-brachial index, number of BTK vessel run-off, or vessel location with atherectomy use. Compared with patients without atherectomy, use of atherectomy was associated with lower incidence of repeat target limb intervention at 1 year after adjusting for age, CLI, in-stent restenosis, heavy calcification, presence of diffuse disease, and CTO lesion traits (Hazard Ratio 0.41, 95% confidence interval 0.23-0.72; P < 0.01). CONCLUSIONS: Compared with no atherectomy, use of atherectomy in BTK interventions is associated with lower rates of 1-year repeat target limb revascularization. These findings require confirmation in prospective, randomized clinical studies.

Endovascular Stenting in 2 Patients with Benign Superior Vena Cava Syndrome.

Superior vena cava syndrome has typically been associated with malignant conditions; however, the number of benign cases has started to grow as the use of upper-extremity venous lines and implantable cardiac devices increases. Whereas endovascular techniques are standardly used to treat patients with malignancies, the optimal care of patients with benign causes is less clear because they typically have longer life expectancies. We describe 2 cases of benign superior vena cava syndrome successfully managed with endovascular stenting, and we review the relevant literature. Of 145 cases in 10 series (average follow-up time, 24 mo), 96% of patients experienced symptomatic relief after endovascular management, with a primary patency rate of 66% and a secondary rate of 93%. Although few data exist to compare open surgical and endovascular techniques directly, both approaches appear to produce similar rates of patency. Both approaches frequently necessitate secondary intervention to maintain patency, but endovascular management is associated with fewer complications. We conclude that endovascular management of benign superior vena cava syndrome is a safe, effective, and reasonable initial management approach.

Comparative Effectiveness Study of Drug-Eluting and Bare-Metal Peripheral Artery Stents in Endovascular Femoropopliteal Artery Revascularization.

OBJECTIVES: Paclitaxel drug-eluting stents (DESs) have been shown to improve primary patency of femoropopliteal lesions compared to plain balloon angioplasty with provisional bare-metal stents (BMSs) in randomized controlled studies. However, data are lacking on patency outcomes of real-world DES use relative to BMS use. This study compared clinically driven target-lesion revascularization (TLR), target-vessel revascularization (TVR), and target-limb revascularization outcomes at 1 year between DES and BMS treatments in a real-world setting. METHODS: The study identified 174 DES (Zilver PTX; Cook Medical) and 784 BMS femoropopliteal interventions from the available 969 Excellence in Peripheral Artery Disease (XLPAD) registry patients between October 2013 and December 2016. We analyzed both unmatched (174 DES and 784 BMS) and propensity score (PS)-matched datasets (174 for each). RESULTS: This study found that patients who underwent DES femoropopliteal endovascular revascularization had significantly lower TLR rates in both unmatched (hazard ratio [HR], 0.57; 95% confidence interval [CI], 0.35-0.91; P=.02) and matched data (HR, 0.50 95% CI, 0.27-0.91; P=.02). The DES group had a 43% lower TVR risk than the BMS group in the PS matched cohort (HR, 0.57; 95% CI, 0.33-0.98; P=.04). Mortality rate in the DES group (5%) was significantly higher than the BMS group in both unmatched (2%; P=.04) and matched groups (1%; P=.046) at 1 year. CONCLUSIONS: Patients treated with DES had higher lesion and vessel patency than BMS after adjusting for confounding, which included complexity of lesion characteristics and operators' clinical decision-making regarding selection of treatment modalities, in femoropopliteal endovascular interventions in a real-world registry.

Length of stay following percutaneous coronary intervention: An expert consensus document update from the society for cardiovascular angiography and interventions.

Since the publication of the 2009 SCAI Expert Consensus Document on Length of Stay Following percutaneous coronary intervention (PCI), advances in vascular access techniques, stent technology, and antiplatelet pharmacology have facilitated changes in discharge patterns following PCI. Additional clinical studies have demonstrated the safety of early and same day discharge in selected patients with uncomplicated PCI, while reimbursement policies have discouraged unnecessary hospitalization. This consensus update: (1) clarifies clinical and reimbursement definitions of discharge strategies, (2) reviews the technological advances and literature supporting reduced hospitalization duration and risk assessment, and (3) describes changes to the consensus recommendations on length of stay following PCI (Supporting Information Table S1). These recommendations are intended to support reasonable clinical decision making regarding postprocedure length of stay for a broad spectrum of patients undergoing PCI, rather than prescribing a specific period of observation for individual patients.

Unilateral Acute Renal Artery Embolism: An Index Case of Successful Mechanical Aspiration Thrombectomy With Use of Penumbra Indigo Aspiration System and a Review of the Literature.

