Featured Science for Interventional Cardiology From SCAI and EuroPCR 2019

Introduction
By George W. Vetrovec, MD, MACC
Editorial Team Lead, Invasive Cardiovascular Angiography & Interventions collection on ACC.org
Richmond, VA

The following is a summary of interesting and important featured science presented at the recent 2019 Congress of the European Association of Percutaneous Cardiovascular Intervention (EuroPCR.19) and 2019 Society for Cardiovascular Interventions and Angiography Scientific Sessions (SCAI.19), written by several experts in the field at my request. The studies range from additional data on radial and femoral access to novel potential treatment, from low-density lipoprotein (LDL) apheresis to acutely lower LDL in acute coronary syndromes (ACS) and change plaque biology and thus lower the risk of early recurrent events to an impedance device that potentially warns of early vascular bleeding. Exciting considerations! My thanks to the commentators for their brevity and focus on important results and their impact on future studies.

I would appreciate all feedback. The attempt is to provide a meaningful, quick catch-up on these meeting relative to topics of potential current or future impact on your interventional practice.

Cardiac Arrest and Death During Elective PCI
By Gregory J. Dehmer, MD, MACC
Cardiovascular Institute, Carilion Clinic, Virginia Tech Carilion School of Medicine
Roanoke, VA

At the recent EuroPCR.19, investigators from Belgium presented an analysis of registry data from 113,661 elective percutaneous coronary intervention (PCI) cases to define the occurrence of cardiac arrest and death in contemporary practice. Data were collected from 11 high-volume centers each performing approximately 1,500 cases annually and included patients with stable non-ST-segment elevation myocardial infarction (NSTEMI), unstable and stable angina, heart failure, or silent ischemia. Patients with ST-segment elevation myocardial infarction (STEMI), out-of-hospital cardiac arrest, pre-PCI inotropes, mechanical ventilation, or mechanical cardiac support were excluded. Approximately half of the total study cohort had a low SYNTAX score (≤20), a normal left ventricular ejection fraction (LVEF), or both. Cardiac arrest during PCI occurred in 330 patients (0.29%) with 162 (0.14%) dying in the catheterization laboratory or during the first 24 hours following the procedure. In simple terms, that is 1 cardiac arrest per 344 procedures resulting in 1 death per 702 procedures; roughly half of those suffering a cardiac arrest during the procedure die within the first 24 hours. Technical complications such as dissection, perforation, stroke, bleeding, or stent loss were felt to be the proximate cause of the cardiac arrest in 39% of patients followed by cumulative ischemia (32%), acute stent thrombosis (7%), no reflow (7%), and miscellaneous causes (13%). Technical complications occurred across the entire spectrum of PCI patients, but cumulative ischemia typically occurred in higher-risk patients with higher SYNTAX scores or lower LVEF who were undergoing more complex procedures. Mortality with salvage coronary bypass surgery or bail-out mechanical support was high. Although the authors collected data on LVEF and SYNTAX score, the mortality rate reported appears to be a raw mortality rate without risk adjustment.

It is tempting to compare this report with data collected in two large national registries, but this proved to be very difficult. The National Cardiovascular Data Registry (NCDR) does not collect information specific to the occurrence of cardiac arrest during PCI. Like the Belgian study, patients in the NCDR undergoing PCI for STEMI are tabulated separately from those undergoing PCI for indications other than STEMI. In this latter group, the risk-adjusted in-hospital mortality rate for the most recent rolling 4 quarters was 1.03%, considerably higher than the presumed unadjusted mortality rate of 0.14% in the Belgian study. Usually, unadjusted mortality rates are higher than risk-adjusted rates, making this difference even more striking. One possibility to explain this difference is that the mortality rate reported in the Belgian study is specific for those who suffer a cardiac arrest during the procedure and may not count other procedure-related mortalities not preceded by a cardiac arrest. For example, patients may suffer a fatal stroke related to the procedure but not suffer a cardiac arrest. Moreover, the NCDR tabulates mortalities up to the point of hospital discharge whereas the Belgian study ends at 24 hours after the procedure. Comparisons with the British Cardiovascular Interventional Society (BCIS) database provide some additional insights. BCIS data are reported for cardioversion during the procedure, but the type of rhythm disturbance necessitating the cardioversion is not reported. In-hospital death for elective stable patients was 0.17% and for patients with NSTEMI/unstable angina without shock was 0.70%.

