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.

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.

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.

Hemorrhagic and ischemic outcomes of Heparin vs. Bivalirudin in carotid artery stenting: A meta-analysis of studies.

INTRODUCTION: Bivalirudin, has been shown to have comparable efficacy and better safety profile when compared to unfractionated heparin (UFH) in percutaneous coronary interventions. Bivalirudin's safety in carotid artery stenting (CAS) was associated with better outcomes than heparin in some studies. In this Meta analysis we examine the hemorrhagic and ischemic outcomes associated with Bivalirudin compared to UFH during CAS. METHODS: A comprehensive literature search was conducted with the electronic databases MEDLINE, EMBASE, and CENTRAL. Random-effects meta-analysis method was used to pool risk ratio (RR) for both Heparin and Bivalirudin with 95% confidence interval (CI). Study outcomes included hemorrhagic complications; major/minor bleeding and intracranial hemorrhage (ICH) as well as ischemic complications including ischemic stroke, myocardial infarction, and 30 day mortality. RESULTS: A total of four studies were included enrolling 7,784 patients. Compared to UFH, Bivalirudin was associated with significantly lower major bleeding events with a relative risk (RR) of 0.53 (95% CI: 0.35-0.80; I2 = 0%). Minor bleeding events were significantly lower in the Bivalirudin group with a RR of 0.41 (95% CI: 0.2-0.82; I2 = 0%). Looking into other outcomes, there were no significant differences between anticoagulation strategies in terms of ischemic stroke (RR 0.8, with 95% CI: 0.60-1.06), intracranial hemorrhage (RR 0.73 with 95% CI: 0.27-1.98), myocardial infarction (RR 1.01 with 95% CI: 0.59-1.73) or 30 day mortality (RR 0.83 with 95% CI: 0.47-1.47). CONCLUSION: Compared to UFH, Bivalirudin is associated with lower bleeding risk when used during CAS. © 2016 Wiley Periodicals, Inc.

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.

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.

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

BACKGROUND: Variations in radiation dose between various X-ray systems have received limited study. OBJECTIVE: We examined the impact of X-ray system type on patient radiation dose during cardiac catheterization. METHODS: An anthropomorphic phantom was used in a series of standardized experiments that involved 15 sec of continuous cineangiography in 7 projections. Three to seven experiments were performed in four commonly used X-ray systems: Innova IGS (GE Healthcare), Integris Allura FD20 (Philips), Allura Clarity (Philips), and Artis one (Siemens). Phantom radiation dose was measured with a dedicated X-ray dosimetry system (Gafchromic radiology film and Film QA XR software, Ashland) that was precalibrated at 0, 1, 2, 3, and 4 Gray, and with the X-ray system built-in functions. RESULTS: Radiation dose was lowest with the Allura Clarity system [average film dose 4.2±0.1 cGray, peak film dose 18.3±1.6 cGray, Air Kerma (AK) dose 0.310±0.002 Gray, Dose Area Product (DAP) dose 23.72±0.84 Gray*cm2], intermediate with the Integris Allura FD20 (average film dose 4.4±1.1 cGray, peak film dose 29.4±15.5 cGray, AK 0.482±0.189 Gray, DAP 45.18±21.90 Gray*cm2), and highest with the Artis one system (average film dose 7.4±0.8 cGray, peak film dose 66.9±0.09 cGray, AK 0.746±0.085 Gray, DAP 75.93±9.11 Gray*cm2) and the Innova IGS system (average film dose 7.2±1.0 cGray, peak film dose 49.3±28.9 cGray, AK 0.874±0.340 Gray, DAP 92.28±14.73 Gray*cm2; P=0.011 for average film dose, P=0.019 for maximum film dose, P=0.033 for AK, and P=0.008 for DAP). CONCLUSIONS: The X-ray system type has significant impact on patient radiation dose during cardiac catheterization.

Plaque regression and progenitor cell mobilization with intensive lipid elimination regimen (PREMIER) trial design.