Acute renal artery embolism (RAE) is a rare condition associated with significant morbidity and mortality. The treatment strategy for RAE includes anticoagulation with or without thrombolysis or surgical or endovascular embolectomy. We describe here a case presentation of acute RAE secondary to atrial fibrillation treated successfully with Penumbra Indigo Aspiration System, a novel device in peripheral endovascular interventions. Our patient had ongoing symptoms and acute renal failure on presentation with contraindication to thrombolysis given hypertensive emergency. A 6F Penumbra Aspiration catheter was used to aspirate large amounts of thrombus from segmental renal arteries with restoration of flow. Patient's symptoms and renal function returned to baseline after intervention. Penumbra system is used routinely in cerebral endovascular intervention, yet here we describe its potential use in peripheral vascular interventions in addition to a literature review of all available evidence for the different treatment modalities of acute RAE.

Fractional flow reserve versus angiography guided percutaneous coronary intervention: An updated systematic review.

OBJECTIVES: To compare outcomes of fractional flow reserve (FFR) to angiography (ANGIO) guided percutaneous coronary intervention (PCI). BACKGROUND: The results of a recent randomized controlled trial reported unfavorable effects of routine measurement of FFR, thereby questioning its validity in improving clinical outcomes. METHODS: MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were queried from January, 2000 through December, 2016 and studies comparing FFR and ANGIO guided PCI were included. Clinical endpoints assessed during hospitalization and at follow-up (>9 months) included: myocardial infarction (MI), major adverse cardiovascular events (MACE), target lesion revascularization (TLR), and all-cause mortality. Additional endpoints included number of PCIs performed, procedure cost, procedure time, contrast volume, and fluoroscopy time. RESULTS: A total of 51,350 patients (age 65 years, 73% male) were included from 11 studies. The use of FFR was associated with significantly lower likelihood of MI during hospitalization (OR 0.54, 95% CI: 0.39 to 0.75, P = 0.0003) and at follow-up (OR 0.53, 95% CI: 0.40 to 0.70, P = 0.00001). Similarly, FFR-PCI was associated with lower in-hospital MACE (OR 0.51, 95% CI: 0.37 to 0.70, P = 0.0001) and follow-up MACE (OR 0.63, 95% CI: 0.47 to 0.86, P = 0.004). In-hospital TLR was lower in the FFR-PCI group (OR 0.62, 95% CI: 0.40 to 0.97, P = 0.04), but not at follow-up (OR 0.83, 95% CI: 0.50 to 1.37, P = 0.46). There was no difference of in-hospital (OR 0.58, 95% CI: 0.31 to 1.09, P = 0.09) or follow-up all-cause mortality (OR 0.84, 95%CI: 0.59 to 1.20, P = 0.34). FFR-PCI was associated with significantly less PCI (OR 0.04, 95% CI: 0.01 to 0.15, P = 0.00001) with lower procedure cost (Mean Difference -4.27, 95% CI: -6.61 to -1.92, P = 0.0004). However, no difference in procedure time (Mean Difference 0.79, 95% CI: -2.41 to 3.99, P = 0.63), contrast use (Mean Difference -8.28, 95% CI: -24.25 to 7.68, P = 0.31) or fluoroscopy time (Mean Difference 0.38, 95% CI: -2.54 to 3.31, P = 0.80) was observed. CONCLUSIONS: FFR-PCI as compared to ANGIO-PCI is associated with lower in-hospital and follow-up MI and MACE rates. Although, in-hospital TLR was lower in the FFR-PCI group, this benefit was not present after 9 months. FFR-PCI group was also associated with less PCI and lower procedure costs with no effect on procedure time, contrast volume or fluoroscopy time.

Percutaneous angioplasty versus atherectomy for treatment of symptomatic infra-popliteal arterial disease.