Until details of the Belgian study are published, it will be difficult to fully integrate these findings into our overall understanding of PCI-procedure-related mortality. Nevertheless, data from the Belgian study provide a better understanding of the types of procedure-related complications that have the potential to cause cardiac arrest and the implications of cardiac arrest occurring during PCI.

LDL Apheresis Potentially a "Head Start" to Conventional Lipid-Lowering Methods Post-PCI in ACS
By Hector M. Garcia-Garcia MD, MSc, PhD
Georgetown University, MedStar CV Research Network
Washington, DC

I want to congratulate the authors on this well constructed and successful trial and make some comments. Banerjee et al. conducted a unique study in a few different ways:

  1. For the first time ever in the United States, the trial uses LDL apheresis for patients with ACS who are undergoing PCI.
  2. The trial has an uncommon intravascular ultrasound (IVUS) primary endpoint—total change in plaque volume—instead of more classical ones such as percent atheroma volume or normalized atheroma volume. The imaging length influences their chosen primary endpoint, and that is the reason why the others are more classical endpoints in IVUS study because they account for differences within and between groups in imaged length.
  3. The follow-up time of 90 days is also not the most common in IVUS studies. It is, nevertheless, interesting to see that there is a profound effect of LDL apheresis on reducing coronary plaque in such short time. On the other hand, it is somewhat surprising to see an increase in atheroma volume in the statin group. Most previous statin imaging trials (with longer follow-up times) have shown the opposite: a reduction.
  4. Finally, the peri-PCI adverse events (mostly hypotension and flushing) were higher in the LDL apheresis group.

In summary, this mechanistic trial is going to inform an outcome-based clinical trial that may address the high residual risk in patients with ACS.

National Cardiogenic Shock Initiative
By Cindy L. Grines MD, FACC, MSCAI
Northside Health System
Atlanta, GA

The National Cardiogenic Shock Initiative1 is a multicenter prospective registry in patients with acute myocardial infarction (MI) associated cardiogenic shock (CS) managed with Impella (Abiomed; Danvers, MA) mechanical circulatory support (MCS) and PCI. All 35 centers agreed to use a standardized protocol and measured in-hospital clinical outcomes, with inclusion criteria similar to the original SHOCK (One-Year Survival Following Early Revascularization for Cardiogenic Shock) trial,2 initiation of early MCS prior to PCI, and invasive hemodynamic monitoring.

Of the 171 patients enrolled, 78% presented with acute STEMI, shock was present on admission in 68%, 10% were undergoing cardiopulmonary resuscitation at the time of device insertion, and the Impella CP device was used in 92%. Using the standardized treatment protocol, in-hospital mortality was only 28% and was predicted by age >70, creatinine >2, lactate >4, and cardiac power output <0.6 Watts.

The authors are to be congratulated on the enormous amount of work to organize a national network of hospitals willing to collaborate on patients with CS. Determination of several strong predictors of mortality are extremely important. The standardized treatment protocol and early application of MCS is likely responsible for the favorable clinical outcomes. However, low mortality may be due in part to study design because the protocol excluded patients with prior intra-aortic balloon pump, unwitnessed cardiac arrest, anoxic encephalopathy, mechanical complications, and one patient with unspecified procedural complications. Therefore, it is difficult to compare these outcomes with other recent shock trials that had a higher proportion of patients with cardiac arrest.3-5 Despite the inability to accurately compare data, it is imperative to omit patients who will likely expire from anoxic encephalopathy in order to determine the benefits of hemodynamic support. Large, randomized trials will be ultimately be necessary to determine the best management of shock, but it is difficult to randomize given the rarity of CS in this era of early reperfusion and physician reluctance given public reporting of outcomes. In addition, it is nearly impossible to consent such sick patients. Thus, there should be a national imperative to allow post-hoc consenting (as in European shock studies) and incentivize physicians by exclusion of shock patients from public reporting of outcomes.

