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.

Pulmonary Artery Catheter Use and Risk of In-hospital Death in Heart Failure Cardiogenic Shock.

BACKGROUND: Pulmonary artery catheters (PACs) are increasingly used to guide management decisions in cardiogenic shock (CS). The goal of this study was to determine if PAC use was associated with a lower risk of in-hospital mortality in CS owing to acute heart failure (HF-CS). METHODS AND RESULTS: This multicenter, retrospective, observational study included patients with CS hospitalized between 2019 and 2021 at 15 US hospitals participating in the Cardiogenic Shock Working Group registry. The primary end point was in-hospital mortality. Inverse probability of treatment-weighted logistic regression models were used to estimate odds ratios (ORs) and corresponding 95% confidence intervals (CI), accounting for multiple variables at admission. The association between the timing of PAC placement and in-hospital death was also analyzed. A total of 1055 patients with HF-CS were included, of whom 834 (79%) received a PAC during their hospitalization. In-hospital mortality risk for the cohort was 24.7% (n = 261). PAC use was associated with lower adjusted in-hospital mortality risk (22.2% vs 29.8%, OR 0.68, 95% CI 0.50-0.94). Similar associations were found across SCAI stages of shock, both at admission and at maximum SCAI stage during hospitalization. Early PAC use (≤6 hours of admission) was observed in 220 PAC recipients (26%) and associated with a lower adjusted risk of in-hospital mortality compared with delayed (≥48 hours) or no PAC use (17.3% vs 27.7%, OR 0.54, 95% CI 0.37-0.81). CONCLUSIONS: This observational study supports PAC use, because it was associated with decreased in-hospital mortality in HF-CS, especially if performed within 6 hours of hospital admission. CONDENSED ABSTRACT: An observational study from the Cardiogenic Shock Working Group registry of 1055 patients with HF-CS showed that pulmonary artery catheter (PAC) use was associated with a lower adjusted in-hospital mortality risk (22.2% vs 29.8%, odds ratio 0.68, 95% confidence interval 0.50-0.94) compared with outcomes in patients managed without PAC. Early PAC use (≤6 hours of admission) was associated with a lower adjusted risk of in-hospital mortality compared with delayed (≥48 hours) or no PAC use (17.3% vs 27.7%, odds ratio 0.54, 95% confidence interval 0.37-0.81).

Extracorporeal cardiopulmonary resuscitation for out-of-hospital cardiac arrest: A meta-analysis of randomized controlled trials.

INTRODUCTION: Extracorporeal cardiopulmonary resuscitation (ECPR) is a resuscitation method for patients with refractory out-of-hospital cardiac arrest (OHCA). However, evidence from randomized controlled trials (RCTs) is lacking. METHODS: We searched several electronic databases until March 2023 for RCTs comparing ECPR with conventional CPR in OHCA patients. RevMan 5.4 was used to pool risk ratios (RR) with 95% confidence intervals (CIs). RESULTS: A total of four RCTs were included. The results of our meta-analysis showed no statistically significant benefit of ECPR regarding mid-term survival (RR 1.21; 95% CI 0.64 to 2.28; I2 = 48%; p = .55). We found a significant improvement with ECPR in mid-term favorable neurological outcome (RR 1.59; 95% CI 1.09 to 2.33; I2 = 0%; p = .02). There was no significant difference between ECPR and conventional CPR in long-term survival (RR 1.32; 95% CI 0.18 to 9.50; I2 = 64%; p = .79), and long-term favorable neurological outcome (RR 1.47; 95% CI 0.89 to 2.43; I2 = 25%; p = .13). There was an increased incidence of adverse events in the ECPR group (RR 3.22; 95% CI 1.18 to 8.80; I2 = 63%; p = .02). CONCLUSION: ECPR in OHCA patients was not associated with improved survival or long-term favorable neurological outcome but did improve favorable neurological outcome in the mid-term. However, these results are likely underpowered due to the small number of available RCTs. Large-scale confirmatory RCTs are needed to provide definitive conclusions.

Review of Pathophysiology of Cardiogenic Shock and Escalation of Mechanical Circulatory Support Devices.