Progression of lipid rich necrotic core elements of atherosclerotic vulnerable plaque (VP) or its rupture leads to a majority of cardiovascular events. Endothelial progenitor cells (EPC) contribute to vascular healing and play a crucial role in repair following ischemic injury primarily by endothelialization of VP and neovascularization of ischemic myocardium. We present the rationale and design of the Plaque Regression and Progenitor Cell Mobilization with Intensive Lipid Elimination Regimen or the PREMIER Trial, which is designed to address the question for the very first time whether a highly intensive low-density lipoprotein (LDL)-lowering therapy with LDL-apheresis could lead to a more rapid and detectable reduction in coronary atheroma volume, along with a robust mobilization of EPC compared to standard statin therapy, in patients selected for percutaneous coronary intervention for an acute coronary syndrome.

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.

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.

Coronary slow flow--prevalence and clinical correlations.

BACKGROUND: Coronary slow flow phenomenon (CSFP) is defined as delayed coronary opacification in the absence of obstructive coronary artery disease. In the present study, we sought to define its prevalence and clinical features. METHODS AND RESULTS: The 1,741 consecutive patients who underwent coronary angiography (CAG) were identified. Those with normal left ventricular ejection fraction and normal coronary arteries were included in the study (n=158). TIMI frame counts were calculated, and data on demographics, comorbidities, and medication use were collected. CSFP was defined as frame count > 27. Multivariate logistic regression analysis was used to identify independent predictors of CSFP. CSFP was identified in 96 (5.5%) subjects referred for CAG. Subjects with CSFP were more obese (body mass index [BMI] 33.9 vs. 29.8 kg/m², P=0.003) and had lower high-density lipoprotein levels (39.7 vs. 45.7 mg/dl, P=0.04). In the CSFP group, total cholesterol, low-density lipoprotein and frame counts increased significantly with increasing vessel involvement (1-, vs. 2-, vs. 3-vessel involvement; P<0.05 for each variable). By multivariate analysis, male sex (odds ratio 3.36, 95% confidence interval 1.17-8.61, P=0.02) and higher BMI independently predicted the presence of CSFP (odds ratio 1.09, 95% confidence interval 1.03-1.15, P=0.003). CONCLUSIONS: CSFP is associated with male sex and obesity. Multivessel involvement may be a marker of more severe, diffuse disease. Further studies are needed to investigate this hypothesis.

Retrograde access via the popliteal artery to facilitate the re-entry technique for recalcitrant superficial femoral artery chronic total occlusions.

Subintimal recanalization is beneficial in selected patients with peripheral chronic total occlusions (CTO). However, in complex cases, re-entry into the true arterial lumen may prove to be unsuccessful with a conventional guidewire or a re-entry catheter when using standard femoral artery access. Our case series describes these technical dilemmas along with strategies that can be utilized to overcome these challenges.

Endovascular treatment of mesenteric ischemia.

OBJECTIVES: Our goal was to describe a single-center's experience in managing acute and chronic mesenteric ischemia with endovascular therapies. BACKGROUND: Open surgical revascularization has been considered the historical gold standard treatment for mesenteric ischemia though it poses considerable morbidity and mortality risk. An aging population with increased comorbidities makes endovascular treatment a more attractive treatment option. METHODS: Consecutive subjects receiving percutaneous mesenteric interventions for acute and chronic mesenteric ischemia from 2004 to 2010 were identified retrospectively. Information on comorbidities, symptoms, screening tests, procedural outcomes, and follow up was obtained. RESULTS: Thirty-one patients received percutaneous mesenteric interventions during this period. The mean age of the population was 65.0 years with roughly equal proportions of males (48.4%) and females (51.6%). Traditional cardiovascular risk factors were highly prevalent (hypertension 45.2%, diabetes 25.8%, dyslipidemia 38.7%, nicotine use 45.2%). Procedural success was 93.5%; no periprocedural complications were reported. During a mean follow up of 13 months, 16.1% required repeat revascularization and 22.6% died. Endovascular treatment of acute mesenteric ischemia was successful (n = 8) and no patient required open surgical revascularization acutely or during follow-up. CONCLUSIONS: Endovascular treatment of mesenteric ischemia is a safe and effective therapy with acceptable long-term results. Our experience with acute mesenteric ischemia suggests that percutaneous treatment may be an effective alternative to surgical revascularization in appropriately selected patients.

Isolated pharmacomechanical thrombectomy for the management of chronic DVT.

Thrombo-reduction in the setting of deep vein thrombosis (DVT) to prevent the postthrombotic syndrome has not been traditionally managed by interventional cardiologists. We report a case series of successful chronic DVT management with pharmacomechanical thrombectomy utilizing the Trellis device.

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.

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.

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.

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.