SURFs Up: Why Radial Makes More Sense Than Ever
By Richard R. Heuser, MD, FACC
St. Luke's Hospital and Medical Center
Phoenix, AZ

This excellent late-breaking trial by Nguyen et al. reemphasizes the importance and safety of the radial approach as opposed to the femoral approach for coronary intervention. This elegant prospective study randomized patients to the transfemoral as well as the transradial approach, and in both groups, ultrasound and standard technique were utilized. Looking at the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy Trial) data endpoints,6 they found that major endpoints, bleeding, major adverse cardiac events, and any vascular complications occurred in 1.3% of patients via the radial route and 3.5 % in the transfemoral, confirming previous trials comparing the wrist versus the groin. The ultrasound component was interesting in that the use appeared to increase the success rate of access but did not make an impact on the primary outcome. I think the two take-home messages were the following:

  1. The transradial approach is certainly safer and, in particular, significantly less harmful.
  2. The radial approach is particularly safer in patients with diabetes, obese patients, and female patients.

The imaging definitely helped operators but does not make a difference in terms of morbidity. I do not think the reader should conclude that operators should do radial procedure only on obese, diabetic female patients only. In fact, the radial approach should be the first choice in any coronary intervention by evidence-based medicine. In our center, we became a radial-first site 10 years ago, even before RIVAL (Radial Vs Femoral Access for Coronary Intervention)7 and the MATRIX (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX:)8 results were published. This excellent study confirms that other operators' particularly in the United States should consider this approach in all of their patients if at all possible.

ROBOT ACS
By Ion S. Jovin, MD, FACC
McGuire VAMC/Virginia Commonwealth University
Richmond, VA

The ROBOT-ACS (The Risk of Major Bleeding With Novel Anti-platelets: A Comparison of Ticagrelor With Clopidogrel in a Real World Population of 5000 Patients Treated for Acute Coronary Syndrome) trial, presented at EuroPCR.19, reported the results of a retrospective study using the United Kingdom Myocardial Infarction National Audit Programme database that compared the safety and efficacy of clopidogrel and ticagrelor in 5,116 consecutive patients treated for ACS in 5 hospitals in and around Liverpool before and after the approval of ticagrelor in the United Kingdom. The primary (safety) endpoint was major bleeding at 1 year, and the secondary endpoints were death and (repeat) MI at 1 year. The groups were relatively well balanced, but the patients who received clopidogrel were older and had more comorbidities and fewer revascularization procedures compared with the patients who received ticagrelor. Compared with the study population in the landmark PLATO (Platelet Inhibition and Patient Outcomes) study,9 the cohort in ROBOT-ACS was older, had lower incidences of STEMI and revascularization, and had a markedly higher mortality at 1 year (4.9% vs. 12.6%; p < 0.001). The main results showed no significant difference in the rate of bleeding in the main population but also no significant difference in mortality between the group treated with clopidogrel and the group treated with ticagrelor after adjustment for comorbidities. The rates of MI were not reported.