PURPOSE OF REVIEW: Cardiogenic shock (CS) is a complex clinical entity that continues to carry a high risk of mortality. The landscape of CS management has changed with the advent of several temporary mechanical circulatory support (MCS) devices designed to provide hemodynamic support. It remains challenging to understand the role of different temporary MCS devices in patients with CS, as many of these patients are critically ill, requiring complex care with multiple MCS device options. Each temporary MCS device can provide different types and levels of hemodynamic support. It is important to understand the risk/benefit profile of each one of them for appropriate device selection in patients with CS. RECENT FINDINGS: MCS may be beneficial in CS patients through augmentation of cardiac output with subsequent improvement of systemic perfusion. Selecting the optimal MCS device depends on several variables including the underlying etiology of CS, clinical strategy of MCS use (bridge to recovery, bridge to transplant or durable MCS, or abridge to decision), amount of hemodynamic support needed, associated respiratory failure, and institutional preference. Furthermore, it is even more challenging to determine the appropriate time to escalate from one MCS device to another or combine different MCS devices. In this review, we discuss the current available data published in the literature on the management of CS and propose a standardized approach for escalation of MCS devices in patients with CS. Shock teams can play an important role to help in hemodynamic-guided management and algorithm-based step-by-step approach in early initiation and escalation of temporary MCS devices at different stages of CS. It is important to define the etiology of CS, and stage of shock and recognize univentricular vs biventricular shock for appropriate device selection and escalation of therapy.

Overview of the FDA's Circulatory System Devices Panel virtual meeting on the TransMedics Organ Care System (OCS) Heart - portable extracorporeal heart perfusion and monitoring system.

There are a limited number of donor hearts available for transplantation every year, and an even lower number of these hearts actually undergo transplantation. One of the barriers to utilizing donor hearts is the inferior outcomes associated with prolonged ischemic times. There have been increasing attempts to develop alternative techniques for prolonged storage to raise the number of heart transplants while maintaining acceptable outcomes. One such new technology utilizes continuous ex vivo perfusion of the donor heart with oxygenated blood and allows for prolonged storage and preservation times. The TransMedics Organ Care System (OCS) Heart (TransMedics; Andover, MA) claims to optimize the condition of the donor organs by preserving them in a warm, functioning environment. On April 6, 2021, the United States Food and Drug Administration convened a virtual meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee to provide guidance on the TransMedics OCS Heart System's application for premarket approval. This application was subsequently approved on September 7, 2021. We provide an overview of the meeting, including the results of the clinical trials that were presented.

Association of HIV infection with clinical features and outcomes of patients with aortic aneurysms.

Data on the characteristics and outcomes of hospitalized patients with aortic aneurysms (AA) and HIV remain scarce. This is a cohort study of hospitalized adult patients with a diagnosis of AA from 2013 to 2019 using the US National Inpatient Readmission Database. Patients with a diagnosis of HIV were identified. Our outcomes included trends in hospitalizations and comparison of clinical characteristics, complications, and mortality in patients with AA and HIV compared to those without HIV. Among 1,905,837 hospitalized patients with AA, 4416 (0.23%) were living with HIV. There was an overall age-adjusted increase in the rate of HIV among patients hospitalized with AA over the years (14-29 per 10,000 person-years; age-adjusted p-trend < 0.001). Patients with AA and HIV were younger than those without HIV (median age: 60 vs 76 years, p < 0.001) and were less likely to have a history of smoking, hypertension, dyslipidemia, diabetes mellitus, and obesity. Thoracic aortic aneurysms were more prevalent in those with HIV (37.5% vs 26.7%, p < 0.001). On multivariable logistic regression, HIV was not associated with increased risk of aortic rupture (OR: 0.79; 95% CI: 0.61-1.01, p = 0.06), acute aortic dissection (OR: 0.73; 95% CI: 0.51-1.06, p = 0.3), readmissions (OR: 1.04; 95% CI: 0.95-1.13, p = 0.4), or aortic repair (OR: 0.89; 95% CI: 0.79-1.00, p = 0.05). Hospitalized patients with AA and HIV had a lower crude mortality rate compared to those without HIV (OR: 0.75 (0.63-0.91), p = 0.003). Hospitalized patients with AA and HIV likely constitute a distinct group of patients with AA; they are younger, have fewer traditional cardiovascular risk factors, and a higher rate of thoracic aorta involvement. Differences in clinical features may account for the lower mortality rate observed in patients with AA and HIV compared to those without HIV.

