Standardized Definitions for Cardiogenic Shock Research and Mechanical Circulatory Support Devices: Scientific Expert Panel From the Shock Academic Research Consortium (SHARC).

The Shock Academic Research Consortium is a multi-stakeholder group, including representatives from the US Food and Drug Administration and other government agencies, industry, and payers, convened to develop pragmatic consensus definitions useful for the evaluation of clinical trials enrolling patients with cardiogenic shock, including trials evaluating mechanical circulatory support devices. Several in-person and virtual meetings were convened between 2020 and 2022 to discuss the need for developing the standardized definitions required for evaluation of mechanical circulatory support devices in clinical trials for cardiogenic shock patients. The expert panel identified key concepts and topics by performing literature reviews, including previous clinical trials, while recognizing current challenges and the need to advance evidence-based practice and statistical analysis to support future clinical trials. For each category, a lead (primary) author was assigned to perform a literature search and draft a proposed definition, which was presented to the subgroup. These definitions were further modified after feedback from the expert panel meetings until a consensus was reached. This manuscript summarizes the expert panel recommendations focused on outcome definitions, including efficacy and safety.

A "fully upper extremity" bailout of direct transaxillary large bore arterial access: A refinement within arm's reach?

Contemporary direct ("fully percutaneous") transaxillary (TAx) large-bore arterial access technique advocates for a 0.018" wire to be passed from femoral arterial access to axillary artery to serve percutaneous bailout options. However, in certain patients, avoiding femoral arterial access entirely may be desired. We describe the merits of a "fully upper extremity" (FUE) bailout approach, as a refinement to previously described direct TAx technique.

Limb dysfunction after transradial access: A search for an understanding.

Limb dysfunction is common after radial access although many show dysfunction at baseline. Thrombosis may be present in the radial artery but is not necessary to manifest limb dysfunction. The role of periarterial nerve damage to this syndrome remains uncertain.

Distal (dorsal) radial access: Approaching acceptability for a backdoor approach to the arterial system.

Published data on distal radial access has increased since its introduction via the Internet several years ago. Based on reports of over 4,000 procedures the success with the distal radial approach appears to be similar to that of tradition radial when good pulses are available. The distal radial approach may have advantages with preservation of radial artery function after catheterization.

Gastrointestinal bleeding after percutaneous coronary intervention: Not just a short-term complication but a long-term marker of mortality risk.

The incidence of gastrointestinal (GI) bleeding after percutaneous coronary interventional has remained stable recently although those undergoing treatment for ST-elevation myocardial infarction appear to be doing better. Short-term prognosis is worsened after a GI bleed and this adverse outcome persists out to at least 1 year. Poor outcomes late after a GI bleed suggest persistence patient factors that require further study to understand who is at risk, whether short-term measures can prevent bleeding, and whether interventions after bleeding can improve long-term outcomes.

A look into stent-related thrombus-burden: Bivalirudin versus heparin.

Use of optical coherence tomography (OCT) adds an assessment of thrombus burden remaining on stents after PCI for acute coronary syndromes. Potential variations in stent-related thrombus burden can be documented by OCT as a function of peri-procedural pharmacology supporting the use of OCT in future hypothesis testing. Bivalirudin remains a reliable and expensive alternative to heparin in cases of HIT or patients at high bleeding risk during transfemoral PCI.

SCAI expert consensus statement update on best practices for transradial angiography and intervention.

Transradial angiography and intervention continues to become increasingly common as an access site for coronary procedures. Since the first "Best Practices" paper in 2013, ongoing trials have shed further light onto the safest and most efficient methods to perform these procedures. Specifically, this document comments on the use of ultrasound to facilitate radial access, the role of ulnar artery access, the utility of non-invasive testing of collateral flow, strategies to prevent radial artery occlusion, radial access for primary PCI and topics that require further study.

Radial versus femoral approach for saphenous vein grafts angiography and interventions.