This is an interesting study primarily because it shows no difference in mortality between the group of patients with ACS treated with clopidogrel and the group of patients treated with ticagrelor. In the PLATO trial,9 the rate of death due to vascular causes as well as death due to any causes was reduced in the group treated with ticagrelor compared with the group treated with clopidogrel, and the rate of major bleeding was not significantly different between the groups. This led to a Class IIa indication in the guidelines to use ticagrelor preferentially over clopidogrel in patients undergoing an invasive strategy.10 The authors of the ROBOT-ACS study raise the possibility that the benefit of ticagrelor is perhaps not as pronounced in real-life clinical practice. However, in a study with a somewhat similar design comprising 45,067 patients with ACS done in Scandinavia11 and looking at similar endpoints, the risk of death was significantly lower with ticagrelor compared with clopidogrel (5.9% vs. 12.9% (adjusted hazard ratio 0.83 [0.75-0.92] at 24 months). The risk of major bleeding requiring readmission was slightly higher with ticagrelor compared with clopidogrel. Because these were also real-life patients, the findings in this study need to be reconciled with the findings in the ROBOT-ACS trial, but the differences are most likely due to difference in the populations studied and their management. Moreover, in a recent meta-analysis, Shah et al.12 also found that in patients with ACS, compared to clopidogrel, ticagrelor use was also associated with improved all-cause and cardiovascular mortality, although the evidence base was not large. The risk of major bleeding was not statistically higher with ticagrelor. In summary, in patients with ACS, the clinician is faced with choices regarding the antiplatelet agent and the duration of therapy (although the current guidelines still recommend 12 months dual antiplatelet therapy for ACS). By taking into account the patient's ischemic risk and the risk for bleeding as well as the relevant scientific evidence and by remembering the Milton Friedman adage that there is no such thing as a free lunch,13 the clinician will try to come up with the best available choice for the patient in front of him or her. Whether this is called clinical judgement or personalized medicine, the goal is the best possible outcome for the patient.

The AFR-PRELIEVE Trial
By D. Scott Lim, MD
UVA School of Medicine
Charlottesville, VA

Paitazoglou et al. presented the results from the early feasibility study, AFR-PRELIEVE (Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator in Heart Failure Patients), which investigated the implantation of the Occlutech Atrial Flow Regulator (Occlutech International AB; Helsingborg, Sweden) in both patients with preserved and reduced heart failure (heart failure with preserved ejection fraction and heart failure with reduced ejection fraction). The idea behind this device is that it would provide a pop-off for increased left atrial pressures and volume overload, to the higher compliance right side of the heart. The Occlutech Atrial Flow Regulator has limited radial force and therefore requires a static balloon atrial septostomy as part of the procedure.

This device was studied in an early feasibility study in 36 patients, with a mix of heart failure etiologies and a mix of device sizes (stratified based on patient hemodynamics) but with 100% implantation success and an excellent safety profile.

The AFR-PRELIEVE trial is of course limited by its non-randomized, non-controlled design, but its acute results help to validate the safety profile on inter-atrial shunt devices for which there are currently two larger randomized, controlled trials in progress.

First-in-Human Study of the Saranas Early Bird™ Bleed Monitoring System for the Detection of Endovascular Procedure-Related Bleeding Events
By Shadi Al Halabi, MD, MPH and Adhir Shroff, MD, MPH
University of Illinois – Chicago
Chicago, IL

The Early Bird™ Bleeding Monitoring System (Saranas, Inc.; Houston, TX) is a novel venous sheath with embedded sensors designed to detect bleeding by sensing a change in the vessel's bioimpedance. The goal is early detection of a bleeding event, during or after the procedure, allowing earlier corrective action. Investigators presented the first-in-human, observational study at SCAI.19, which enrolled 66 patients at 5 US sites who were undergoing endovascular procedures between August and December 2018. The primary endpoint was the level of agreement in bleeding detection between the Early Bird system and post-procedural computerized tomography (CT). The procedures included transcatheter aortic valve replacement (67%), PCI (13%), Impella (8%), and balloon aortic valvuloplasty (7%). There were 60 patients who underwent CT scans both before and after as part of the correlation cohort. The Early Bird sheaths are placed in the femoral vein and are either 6- or 8-Fr. The procedure access sheaths ranged from 6- to 24-Fr, with the majority being 14- and 16-Fr. The Early Bird detected bleeding in 39 (63%) of patients. Over half (20/39) of these bleeding events were considered Level 1 alerts and were associated with subclinical degrees of bleeding. Larger bleeds were detected by the system, but no retroperitoneal bleeds occurred in the study cohort. Bleeding events were more commonly detected after the procedure rather than during the procedure. No device-related complications were reported. The notifications led to increased surveillance, manual compression, crossover balloon placement, or a blood transfusion. The device's ability to detect bleeding showed a high level of agreement with CT imaging (Cohen's kappa of 0.84).