Association of autosomal dominant polycystic kidney disease with cardiovascular disease: a US-National Inpatient Perspective.

PURPOSE: Data on the epidemiology of cardiovascular diseases (CVD) in patients with autosomal dominant polycystic kidney disease (ADPKD) are limited. In this study, we assess the prevalence of CVD in patients with ADPKD and evaluate associations between these two entities. METHODS: Using the National Inpatient Sample database, we identified 71,531 hospitalizations among adults aged ≥ 18 years with ADPKD, from 2006 to 2014 and collected relevant clinical data. RESULTS: The prevalence of CVD in the study population was 42.6%. The most common CVD were ischemic heart diseases (19.3%), arrhythmias (14.2%), and heart failure (13.1%). The prevalence of CVD increased with the severity of renal dysfunction (RD). We found an increase in hospitalizations of patients with ADPKD and CVD over the years (ptrend < 0.01), irrespective of the degree of RD. CVD was the greatest independent predictor of mortality in these patients (OR: 3.23; 95% CI 2.38-4.38 [p < 0.001]). In a propensity matched model of hospitalizations of patients with CKD with and without ADPKD, there was a significant increase in the prevalence of atrial fibrillation/flutter (AF), pulmonary hypertension (PHN), non-ischemic cardiomyopathy (NICM), and hemorrhagic stroke among patients with ADPKD when compared to patients with similar degree of RD without ADPKD. CONCLUSIONS: The prevalence of CVD is high among patients with ADPKD, and the most important risk factor associated with CVD is severity of RD. We found an increase in the trend of hospitalizations of patients with ADPKD associated with increased risk of AF, PHN, NICM, and hemorrhagic stroke. History of CVD is the strongest predictor of mortality among patients with ADPKD.

Lactate Clearance Is Associated With Improved Survival in Cardiogenic Shock: A Systematic Review and Meta-Analysis of Prognostic Factor Studies.

OBJECTIVE: Elevated blood lactate levels are strongly associated with mortality in patients with cardiogenic shock. Recent evidence suggests that the degree and rate at which blood lactate levels decrease after the initiation of treatment may be equally important in patient prognosis. We performed a systematic review and meta-analysis to evaluate the usefulness of lactate clearance as a prognostic factor in cardiogenic shock. METHODS AND RESULTS: We performed searches of Ovid MEDLINE, Elsevier EMBASE, EBM Reviews-Cochrane Central Register of Controlled Trials, and Web of Science to identify studies comparing lactate clearance between survivors and nonsurvivors at one or more timepoints. Both prospective and retrospective studies were eligible for inclusion. Two study investigators independently screened, extracted data, and assessed the quality of all included studies. Twelve studies were included in the meta-analysis. The median lactate clearance at 6-8 hours was 21.9% (interquartile range [IQR] 14.6%-42.1%) in survivors and 0.6% (IQR -3.7% to 14.6%) in nonsurvivors. At 24 hours, the median lactate clearance was 60.7% (IQR 58.1%-76.3%) and 40.3% (IQR 30.2%-55.8%) in survivors and nonsurvivors, respectively. Accordingly, the pooled mean difference in lactate clearance between survivors and nonsurvivors at 6-8 hours was 17.3% (95% CI 11.6%-23.1%, P < .001) at 6-8 hours and 27.9% (95% CI 14.1%-41.7%, P < .001) at 24 hours. CONCLUSIONS: Survivors had significantly greater lactate clearance at 6-8 hours and at 24 hours compared with nonsurvivors, suggesting that lactate clearance is an important prognostic marker in cardiogenic shock.

Heart Failure-Related Cardiogenic Shock: Pathophysiology, Evaluation and Management Considerations: Review of Heart Failure-Related Cardiogenic Shock.

Despite increasing prevalence in critical care units, cardiogenic shock related to HF (HF-CS) is incompletely understood and distinct from acute myocardial infarction related CS. This review highlights the pathophysiology, evaluation, and contemporary management of HF-CS.

Right Ventricular Pressure-Volume Analysis During Left Ventricular Assist Device Speed Optimization Studies: Insights Into Interventricular Interactions and Right Ventricular Failure.

