SCAI Manual of Standard Operating Procedures for Performing Scientific Surveys.

The Society for Cardiovascular Angiography & Interventions (SCAI) endeavors to serve the interventional cardiology community, including both clinicians and patients. The SCAI Scientific Oversight Committee is charged with annually reviewing the scientific needs of the membership at large, including survey-based research of the practice patterns and perspectives of SCAI members and stakeholders. This document is intended as a reference by the survey proponents, document writing groups, external collaborators, SCAI representatives, peer reviewers, and anyone seeking information about the SCAI surveys program. The aims of this SCAI document are to: (1) provide a framework for members to develop survey requests that are relevant, feasible, and align with the Society's missions and goals; (2) promote transparency and clarity for the process of performing a survey through SCAI; (3) establish the criteria for evaluating survey requests and provide input on reliable and meaningful design, data collection, and best practices; and (4) facilitate collaboration and communication between the survey committee and members of SCAI to maximize the impact of the findings to the interventional community at large.

Patterns of Care and Outcomes of Ambulatory Endovascular Interventions in Lower Extremity Peripheral Arterial Disease.

Lower extremity endovascular intervention (LE-EVI) is gaining popularity as the primary treatment modality for patients with symptomatic peripheral artery disease refractory to noninvasive management. We examined the contemporary patterns of care, regional variation, and outcomes of ambulatory LE-EVI in the United States. The National Ambulatory Surgery Sample was analyzed to identify 266,563 records with peripheral artery disease and LE-EVI between January 1, 2016 and December 31, 2017. The mean age of the study cohort was 68.9 years and 40.5% were women. The majority of the endovascular interventions were performed at large (58.1%), urban teaching (64.1%), private not-for-profit (76.8%) centers, and the southern region accounted for most cases (43%). Periprocedural major adverse renal and cardiovascular events and other complications were 0.5% and 3.3%, respectively. Most patients (97.6%) were discharged home after the procedure. Age, female gender, uncontrolled hypertension, ischemic heart disease, heart failure, arrhythmia, chronic kidney disease, malnutrition, non-Medicare insurance, private for-profit, urban teaching facilities, and southern and midwest regions were associated with higher odds of major adverse renal and cardiovascular events. The mean charges per patient encounter were $56,500, with significant differences across various patient and facility characteristics. In conclusion, our study demonstrates the use, patterns of care, financial aspect, and overall safety of ambulatory LE-EVIs in a real-world setting.

Best Practices for Cardiac Catheterization Laboratory Morbidity and Mortality Conferences.

Cardiac catheterization laboratory (CCL) morbidity and mortality conferences (MMCs) are a critical component of CCL quality improvement programs and are important for the education of cardiology trainees and the lifelong learning of CCL physicians and team members. Despite their fundamental role in the functioning of the CCL, no consensus exists on how CCL MMCs should identify and select cases for review, how they should be conducted, and how results should be used to improve CCL quality. In addition, medicolegal ramifications of CCL MMCs are not well understood. This document from the American College of Cardiology's Interventional Section attempts to clarify current issues and options in the conduct of CCL MMCs and to recommend best practices for their conduct.

Strategies for Reducing Vascular and Bleeding Risk for Percutaneous Left Ventricular Assist Device-supported High-risk Percutaneous Coronary Intervention.

In patients at high risk for haemodynamic instability during percutaneous coronary intervention (PCI), practitioners are increasingly opting for prophylactic mechanical circulatory support, such as the Impella® heart pump (Abiomed, Danvers, MA, USA). Though Impella-supported high-risk PCI (HRPCI) ensures haemodynamic stability during the PCI procedure, access-related complication rates have varied significantly in published studies. Reported variability in complication rates relates to many factors, including anticoagulation practices, access and closure strategy, post-procedure care and variations in event definitions. This article aims to outline optimal strategies to minimize vascular and bleeding complications during Impella-supported HRPCI based on previously identified clinical, procedural and postprocedural risk factors. Practices to reduce complications include femoral skills training, standardized protocols to optimize access, closure, anticoagulation management and post-procedural care, as well as the application of techniques and technological advances. Protocols integrating these strategies to mitigate access-related bleeding and vascular complications for Impella-supported procedures can markedly limit vascular access risk as a barrier to appropriate large-bore mechanical circulatory support use in HRPCI.