Vascular access site bleeding continues to be a major source of morbidity, mortality, and related costs associated with invasive cardiac procedures. The past decade has seen a number of innovations that have reduced these events, including conversion to radial access, use of smaller devices, pre-procedure imaging, and novel pharmacology. However, there is a direct relationship between sheath size and the risk of access site complications. The growing menu of percutaneous structural procedures and use of hemodynamic support devices presents an opportunity to develop novel strategies and therapies to reduce vascular complications. The Early Bird system, which the US Food and Drug Administration approved in May 2019, may provide an innovative solution to the burden of vascular access site bleeding. A more definitive study with relevant clinical outcomes and health economics data would be of significant value.

Defining a Common Lexicon in CS Care
By Behnam N. Tehrani, MD, FSCAI; Carolyn Marie Rosner, FNP; Alexander G. Truesdell, MD, FACC; Shashank S. Sinha, MD, MSc, FACC; Shashank S. Desai, MD, FACC; Wayne B. Batchelor, MD, FACC, FSCAI; Christopher M. O'Connor, MD, MACC
INOVA Heart and Vascular Institute
Falls Church, VA

At SCAI.19, a multidisciplinary working group of thought leaders from interventional cardiology, advanced heart failure, critical care, and nursing released a clinical consensus statement on the classification of cardiogenic shock (CS).14 In what has the potential to be a paradigm shift in the evaluation and management approach of this highly lethal and time-sensitive disease state, the authors proposed a five-stage classification schema designed to serve as a lingua franca for the wide array of CS states to facilitate more consistent identification and communication of disease severity, more standardized approaches to therapy, and a common framework for future research.

A brief description of the five stages of the proposed SCAI CS classification system follows:

  • Stage A. Patients "At Risk" for CS, typically those with large MIs or with acute decompensated failure. These patients have normal physical exam findings, normal biomarkers, and are normotensive with well-compensated hemodynamics (cardiac index ≥ 2.5 L/min/m2, CVP <10 mmHg, and pulmonary arterial saturation ≥65%).
  • Stage B. Patients in the "Beginning" stages of CS, with exam findings of volume overload, relative hypotension (systolic blood pressure <90 mmHg or mean arterial pressure <60 mmHg or a 30 mmHg drop from baseline blood pressure), and tachycardia. Lactate levels and hemodynamic parameters remain above the historical cut-off for CS (cardiac index ≥2.2 L/min/m2 and pulmonary arterial saturation ≥65%).
  • Stage C. Patients with "Classic" findings of CS, defined as clinical and biochemical evidence of hypoperfusion requiring pharmacologic and/or device-based interventions (e.g., vasoactive and inotropic agents and MCS therapies such as venoarterial extracorporeal membrane oxygenation). Hemodynamic findings include cardiac index <2.2 L/min/m2, pulmonary capillary wedge pressure >15 mmHg, right atrial/pulmonary capillary wedge pressure ratio ≥0.8, pulmonary arterial pulsatility index <1.85, and cardiac power output ≤0.6 Watts.
  • Stage D. Patients with Stage C disease who are clinically "Deteriorating" and not responding favorably to initial therapies. These patients often require further escalation of care, including additional vasopressors and/or MCS device support.
  • Stage E. Patients in "Extremis," defined as full circulatory collapse, often in the setting of cardiac arrest who require multiple life-sustaining interventions, including cardiopulmonary resuscitation or venoarterial extracorporeal membrane oxygenation. These patients also have marked biochemical derangements (pH ≤7.2, lactate ≥5).