BACKGROUND: Interventricular interaction, which refers to the impact of left ventricular (LV) function on right ventricular (RV) function and vice versa, has been implicated in the pathogenesis of RV failure in LV assist device (LVAD) recipients. We sought to understand more about interventricular interaction by quantifying changes in the RV systolic and diastolic function with varying LVAD speeds. METHODS AND RESULTS: Four patients (ages 22-69 years, 75% male, and 25% with ischemic cardiomyopathy) underwent a protocolized hemodynamic ramp test within 12 months of LVAD implantation where RV pressure-volume loops were recorded with a conductance catheter. The end-systolic PV relationship and end-diastolic PV relationship were compared using the V20 and V10 indices (volumes at which end-systolic PV relationship and end-diastolic PV relationship reach a pressure of 20 and 10 mm Hg, respectively). The ∆V20 and ∆V10 refer to the change in V20 and V10 from the minimum to maximum LVAD speeds. RV PV loops demonstrated variable changes in systolic and diastolic function with increasing LVAD speed. The end-systolic PV relationship changed in 1 patient (patient 2, ∆V20 = 23.5 mL), reflecting a decrease in systolic function with increased speed, and was unchanged in 3 patients (average ∆V20 = 7.4 mL). The end-diastolic PV relationship changed with increasing speed in 3 of 4 patients (average ∆V10 = 12.5 mL), indicating an increase in ventricular compliance, and remained unchanged in one participant (patient 1; ∆V10 = 4.0 mL). CONCLUSIONS: Interventricular interaction can improve RV compliance and impair systolic function, but the overall effect on RV performance in this pilot investigation is heterogeneous. Further research is required to understand which patient characteristics and hemodynamic parameters influence the net impact of interventricular interaction.

Right Ventricular Dysfunction Is Common and Identifies Patients at Risk of Dying in Cardiogenic Shock.

BACKGROUND: Understanding the prognostic impact of right ventricular dysfunction (RVD) in cardiogenic shock (CS) is a key step toward rational diagnostic and treatment algorithms and improved outcomes. Using a large multicenter registry, we assessed (1) the association between hemodynamic markers of RVD and in-hospital mortality, (2) the predictive value of invasive hemodynamic assessment incorporating RV evaluation, and (3) the impact of RVD severity on survival in CS. METHODS AND RESULTS: Inpatients with CS owing to acute myocardial infarction (AMI) or heart failure (HF) between 2016 and 2019 were included. RV parameters (right atrial pressure, right atrial/pulmonary capillary wedge pressure [RA/PCWP], pulmonary artery pulsatility index [PAPI], and right ventricular stroke work index [RVSWI]) were assessed between survivors and nonsurvivors, and between etiology and SCAI stage subcohorts. Multivariable logistic regression analysis determined hemodynamic predictors of in-hospital mortality; the resulting models were compared with SCAI staging alone. Nonsurvivors had a significantly higher right atrial pressure and RA/PCWP and lower PAPI and RVSWI than survivors, consistent with more severe RVD. Compared with AMI, patients with HF had a significantly lower RA/PCWP (0.58 vs 0.66, P = .001) and a higher PAPI (2.71 vs 1.78, P < .001) and RVSWI (5.70 g-m/m2 vs 4.66 g-m/m2, P < .001), reflecting relatively preserved RV function. Paradoxically, multiple RVD parameters (PAPI, RVSWI) were associated with mortality in the HF but not the AMI cohort. RVD was more severe with advanced SCAI stage, although its prognostic value was progressively diluted in stages D and E. Multivariable modelling incorporating the RA/PCWP improved the predictive value of SCAI staging (area under the curve [AUC] 0.78 vs 0.73, P < .001), largely driven by patients with HF (AUC 0.82 vs 0.71, P < .001). CONCLUSIONS: RVD is associated with poor outcomes in CS, with key differences across etiology and shock severity. Further studies are needed to assess the usefulness of RVD assessment in guiding therapy.

Incidence and clinical outcomes of bleeding complications and acute limb ischemia in STEMI and cardiogenic shock.