Cost savings for pVAD compared to ECMO in the management of acute myocardial infarction complicated by cardiogenic shock: An episode-of-care analysis.

BACKGROUND: Acute myocardial infarction complicated by cardiogenic shock (AMICS) occurs in up to 10% of acute myocardial infarction admissions and is associated with high mortality, frequent adverse outcomes, prolonged hospitalizations, extensive medical resource utilization, and major cost. Using hospital cost data for Medicare Fee-for-Service (FFS) patients with AMICS, we sought to evaluate in hospital and 45-day outcomes and cost, comparing patients treated with percutaneous ventricular assist device (pVAD) versus extracorporeal membrane oxygenation (ECMO). The goal of this study was to better understand clinical and economic outcomes of AMICS to help clinicians and hospitals optimize outcomes most economically for AMICS patients. METHODS: A retrospective claims analysis identified patients from the full census Medicare Standard Analytic Files compiled by the Center for Medicare and Medicaid (CMS) including: Inpatient, Outpatient, Skilled Nursing Facility and Home Health files for Medicare FFS beneficiaries. Study costs were defined as the total costs incurred by providers for treating a population with AMICS. Medicare FFS beneficiaries who experienced an inpatient admission during the index period (January 1, 2015 to March 31, 2017) with a diagnosis of AMICS were eligible for study inclusion and were identified by the presence of appropriate International Classification of Diseases, Ninth and Tenth Versions (ICD-9 and ICD-10) diagnosis and procedure codes. To create a matched sample and control for any baseline differences, a 1:1 Propensity Score Matching (PSM) was performed based on criteria such as age, gender, race, geographic distribution, and 11 high-cost comorbidities (e.g., congestive HF, coronary artery disease, diabetes, etc.). Index length of stay (LOS), index costs, discharge disposition (including mortality), post-index utilization, and episode-of-care (EOC) costs were reviewed. EOC was defined as index admission for all patients plus a 45-day post index period for patients who survived the index admission. RESULTS: Each cohort included 338 patients. Index in-hospital mortality rates were 53% for pVAD versus 64% for ECMO (178 vs. 217; p = .0023), and total EOC in-hospital mortality rates were 66% for pVAD versus 74% for ECMO (222 vs. 250; p = .0160). Index LOS for pVAD was 27% lower versus ECMO (12.12 vs. 16.59; p = .0006). The index LOS for patients discharged alive was 25% lower for pVAD versus ECMO (17.73 vs. 23.62; p = .0016). For patients that experienced in-hospital mortality during their index stay, pVAD had a 44% lower LOS compared to ECMO (7.08 vs. 12.66; p < .0001). Following index hospitalization, the average cost savings with additional inpatient care was 31% lower for pVAD patients ($62,188 vs. $90,087; p = NS). During the EOC, pVAD patients incurred 32% lower costs compared to ECMO patients ($117,849 vs. $172,420; <.0001). CONCLUSIONS: This study of Medicare FFS patients demonstrates that hospitals utilizing pVAD for appropriately selected AMICS patients have reduced mortality rates and reduced index LOS with lower index facility costs and lower post index 45-day costs. The study results offer hospitals and clinicians an opportunity to improve clinical outcomes and reduce total EOC costs in treating patients with AMI complicated by CS.

A Review of Bleeding Risk with Impella-supported High-risk Percutaneous Coronary Intervention.

Complex, high-risk percutaneous coronary intervention (HR-PCI) is increasingly being performed, often with mechanical circulatory support (MCS), though to date, there are limited randomised data on the efficacy of MCS for HR-PCI. The majority of MCS is provided by intra-aortic balloon pumps, but increasingly Impella® (Abiomed, Danvers, MA, USA) heart pumps are being used. While the Impella pumps provide greater increases in cardiac output, these devices require large bore access, which has been associated with an increased risk of bleeding and vascular complications. Decisions regarding the use of Impella are often based on risk-benefit considerations, with Impella-related bleeding risk being a major factor that can impact decisions for planned use. While bleeding risk related to large bore access is a concern, published data on the risk have been quite variable. Thus, the goal of this article is to provide a comprehensive review of reports describing bleeding and vascular complications for Impella-supported HR-PCI.