The authors also propose an arrest modifier "A" to describe patients who have sustained a cardiac arrest, separate from their baseline A-E CS stages, given research findings suggesting increased risk for in-hospital mortality in patients with acute MI complicated by both cardiac arrest and CS.15

Since the pivotal SHOCK trial, in-hospital mortality rates in CS have remained persistently high for two decades.2,16 In the absence of adequately powered randomized controlled trial data enrolling comparable patient populations and utilizing standard shock severity definitions, widely disparate practice patterns have endured around the care of this very heterogeneous and hemodynamically complex syndrome.17 The SCAI authors should therefore be commended for taking important steps to develop a common language around CS care to address these important limitations.

Building on the established Interagency Registry for Mechanically Assisted Circulatory Support nomenclature system, which is widely known for its clinical stock phrases, the authors also ascribed three domains for each stage of CS. These include bedside physical exam findings, biochemical markers, and invasive hemodynamics, where there is increasing data suggesting that early utilization of the pulmonary arterial catheter can facilitate timely CS diagnosis and may also be associated with improved clinical outcomes.1,18-20 These parameters are unique as they are readily accessible, cross disciplinary, and actionable. They also provide clinicians a framework to more objectively risk stratify patients, including those with potentially irreversible hemometabolic shock, for whom MCS is unlikely to be beneficial.21 Potential opportunities for further investigation with this staging system include the following:

  1. Differentiation of CS due to acute MI and acute decompensated heart failure, which accounts for up to 30% of CS and comprises disease states with widely varying etiologies and pathophysiologies.22
  2. Elucidation of the unique clinical and hemodynamic features of the different phenotypes of CS (left ventricular, right ventricular, and biventricular shock), each of which has prognostically unique hemodynamic characteristics.23

Nevertheless, the development of a common lexicon around CS is a seminal achievement in acute cardiovascular care. It will hopefully facilitate clear and cogent communication among multidisciplinary clinician teams providing care for the CS patient and help expedite therapeutic pathways. The A-E classification system is also well-suited for retrospective review of past and current database and registry data. Knowledge gained from these analyses can then be used to identify meaningful patient- and device-specific factors that may importantly serve as the basis for future trial designs evaluating current and future care paradigms, such as hemodynamically tailored pharmacologic and device therapies, multidisciplinary shock teams, and regionalized "hub-and-spoke" models, to improve clinical outcomes associated with this highly morbid syndrome.1,19,24-26

The PRESSUREwire Trial
By George W. Vetrovec, MD, MACC
Editorial Team Lead, Invasive Cardiovascular Angiography & Interventions collection on ACC.org
Richmond, VA

Results of the PRESSUREwire (Practical Evaluation of Fractional Flow Reserve and Its Associated Alternate Indices During Routine Clinical Procedures) trial were presented at SCAI.19 by Erick Schampaert, MD, primary investigator, from Hospital Sacre-Coeur De Montreal in Montreal, Canada. The PRESSUREwire study was a multinational (15 countries, 70 hospitals) prospective registry enrolling over 2,200 patients with stable and ACS clinical presentations between October 2016 and February 2018. A quarter of patients (26.9%) had multivessel disease, and over half of patients had a culprit left anterior descending artery lesion. What is unique about this trial is that operators recorded their treatment plans (medical therapy, PCI, or coronary artery bypass grafting [CABG]) after angiography but before fractional flow reserve (FFR) measurement. Application of FFR changed angiographic-based treatment plans in 34.9% of patients.

A breakdown of FFR-based therapeutic changes are as follows. Based on angiography, 61.5% of patients were considered candidates for medical management. After FFR evaluation, 19.1% of patients were reassigned to PCI, and 2.5% of patients were considered CABG candidates. More dramatic is the fact that of the 32.7% of patients destined for PCI after angiography, 51.6% were reassigned to medical therapy, and 2.7% became surgical candidates. Planned CABG procedures based on angiography comprised 5.4% of the original treatment plan; post-FFR, 30.3% of patients were treated medically, and 56.3% were changed to PCI. Overall, the numbers of patients receiving each therapy were relatively similar after adding FFR analysis, but there were significant individual patient plan changes.