BACKGROUND: Bleeding complications and acute limb ischemia (ALI) are devastating vascular complications in patients with ST-segment elevation myocardial infarction (STEMI). Cardiogenic shock (CS) can further increase this risk due to multiorgan failure. In the contemporary era, percutaneous mechanical circulatory support is commonly used for management of CS. We hypothesized that vascular complications may be an important determinant of clinical outcomes for CS due to STEMI (CS-STEMI). OBJECTIVE: We evaluated 10-year national trends, resource utilization and outcomes of bleeding complications, and ALI in CS-STEMI. METHODS: We performed a retrospective cohort study of CS-STEMI patients from a large U.S. national database (National Inpatient Sample) between 2005 and 2014. Events were then divided into four different groups: no MCS, with intra-aortic balloon pump, percutaneous ventricular assist device includes Impella or Tandem Heart or extracorporeal membrane oxygenation. RESULTS: Bleeding complications and ALI were observed in 31,389 (18.2%) and 1,628 (0.9%) out of 172,491 admissions with CS-STEMI, respectively. Between 2005 and 2014, overall trends increased for ALI; however, the number of bleeding events decreased. ALI was associated with increased in-hospital mortality in comparison to those without any ALI. However, bleeding complications were not associated with increased in-hospital mortality. Compared to patients without complications, both bleeding and ALI were associated with increased length of stay (LOS) and hospitalization costs. CONCLUSIONS: Bleeding and ALI are common complications associated with CS-STEMI in the contemporary era. Both complications are associated with increased hospital costs and LOS. These findings highlight the need to develop algorithms focused on vascular safety in CS-STEMI.

Incidence and clinical outcomes of stroke in ST-elevation myocardial infarction and cardiogenic shock.

OBJECTIVE: The authors sought to evaluate 10-year national trends, incidence and clinical outcomes of stroke in CS-STEMI. BACKGROUND: Stroke is a devastating complication among patients with ST-elevation myocardial infarction (STEMI). Concomitant cardiogenic shock (CS) may further increase the risk of stroke. Use of percutaneous mechanical circulatory support (pMCS) devices may further increase stroke risk in CS-STEMI. No studies have evaluated the risk of stroke in contemporary CS-STEMI. METHODS: We performed a retrospective cohort study of CS-STEMI patients from a large U.S. national database between 2005 and 2014. Previously validated codes for stroke were used to identify events of ischemic or hemorrhagic stroke. They were then divided into different groups: without MCS, with intra-aortic balloon pump, percutaneous ventricular assist device (PVAD, includes Impella or TandemHeart devices), or extracorporeal membrane oxygenation. RESULTS: In 172,491 admissions, stroke was noted in 5,613 (3.2%). Between 2005 and 2014, we observed an increase in the events of overall stroke from 3.1% in 2005 to 5.0% in 2014 (p for the trend <.001). The number of ischemic stroke events (2.4%) was higher than hemorrhagic stroke (0.1%) during the study period. Presence of stroke was associated with higher in-hospital mortality (40.6 vs. 29.8%, 95% CI adjusted odds ratio: 1.57, 1.44-1.67; p < .0001 among stroke vs. without stroke). CONCLUSIONS: The incidence of stroke events in CS-STEMI patients increased between 2005 and 2014, and is associated with higher in-hospital mortality, length of stay, and cost of hospitalization. The incidence of both hemorrhagic and ischemic stroke was higher with pMCS device use. Stroke prevention is a priority for CS-STEMI patients.

Trends in the Incidence of In-Hospital Mortality, Cardiogenic Shock, and Utilization of Mechanical Circulatory Support Devices in Myocarditis (Analysis of National Inpatient Sample Data, 2005-2014).