BACKGROUND: Outcomes for debulking by atherectomy (ATH) for adjunctive treatment of below the knee (BTK) symptomatic arterial disease compared to percutaneous transluminal angioplasty alone (PTA) are unclear. METHODS: MEDLINE, EMBASE, PubMed and the Cochrane Central Register of Controlled Trials were queried from between 2000 and 2017 including studies comparing PTA alone to PTA-ATH. Random effect meta-analysis model was used to pool the data across the studies. Study endpoints included: vessel dissection, residual stenosis (<30%), mortality at 12months and amputation rates at 1 and 12months. RESULTS: A total of 2587 patients (72.9years; 63% male) were included from 4 studies (2 prospective, one of which was randomized, and 2 retrospective) comparing PTA alone to ATH-PTA in patients with symptomatic infra-popliteal disease. There was no significant difference between the two approaches in terms of vessel dissection [OR 3.73 with 95% CI 0.83 to 16.64, p=0.08] or residual stenosis [OR 0.41 with 95% CI 0.11 to 1.60, p=0.18]. Clinical outcomes did not differ in terms of 12month mortality [OR 3.47 with 95% CI 0.15 to 81.37, p=0.44], or limb amputation at 1month [OR 1.23 with 95% CI 0.91 to 1.67, p=0.18] or 12months [OR: 1.02 with 95% CI 0.83 to 1.26, p=0.83]. CONCLUSION: In patients undergoing (BTK) intervention, PTA alone and ATH-PTA was associated with similar outcomes in terms of vessel dissection and residual stenosis, mortality at 12months, and limb amputation at 1 or 12months.

Contemporary Arterial Access in the Cardiac Catheterization Laboratory.

Obtaining femoral and radial arterial access in the cardiac catheterization laboratory using state-of-the-art techniques is essential to optimize outcomes, patient satisfaction, and procedural efficiency. Although transradial access is increasingly used for coronary angiography and percutaneous coronary intervention, femoral access remains necessary for numerous procedures, many requiring large-bore access, including complex high-risk coronary interventions, structural procedures, and procedures involving mechanical circulatory support. For femoral access, contemporary access techniques should combine the use of fluoroscopy, ultrasound, micropuncture needle, femoral angiography, and vascular closure devices, when feasible. For radial access, ultrasound may reveal important anatomic features and expedite access. Despite randomized controlled trials supporting use of routine ultrasound guidance for femoral and/or radial arterial access, ultrasound remains underused in cardiac catheterization laboratories. This article reviews contemporary techniques to achieve optimal arterial access in the cardiac catheterization laboratory.

Endovascular versus surgical treatment for acute limb ischemia: a systematic review and meta-analysis of clinical trials.

BACKGROUND: A number of small studies have suggested that outcomes following endovascular (ENDO) therapy are comparable to those following surgical (SURG) revascularization for patients presenting with acute limb ischemia (ALI). We sought to compare mortality, limb amputation and recurrent ischemia across both revascularization strategies. METHODS: A comprehensive database search of MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL) electronic databases from January 1990 through January 2016 was performed to identify studies of ENDO versus SURG for ALI. Two independent reviewers selected studies and extracted the data. Random-effects meta-analysis was used to pool results across studies. Heterogeneity of treatment effect among trials was assessed using the I2 statistics. The primary endpoints were mortality and limb amputation at 1 month, 6 and 12 months. Secondary endpoint was recurrent ischemia at one year. RESULTS: A total of 1,773 patients were included from six studies (five randomized prospective and one observational retrospective) comparing ENDO and SURG in the setting of ALI. The mean age was 67 years and 65% of patients were male. There were no differences in mortality between the two groups at 1 month [risk ratio (RR) for ENDO vs. SURG is 0.70; 95% confidence interval (CI), 0.33 to 1.50], 6 months (RR 1.12; CI, 0.78 to 1.61) or 12 months (RR 0.74; CI, 0.29 to 1.85). Similarly, there was no significant difference in amputation rates between ENDO and SURG at 1 month (RR 0.75; CI, 0.40 to 1.42), 6 months (RR 0.87; CI, 0.52 to 1.48) or 12 months (RR 0.81; CI, 0.55 to 1.18). When looking into secondary outcomes, recurrent ischemia was not different between the two groups (RR 1.12; CI, 0.75 to 1.67). CONCLUSIONS: In patients presenting with ALI (<2 weeks of duration), ENDO and SURG approaches have similar rates of short-term and 12 month mortality, limb amputation and recurrent ischemia.

Comparison of Inferior Vena Cava Filters Placed at the Bedside via Intravenous Ultrasound Guidance Versus Fluoroscopic Guidance.