A major limitation of this study is the lack of follow-up to determine if clinical outcomes were similar for patients with changed decisions based on FFR. One hopes so, and the authors have noted that late follow-up will be reported at future meetings.

FFR has assumed greater importance in assessing lesion severity and, therefore, need for revascularization based on the premise that treating only lesions shown to be hypodermically significant improves outcomes. Simply put, for PCI, stenting non-significant lesions is associated with less adverse events and better late outcomes,27,28 as was shown in FAME I and II (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) studies.

Thus, the PRESSUREwire trial challenges angiographic-only decisions, which seems reasonable given the background FFR data showing changes in management by this strategy. However, the final test will be the impact of late outcomes based on these modified decisions, which hopefully show no unexpected adverse outcomes to the treatment changes while, most importantly, demonstrating clinical benefit regarding angina management and a reduction in overall recurrent cardiovascular events.

References

  1. Basir MB, Kapur NK, Patel K, et. al. Improved Outcomes Associated with the use of Shock Protocols: Updates from the National Cardiogenic Shock Initiative. Catheter Cardiovasc Interv 2019;93:1173-83.
  2. Hochman JS, Sleeper LA, Webb JG, et al. Early revascularization in acute myocardial infarction complicated by cardiogenic shock. SHOCK Investigators. Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock. N Engl J Med 1999;341:625-34.
  3. Thiele H, Zeymer U, Neumann FJ, et. al. Intraaortic balloon support for myocardial infarction with cardiogenic shock. N Engl J Med 2012;367:1287-96.
  4. Ouweneel DM, Eriksen E, Sjauw KD, et. al. Percutaneous Mechanical Circulatory Support Versus Intra-Aortic Balloon Pump in Cardiogenic Shock After Acute Myocardial Infarction. J Am Coll Cardiol 2017;69:278-87.
  5. Thiele H, Akin I, Sandri M, et al. PCI Strategies in Patients with Acute Myocardial Infarction and Cardiogenic Shock. N Engl J Med 2017;377:2419-32.
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  7. Jolly SS, Yusuf S, Cairns J, et al. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet 2011;377:1409-20.
  8. Valgimigli M, Gagnor A, Calabró P, et al. Radial versus femoral access in patients with acute coronary syndromes undergoing invasive management: a randomised multicentre trial. Lancet 2015;385:2465-76.
  9. Wallentin L, Becker RC, Budaj A, et al. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med 2009;361:1045-57.
  10. Amsterdam EA, Wenger NK, Brindis RG, et al. 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation 2014;130:e344-426.
  11. Sahlén A, Varenhorst C, Lagerqvist B, et al. Outcomes in patients treated with ticagrelor or clopidogrel after acute myocardial infarction: experiences from SWEDEHEART registry. Eur Heart J 2016;37:3335-42.
  12. Shah R, Rashid A, Hwang I, Fan TM, Khouzam RN, Reed GL. Meta-Analysis of the Relative Efficacy and Safety of Oral P2Y12 Inhibitors in Patients With Acute Coronary Syndrome. Am J Cardiol 2017;119:1723-8.
  13. Kinnaird T. "No Such Thing as a Free Lunch": Personalized P2Y12 Inhibition to Optimize Patient Outcomes. J Am Heart Assoc 2019;8:e011660.
  14. Baran DA, Grines CL, Bailey S, et al. SCAI clinical expert consensus statement on the classification of cardiogenic shock: This document was endorsed by the American College of Cardiology (ACC), the American Heart Association (AHA), the Society of Critical Care Medicine (SCCM), and the Society of Thoracic Surgeons (STS) in April 2019. Catheter Cardiovasc Interv 2019;94:29-37.
  15. Tyler J, Henry J, Garberich R, et al. The impact of cardiac arrest and cardiogenic shock on outcomes in ST-elevation myocardial infarction. J Am Coll Cardiol 2019;73(Sup 1):167.
  16. van Diepen S, Katz JN, Albert NM, et al. Contemporary Management of Cardiogenic Shock: A Scientific Statement From the American Heart Association. Circulation 2017;136:e232-e268.
  17. Strom JB, Zhao Y, Shen C, et al. Hospital Variation in the Utilization of Short-Term Nondurable Mechanical Circulatory Support in Myocardial Infarction Complicated by Cardiogenic Shock. Circ Cardiovasc Interv 2019;12:e007270.
  18. Sotomi Y, Sato N, Kajimoto K, et al. Impact of pulmonary artery catheter on outcome in patients with acute heart failure syndromes with hypotension or receiving inotropes: from the ATTEND Registry. Int J Cardiol 2014;172:165-72.
  19. Tehrani BN, Truesdell AG, Sherwood MW, et al. Standardized Team-Based Care for Cardiogenic Shock. J Am Coll Cardiol 2019;73:1659-69.
  20. Hernandez GA, Lemor A, Blumer V, et al. Trends in Utilization and Outcomes of Pulmonary Artery Catheterization in Heart Failure With and Without Cardiogenic Shock. J Card Fail 2019;25:364-71.
  21. Esposito M, Bader Y, Pedicini R, Breton C, Mullin A, Kapur NK. The role of acute circulatory support in ST-segment elevation myocardial infarction complicated by cardiogenic shock. Indian Heart J 2017;69:668-74.
  22. Tehrani BN, Rosner CM, Sinha SS. Not All Shock Is Created Equal: Developing a Standardized Treatment Approach for Cardiogenic Shock. JACC Heart Fail 2019;7:477-80.
  23. Cooper LB, Mentz RJ, Stevens SR, et al. Hemodynamic Predictors of Heart Failure Morbidity and Mortality: Fluid or Flow? J Card Fail 2016;22:182-9.
  24. Rab T. "Shock Teams" and "Shock Docs". J Am Coll Cardiol 2019;73:1670-2.
  25. Rab T, Ratanapo S, Kern KB, et al. Cardiac Shock Care Centers: JACC Review Topic of the Week. J Am Coll Cardiol 2018;72:1972-80.
  26. Kapur NK, Alkhouli MA, DeMartini TJ, et al. Unloading the Left Ventricle Before Reperfusion in Patients With Anterior ST-Segment-Elevation Myocardial Infarction. Circulation 2019;139:337-46.
  27. Tonino PA, De Bruyne B, Pijls NH, et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med 2009;360:213-24.
  28. Xaplanteris P, Fournier S, Pijls NHJ, et al. Five-Year Outcomes with PCI Guided by Fractional Flow Reserve. N Engl J Med 2018;379:250-9.