BACKGROUND: Myocarditis may be associated with hemodynamic instability and portends a poor prognosis when associated with cardiogenic shock (CS). There are limited data available on the incidence of in-hospital mortality, CS, and utilization of mechanical circulatory support (MCS) devices in these patients. METHODS: We queried the 2005-2014 National Inpatient Sample databases to identify all patients aged >18 years with myocarditis in the United States. RESULTS: The number of reported cases of myocarditis per 1 million gradually increased from 95 in 2005 to 144 in 2014 (Pfor trend <.01). The trend and incidence of endomyocardial biopsy remained the same despite the increase in clinical diagnosis. Overall, in-hospital mortality was 4.43% of total admissions without a change in overall trend over the study period. We also observed a significant increase in the incidence of CS from 6.94% in 2005 to 11.99% in 2014 (Pfor trend <.01). There was a parallel increase in the utilization of advanced MCS devices during the same time period such as extracorporeal membrane oxygenation or percutaneous cardiopulmonary support (0.32% in 2005 to 2.1% in 2014; P< .01) and percutaneous ventricular assist devices such as Impella/tandem heart (0.176% in 2005 to 1.75% in 2014; P< .01). CONCLUSION: Although the incidence of myocarditis has increased in the last decade, the in-hospital mortality has remained the same despite increases in the incidence of CS, possibly reflecting the benefits of increased usage of advanced MCS devices. We noted that increasing age, presence of multiple comorbidities and CS were associated with an increase in in-patient mortality.

Aspirin Resistance: Cardiovascular Risk Game Changer.

BACKGROUND: Aspirin (ASA) is the most used medication on the globe. ASA is a primary pillar of the secondary prevention of cardiovascular atherothromboembolic events. However, a fraction of the population does not respond to ASA as expected in a unique phenomenon called ASA resistance. Multiple mechanisms were described and studied in the literature to explain this phenomenon. AREA OF UNCERTAINTY: ASA resistance is an interesting phenomenon that is worth studying and reviewing. Mechanisms behind this resistance are various and although the rarity of some, it is crucial for the modern health provider to be aware of such phenomenon and its possible explanations to provide more efficient preventive cardiology practice. Our study aimed to review and conclude the evidence behind ASA resistance and its implication on the cardiovascular health. DATA SOURCES: We searched databases like PubMed, EMBASE, Ovid by midline, and Google Scholar for published articles and abstracts. RESULTS: Our systemic search revealed more than 100 articles in relation to ASA resistance. We selected 40 articles, which were relevant for this review. Various mechanisms were described in the literature, with few of them very well documented and understood. Main mechanisms include medication nonadherence, interaction with proton pump inhibitors, esterase-mediated ASA inactivation, post-coronary artery bypass grafting (CABG) MRP-4-mediated ASA consumption, cyclooxygenase-1 (COX-1) polymorphisms, high platelet turnover-associated regeneration of platelet COX-1, and the documented platelet ability of de novo COX-1 synthesis in response to thrombin and fibrinogen. CONCLUSION: Multiple mechanisms of ASA resistance were described in the literature. Awareness of such interaction is important for medical practitioners. Bottom line, further studies and reviews are needed to further study this phenomenon and its implication on the cardiovascular health and hence reaching a valid evidence-based conclusion that might change the practice and improve the patient preventive health care.

Severe right ventricular hypertrophy in a patient with extracardiac and intracardiac shunt.

Cardiac MRI is a complementary and confirmatory modality to a clinical echocardiography in diagnosing patients with complex adult congenital heart disease, especially in presence of great vessel abnormalities. We present a unique case of a patient with pulmonary hypertension (PH), severe right ventricular hypertrophy, Gerbode defect, and a large patent ductus arteriosus (PDA). The diagnosis of PDA was not visualized on prior serial echocardiograms and discovered on a comprehensive cardiac MRI/Chest MR angiogram.

Transradial stenting of left subclavian artery origin using shockwave intravascular lithotripsy balloon plasty: Technical report and literature review.

Lesions of the subclavian artery often involve pathologic stenosis due to high degrees of calcification within the vessel wall. While endovascular angioplasty and stenting is generally the preferred method for obtaining flow reconstitution, calcification of the vessel wall has proven to significantly impair the efficacy of successful stent deployment. Shockwave intravascular lithotripsy (IVL) is a technology that has been very successful in addressing this challenge in other vascular territories, however its use has yet to be approved for supra-aortic vessels such as the subclavian artery. In this report, the use of IVL for a case of subclavian steal syndrome due to a highly stenosed left subclavian artery is described along with a review of the literature. Although several cases utilizing this technology in subclavian arteries have been reported, none have described the use of a left transradial approach. Therefore the purpose of this report is to demonstrate the efficacy of IVL for supra-aortic vessels so that its benefits can be expanded to a broader patient population.

Delaying reperfusion plus left ventricular unloading reduces infarct size: Sub-analysis of DTU-STEMI pilot study.