BACKGROUND: Coronary angiography and intervention to saphenous venous grafts (SVGs) remain challenging. This study aimed to investigate the feasibility and safety of the radial approach compared to femoral access in a large cohort of patients undergoing SVG angiography and intervention. METHODS: Data from 1,481 patients from Canada, United States, and Spain who underwent procedures between 2010 and 2016 were collected. Patients must have undergone SVG coronary angiography and/or intervention. Demographics, procedural data, and in-hospital complications were recorded. RESULTS: Procedures were undertaken by either the radial (n = 863, 211 intervention) or femoral (n = 618, 260 intervention) approach. The mean number of SVGs per patient was similar between groups (radial 2.3 ± 0.7 vs femoral 2.6 ± 1.1, P = .61), but the radial group required a fewer number of catheters (2.6 ± 1.7 vs 4.1 ± 1.1, P < .001). Fluoroscopy time was comparable between groups, and there was a trend toward lower contrast volume in the radial group (P = .045). Overall, the total dose of heparin was significantly higher in the radial group (P < .001); however, radial patients experienced significantly less access-site bleeding complications (P < .001). Outpatients undergoing radial SVG interventions had a higher likelihood of a same-day discharge home (P < .001). CONCLUSIONS: Radial access for SVG angiography and intervention is safe and feasible, without increasing fluoroscopy time. In experienced centers, radial access was associated with fewer catheters used, lower contrast volume, and lower rate of vascular access-site bleeding complications. Moreover, outpatients undergoing SVG percutaneous coronary intervention though the radial approach had a higher likelihood of a same-day discharge home.

Opportunities for enhancing the care of older patients with ST-elevation myocardial infarction presenting for primary percutaneous coronary intervention: Rationale and design of the SAFE-STEMI for Seniors trial.

Advanced age is directly related to worse outcomes following ST-elevation myocardial infarction (STEMI) and higher complication rates from antithrombotic therapies and primary percutaneous coronary intervention (PCI). Often excluded from clinical trials, seniors presenting with STEMI remain an understudied population despite contributing to 140,000 hospital admissions annually. The SAFE-STEMI for Seniors study is a prospective, multicenter, unblinded, randomized clinical trial designed to examine the efficacy and safety of instantaneous wave-free ratio-guided complete revascularization in multivessel disease, while also investigating other components of STEMI care for patients ≥60 years including the efficacy and safety of zotarolimus-eluting stents for primary PCI and transradial PCI with the Glidesheath Slender and TR band. The SAFE-STEMI trial represents North America's first and only prospective randomized investigational device exemption study to use a Coordinated Registry Network infrastructure with collaborative partnering across industry manufacturers, promoting both efficiency and reduced cost of evidence development for regulatory decisions related to both diagnostic and therapeutic technologies in a single study design. The study has been powered to evaluate 2 independent co-primary end points in a population of older patients with STEMI: (1) third-generation drug-eluting stents for primary PCI and (2) instantaneous wave-free ratio-guided complete revascularization versus infarct-related artery-only revascularization.

Heparin, bivalirudin, or the best of both for STEMI interventions.

Whether heparin, bivalirudin, or bivalirudin delivered on the background of prior heparin therapy, during primary PCI therapy is associated with a better outcome is difficult to ascertain from any one study. Meta-analysis of available trials suggests that the use of bivalirudin on top of prior heparin therapy may be associated with the lowest all-cause mortality and major adverse cardiovascular events while preserving much of the access site bleeding reduction of bivalirudin alone. There may be a role for initial therapy of STEMI with a broad-spectrum anticoagulant such as heparin that is then focused to a more specific direct-thrombin inhibitor (bivalirudin) in primary PCI.

A catheter-based bariatric procedure: Wishful thinking or an intriguing concept.

Left gastric artery embolization acutely lowers ghrelin levels and is associated with modest weight loss sustainable for 1 year in morbidly obese patients. The procedure is relative quick, free of access complications when done via the radial artery, but long-term sequelae and the durability of ischemic injury to the fundus of the stomach is uncertain. Present reports provide pilot and proof-of-concept data that should fashion further study, but application to routine practice today is premature.

Treating hemolysis due to perivalvular leaks: It is all about modifying micro-jets and not the volume of regurgitation.

Paravalvular leak closure may have a therapeutic effect on the extent of hemolysis that some patients experience after valve surgery. Reduction of hemolysis is most likely in a patient with a mechanical valve and is not necessarily correlated with the volume of regurgitative flow or its subsequent reduction. Hemolysis associated with biological valves are less likely to respond to perivalvular leak closure suggesting that mechanisms other than net volume of regurgitation or micro-jets are present and should be considered.

Roadmap for the radial: Should we stop for directions?

Regimented use of radial artery angiography prior to ST-segment myocardial infarction (STEMI) intervention may improve complication rates and can be associated with improved procedural success, procedural time, and reduction in access-site bleeding. Routine radial artery angiography may improve procedural quality without increase in procedural time or contrast use. Regardless of whether universal or selective radial angiography is best practice, angiography is an important tool to use for efficient radial access.

Hemophilia in the cath lab: Balancing the need to clot with the treatment of thrombosis.