BACKGROUND: IVCFs are usually placed under fluoroscopic guidance in dedicated angiography suites. Bedside placement of inferior vena cava filters (IVCF) is possible in patients not suitable for transportation, but data regarding their use are limited. The objective of this study is to compare utilization, procedural outcomes, complications, and long-term patient outcomes associated with bedside placement of IVCFs using intravascular ultrasound (IVUS) and fluoroscopic placement of IVCF. METHODS: All patients receiving IVCF between January 2009 and December 2011 at a tertiary care institution were retrospectively identified. Data regarding patient characteristics, IVCF indications, complications, and outcomes were collected, and comparisons were made between patients receiving fluoroscopic-guided and IVUS-guided bedside IVCF. RESULTS: There were 117 bedside and 571 fluoroscopic-guided IVCF placed during this period. Patients receiving bedside IVCF were younger (50.8 vs. 60.7 years, P < 0.001), less often had malignancy (22.2% vs. 42.6%, P < 0.001), and received prophylactic filters more commonly (59.9% vs. 29.9%, P < 0.001). Placement-related complications occurred in 4.3% and 0.6%, respectively (bedside IVCF: 4 malpositions, 1 severe tilt; fluoroscopic-guided IVCF: 1 malposition, 1 severe tilt, P = 0.01). Indwelling IVCF-related complications occurred equally during median follow-up of 463 and 488 days, respectively (deep vein thrombosis: 13.7% vs. 13.3%, P = 0.92; pulmonary embolism: 5.1% vs. 4.0%, P = 0.61; filter thrombosis: 3.4% vs. 3.9%, P = 0.82). Time to indwelling complication was similar between groups (74 vs. 127 days, P = 0.29). CONCLUSIONS: Bedside placement of IVUS-guided IVCF is safe, but with higher procedural complications when compared with fluoroscopic placement. Long-term indwelling complications are similar between IVCF placed via bedside IVUS guidance and fluoroscopic approach.

Proximal balloon occlusion versus distal filter protection in carotid artery stenting: A meta-analysis and review of the literature.

INTRODUCTION: Carotid artery stenting (CAS) is typically performed using embolic protection devices (EPDs) as a means to reduce the risk of procedure-related stroke. In this study, we compared procedural morbidity and mortality associated with distal (D-EPD) vs. proximal (P-EPD) protection. METHODS: MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were queried from January 1998 through May 2015. Only studies comparing (D-EPD) and (P-EPD) were included. Two independent reviewers selected and appraised studies and extracted data in duplicate. Random-effects meta-analysis was used to pool outcomes across studies. Heterogeneity of treatment effect among studies was assessed using the I2 statistics. Publication bias was assessed using inspection of funnel plots. The primary endpoints included 30-day mortality and stroke. Secondary endpoints included new cerebral lesions on diffusion-weighted magnetic resonance imaging (DW-MRI) and contralateral lesions on DW-MRI. RESULTS: A total of 12,281 patients were included from 18 studies (13 prospective and 5 retrospective) comparing (D-EPD) and (P-EPD) in the setting of CAS. The mean patient age was 69 years and 64% of patients were male. No evidence of publication bias was detected. There was no significant difference between the two modalities in terms of the risk of stroke (risk difference [RD] 0.0, 95% confidence interval [CI] -0.01 to 0.01) or mortality (RD 0.0, 95% CI -0.01 to 0.01) nor was there any difference in the incidence of new cerebral lesions on DW-MRI or contralateral DW-MRI lesions. CONCLUSIONS: In patients undergoing CAS, both D-EPD and P-EPD provide similar levels of protection from peri-procedural stroke and 30 days mortality. © 2016 Wiley Periodicals, Inc.

Defining the common femoral artery: Insights from the femoral arterial access with ultrasound trial.

OBJECTIVE: We sought to establish the typical location of the common femoral artery (CFA) bifurcation, the origin and most inferior reflection of the inferior epigastric artery (IEA) relative to the femoral head (FH) and whether patient demographics predicted anatomical variations. BACKGROUND: In the absence of ultrasound guidance or prior imaging, the precise location of the CFA bifurcation and IEA can only be determined following access site angiography. Fluoroscopic landmarks are commonly used to estimate the location of the CFA bifurcation, but the position of the IEA is less well characterized. METHODS: Prospectively collected data on 989 patients with femoral angiography in the FAUST trial were analyzed. The level of CFA bifurcation and the origin and most inferior reflection of the IEA were classified by angiography. Logistic regression was used to explore whether baseline demographics were associated with anatomic variations. RESULTS: The CFA bifurcation occurs below the middle 1/3rd of the femoral head in 95% of patients, and no patient factors are predictive of a high bifurcation. The IEA origin has a more variable anatomically pattern, with high BSA, male gender, and white race associated with a low IEA origin. CONCLUSION: Operators should attempt to access the CFA at the level of the middle 1/3rd of the FH to maximize the chance of CFA cannulation. However, this location carries an 11% risk of being at or above the IEA origin. Baseline demographics were of limited utility for predicting anatomic variants of the CFA bifurcation and the course of the IEA. © 2016 Wiley Periodicals, Inc.