Comparison of In-Hospital Outcomes in Patients Having Limb-Revascularization With Versus Without Atrial Fibrillation.

The impact of atrial fibrillation (AF) on clinical outcomes among patients with peripheral artery disease (PAD) who undergo limb revascularization procedures is not well understood. We aim to compare in-hospital outcomes for patients with and without AF who underwent limb revascularization. We identified patients with PAD aged ≥18 years that underwent limb revascularization using endovascular or surgical approaches in the National Inpatient Sample between 2002 and 2014. Multivariate logistic regression analysis was performed to examine in-hospital outcomes. A total of 2,283,568 patients underwent limb revascularization during the study duration and 294,469 (12.9%) had AF. Patients with AF were older (mean age 76.1 ± 10.0 years), more likely to be women and white, compared with non-AF group. Among patients who had surgical revascularization, AF was associated with a higher rates of in-hospital mortality (6.4% vs 2.5%, adjusted odds ratio [aOR]: 1.09 [95% confidence interval {CI}: 1.05 to 1.12]) and major amputation (5.2% vs 3.8%, aOR: 1.05 [95% CI: 1.02 to 1.08]), compared with non-AF group. Among patients who had endovascular intervention (EVI), AF was associated with a higher rates of in-hospital mortality (3.8% vs 1.6%, aOR: 1.29 [95% CI: 1.24 to 1.33]) and major amputation (5.2% vs 3.9%, aOR: 1.07 [95% CI: 1.04 to 1.10]), compared with non-AF group. Within study period, EVI utilization increased in patients with and without AF (Ptrend <0.001); whereas, surgical revascularization utilization decreased in patients with and without AF (Ptrend <0.001). In conclusion, among patients with PAD who undergo limb revascularization, AF appears to be associated with poor in-hospital outcomes.

Expanding opportunities for stent optimization.

Restenosis is reduced but continues to impact optimal late PCI outcomes. FFR post stenting can predict late need for repeat revascularization. Intraluminal Intensity of Blood Speckle measured via Intravascular Ultrasound may provide another method to predict target vessel revascularization.

Stent "Hygiene".

Studies demonstrate ideal Stent expansion with prolonged inflations. Longer inflations, a mediator of greater stent expansion, lower immediate, subacute, and late stent failure. Research should focus on components of stent deployment that optimize early and late stent outcomes.

Rationale and design of the Virginia Commonwealth University-Anakinra Remodeling Trial-3 (VCU-ART3): A randomized, placebo-controlled, double-blinded, multicenter study.

There is clear association between the intensity of the acute inflammatory response during acute myocardial infarction (AMI) and adverse prognosis after AMI. Interleukin-1 (IL-1) is a pro-inflammatory cytokine released during AMI and involved in adverse remodeling and heart failure (HF). We describe a study to evaluate the safety and efficacy of IL-1 blockade using an IL-1 receptor antagonist (anakinra) during the acute phase of ST-segment elevation myocardial infarction (STEMI). The Virginia Commonwealth University-Anakinra Remodeling Trial-3 (VCU-ART3; http://www.ClinicalTrials.gov NCT01950299) is a phase 2, multicenter, double-blinded, randomized, placebo-controlled clinical trial comparing anakinra 100 mg once or twice daily vs matching placebo (1:1:1) for 14 days in 99 patients with STEMI. Patients who present to the hospital with STEMI within 12 hours of symptom onset will be eligible for enrollment. Patients will be excluded for a history of HF (functional class III-IV), severe valvular disease, severe kidney disease (stage 4-5), active infection, recent use of immunosuppressive drugs, active malignancy, or chronic autoimmune/auto-inflammatory diseases. We will measure the difference in the area under the curve for C-reactive protein between admission and day 14, separately comparing each of the anakinra groups with the placebo group. The P value will be considered significant if <0.025 to adjust for multiple comparisons. Patients will also be followed for up to 12 months from enrollment to evaluate cardiac remodeling (echocardiography), cardiac function (echocardiography), and major adverse cardiovascular outcomes (cardiovascular death, MI, revascularization, and new onset of HF).