Hemophilia is a rare genetic disorder that inherently results in bleeding risks that can be successfully managed in the cardiac catheterization laboratory. Standard of care options such as drug-coated stents should not be denied hemophiliacs solely on the basis of their genetic defect. Successful care of hemophilia requires a close collaboration with a specialist in these bleeding disorders to optimize care.

Residual damage in previously instrumented radial arteries.

Pre-procedural radial artery ultrasound may reduce both vascular access time and total procedure time in patients who previously had radial artery procedures. Many radial arteries that were previously instrumented appear to have chronic changes that may make them unfavorable for future use. Attention to best practice for radial artery catheterization and measurements of long-term radial artery damage may be important metrics for sustainable, long-term use of transradial access.

Mechanical support for high risk PCI: One pump still doesn't fit all.

Mechanical circulatory support using Impella for high risk PCI is associated with better procedural and hemodynamic outcome compared with IABP although mortality benefit has been elusive. Limited evidence is available to study the effectiveness and safety of mechanical circulatory support in high risk PCI patients and much of it is confounded by underpowered and heterogeneous sample sizes. Lack of randomized trials studying contemporary percutaneous left ventricular assist devices is attributed to difficulty in randomizing high risk patients into trials of hemodynamic support.

Impact of sheath size and hemostasis time on radial artery patency after transradial coronary angiography and intervention in Japanese and non-Japanese patients: A substudy from RAP and BEAT (Radial Artery Patency and Bleeding, Efficacy, Adverse evenT) randomized multicenter trial.

BACKGROUND: During transradial (TR) access, it remains unclear whether differences in baseline patients characteristics and hemostasis care impact the rate of radial artery occlusion (RAO). We sought to compare the rate of RAO after TR access with the 6 French(Fr) Glidesheath Slender (GSS6Fr, Terumo, Japan) or a standard 5 Fr sheath in Japanese and non-Japanese patients. METHODS AND RESULTS: The Radial Artery Patency and Bleeding, Efficacy, Adverse evenT (RAP and BEAT) trial randomized 1,836 patients undergoing TR coronary angiography and/or interventions to receive the GSS6Fr or the standard 5 Fr Glidesheath (GS5Fr, Terumo, Japan). Out of this study population, 1,087 were Japanese patients and 751 non-Japanese patients. The overall incidence of RAO was significantly higher in Japanese patients (3.6% vs. 1.2%, P = 0.002). Use of GSS6Fr was associated with higher rates of RAO than GS5Fr in Japanese patients (5% vs. 2.2%, P = 0.02) and with similar RAO rates in non-Japanese patients (1.3 vs. 1.1%, P = 1). The mean hemostasis time was significantly longer in Japanese patients (378 ± 253 vs. 159 ± 136 min, P < 0.001) and more Japanese patients had a hemostasis time of more than 6 hr (16.2% vs. 4.9%, P < 0.0001). Longer hemostasis time was an independent predictor of RAO (OR per additional hour 1.070, 95% CI 1.008-1.136, P = 0.03). CONCLUSIONS: Use of GSS6Fr was associated with a higher rate of RAO than a standard 5 Fr sheath in Japanese patients but not in non-Japanese patients. Whether improvement in post-procedural care and reduced hemostasis time could impact the incidence of RAO in Japanese patients should be further assessed.

Incidence and Clinical Course of Limb Dysfunction Post Cardiac Catheterization　- A Systematic Review.

BACKGROUND: We systematically reviewed the available literature on limb dysfunction after transradial access (TRA) or transfemoral access (TFA) cardiac catheterization. Methods and Results: MEDLINE and EMBASE were searched for studies evaluating any transradial or transfemoral procedures and limb function outcomes. Data were extracted and results were narratively synthesized with similar treatment arms. The TRA group included 15 studies with 3,616 participants and of these 3 reported nerve damage with a combined incidence of 0.16% and 4 reported sensory loss, tingling and numbness with a pooled incidence of 1.61%. Pain after TRA was the most common form of limb dysfunction (7.77%) reported in 3 studies. The incidence of hand dysfunction defined as disability, grip strength change, power loss or neuropathy was low at 0.49%. Although radial artery occlusion (RAO) was not a primary endpoint for this review, it was observed in 3.57% of the participants in a total of 8 studies included. The TFA group included 4 studies with 15,903,894 participants; the rates of peripheral neuropathy were 0.004%, sensory neuropathy caused by local groin injury and retroperitoneal hematomas were 0.04% and 0.17%, respectively, and motor deficit caused by femoral and obturator nerve damage was 0.13%. CONCLUSIONS: Limb dysfunction post cardiac catheterization is rare, but patients may have nonspecific sensory and motor complaints that resolve over a period of time.