Keywords: Acute Coronary Syndrome, Adenosine, Angina, Unstable, Angina, Stable, Atrial Fibrillation, Atrial Pressure, Blood Platelets, Cardiopulmonary Resuscitation, Catheterization, Clinical Protocols, Blood Component Removal, Cohort Studies, Electric Countershock, Creatinine, Comorbidity, Blood Transfusion, Endovascular Procedures, Diabetes Mellitus, Diabetes Mellitus, Femoral Vein, Evidence-Based Medicine, Follow-Up Studies, Feasibility Studies, Groin, Goals, Heart Arrest, Heart Atria, Heart Failure, Hemorrhage, Hemodynamics, Hospital Mortality, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Hypotension, Hypoxia, Brain, Informed Consent, Obesity, Myocardial Infarction, Lipids, Out-of-Hospital Cardiac Arrest, Lactates, Percutaneous Coronary Intervention, Patient Readmission, Pilot Projects, Plaque, Atherosclerotic, Platelet Aggregation Inhibitors, Prospective Studies, Research Personnel, Registries, Respiration, Artificial, Retrospective Studies, Risk Adjustment, Shock, Cardiogenic, Robotics, Stents, Stroke, Stroke Volume, Thrombosis, Ticlopidine, Tomography, Tomography, X-Ray Computed, Transcatheter Aortic Valve Replacement, Triage, United States Food and Drug Administration, Coronary Angiography


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