INTRODUCTION: The STEMI-DTU pilot study tested the early safety and practical feasibility of left ventricular (LV) unloading with a trans-valvular pump before reperfusion. In the intent-to-treat cohort, no difference was observed for microvascular obstruction (MVO) or infarct size (IS) normalized to either the area at risk (AAR) at 3-5 days or total LV mass (TLVM) at 3-5 days We now report a per protocol analysis of the STEMI-DTU pilot study. METHODS: In STEMI-DTU STUDY 50 adult patients (25 in each arm) with anterior STEMI [sum of precordial ST-segment elevation (ΣSTE) ≥4 mm] requiring primary percutaneous coronary intervention (PCI) were enrolled. Only patients who met all inclusion and exclusion criteria were included in this analysis. Cardiac magnetic resonance (CMR) imaging 3-5 days after PCI quantified IS/AAR and IS/TLVM and MVO. Group differences were assessed using Student's t-tests and linear regression (SAS Version-9.4). RESULTS: Of the 50 patients enrolled, 2 died before CMR imaging. Of the remaining 48 patients those without CMR at 3-5 days (n = 8), without PCI of a culprit left anterior descending artery lesion (n = 2), with OHCA (n = 1) and with ΣSTE < 4 mm (n = 5) were removed from this analysis leaving 32/50 (64 %) patients meeting all inclusion and exclusion criteria (U-IR, n = 15; U-DR, n = 17) as per protocol. Despite longer symptom-to-balloon times in the U-DR arm (228 ± 80 vs 174 ± 59 min, p < 0.01), IS/AAR was significantly lower with 30 min of delay to reperfusion in the presence of active LV unloading (47 ± 16 % vs 60 ± 15 %, p = 0.02) and remained lower irrespective of the magnitude of precordial ΣSTE. MVO was not significantly different between groups (1.5 ± 2.8 % vs 3.5 ± 4.8 %, p = 0.15). Among patients who received LV unloading within 180 min of symptom onset, IS/AAR was significantly lower in the U-DR group. CONCLUSION: In this per-protocol analysis of the STEMI-DTU pilot study we observed that LV unloading for 30 min before reperfusion significantly reduced IS/AAR compared to LV unloading and immediate reperfusion, whereas in the ITT cohort no difference was observed between groups. This observation supports the design of the STEMI-DTU pivotal trial and suggests that strict adherence to the study protocol can significantly influence the outcome.

Factors associated with Acute Limb Ischemia in Cardiogenic Shock and downstream Clinical Outcomes: Insights from the Cardiogenic Shock Working Group.

BACKGROUND: There are limited data depicting the prevalence and ramifications of acute limb ischemia (ALI) among cardiogenic shock (CS) patients. METHODS: We employed data from the Cardiogenic Shock Working Group (CSWG), a consortium including 33 sites. We constructed a multi-variable logistic regression to examine the association between clinical factors and ALI, we generated another logistic regression model to ascertain the association of ALI with mortality. RESULTS: There were 7,070 patients with CS and 399 (5.6%) developed ALI. Patients with ALI were more likely to be female (40.4% versus 29.4%) and have peripheral arterial disease (13.8% versus 8.3%). Stratified by maximum SCAI shock stage, the rates of ALI were stage B 0.0%, stage C 1.8%, stage D 4.1%, and stage E 10.3%. Factors associated with higher risk for ALI included: peripheral vascular disease OR 2.24 (95% CI: 1.53 - 3.23; p < 0.01) and ≥ 2 mechanical circulatory support (MCS) devices OR 1.66 (95% CI: 1.24 - 2.21, p < 0.01). ALI was highest for VA-ECMO patients (11.6%) or VA-ECMO + IABP/Impella CP (16.6%) yet use of distal perfusion catheters was less than 50%. Mortality was 38.0% for CS patients without ALI but 57.4% for CS patients with ALI. ALI was significantly associated with mortality, adjusted OR 1.40 (95% CI 1.01 - 1.95, p < 0.01). CONCLUSIONS: The rate of ALI was 6% among CS patients. Factors most associated with ALI include peripheral vascular disease and multiple MCS devices. The downstream ramifications of ALI were dire with a considerably higher risk of mortality.