Influence of left ventricular ejection fraction in patients undergoing contemporary pLVAD-supported high-risk PCI.

BACKGROUND: Left ventricular (LV) systolic dysfunction worsens outcomes in patients undergoing percutaneous coronary intervention (PCI). The objective of this study, therefore, was to evaluate outcomes of pLVAD-supported high-risk PCI (HRPCI) patients according to LV ejection fraction (LVEF). METHODS: Patients from the PROTECT III study undergoing pLVAD-supported HRPCI were stratified according to baseline LVEF: severe LV dysfunction (LVEF <30%), mild and moderate LV dysfunction (LVEF ≥30% to <50%), or preserved LV function (LVEF ≥50%). Major adverse cardiovascular and cerebrovascular events (MACCE: composite of all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization), and PCI-related complications were assessed at 90 days and mortality was assessed at 1-year. RESULTS: From March 2017 to March 2020, 940 patients had evaluable baseline LVEF recorded in the study database. Patients with preserved LV function were older, more frequently presented with myocardial infarction, and underwent more left main PCI and atherectomy. Immediate PCI-related coronary complications were infrequent (2.7%, overall), similar between groups (P = 0.98), and not associated with LVEF. Unadjusted 90-day MACCE rates were similar among LVEF groups; however, as a continuous variable, LVEF was associated with both 90-day MACCE (adj.HR per 5% 0.89, 95% CI [0.80, 0.98], P = 0.018) and 1-year mortality (adj.HR per 5% 0.84 [0.78, 0.90], P <0.0001). CONCLUSIONS: Patients who underwent pLVAD-supported HRPCI exhibited low incidence of PCI-related complications, regardless of baseline LVEF. However, LVEF was associated with 90-day MACCE and 1-year mortality.

Angiographic characteristics of patients with STEMI and COVID-19: Insights from NACMI registry.

BACKGROUND: To date, there has been no independent core lab angiographic analysis of patients with COVID-19 and STEMI. The study characterized the angiographic parameters of patients with COVID-19 and STEMI. METHODS: Angiograms of patients with COVID-19 and STEMI from the North American COVID-19 Myocardial Infarction (NACMI) Registry were sent to a Core Laboratory in Vancouver, Canada. Culprit lesion(s), Thrombolysis In Myocardial Infarction (TIMI) flow, Thrombus Grade Burden (TGB), and percutaneous coronary intervention (PCI) outcome were assessed. RESULTS: From 234 patients, 74% had one culprit lesion, 14% had multiple culprits and 12% had no culprit identified. Multivessel thrombotic disease and multivessel CAD were found in 27% and 53% of patients, respectively. Stent thrombosis accounted for 12% of the presentations and occurred in 55% of patients with previous coronary stents. Of the 182 who underwent PCI, 60 (33%) had unsuccessful PCI due to post-PCI TIMI flow <3 (43/60), residual high thrombus burden (41/60) and/or thrombus related complications (27/60). In-hospital mortality for successful, partially successful, and unsuccessful PCI was 14%, 13%, and 27%, respectively. Unsuccessful PCI was associated with increased risk of in-hospital mortality (risk ratio [RR] 1.96; 95% CI: 1.05-3.66, P = .03); in the adjusted model this estimate was attenuated (RR: 1.24; 95% CI: 0.65-2.34, P = .51). CONCLUSION: In patients with COVID-19 and STEMI, thrombus burden was pervasive with notable rates of multivessel thrombotic disease and stent thrombosis. Post-PCI, persistent thrombus and sub-optimal TIMI 3 flow rates led to one-third of the PCI's being unsuccessful, which decreased over time but remained an important predictor of in-hospital mortality.

Mechanical Complication of Acute Myocardial Infarction Secondary to COVID-19 Disease.

The aggressive inflammatory response to COVID-19 can result in airway damage, respiratory failure, cardiac injury, and multiorgan failure, which lead to death in susceptible patients. Cardiac injury and acute myocardial infarction (AMI) secondary to COVID-19 disease can lead to hospitalization, heart failure, and sudden cardiac death. When serious collateral damage from tissue necrosis or bleeding occurs, mechanical complications of myocardial infarction and cardiogenic shock can ensue. While prompt reperfusion therapies have decreased the incidence of these serious complications, patients who present late following the initial infarct are at increased for mechanical complications, cardiogenic shock, and death. The health outcomes for patients with mechanical complications are dismal if not recognized and treated promptly. Even if they survive serious pump failure, their CICU stay is often prolonged, and their index hospitalization and follow-up visits may consume significant resources and impact the health care system.

Improved outcomes in patients with severely depressed LVEF undergoing percutaneous coronary intervention with contemporary practices.

BACKGROUND: Contemporary practices for hemodynamically supported high-risk percutaneous coronary intervention have evolved over the last decade. This study sought to compare outcomes of the prospective, multicenter, PROTECT III study to historic patients treated with Impella in the PROTECT II randomized controlled trial. METHODS: Of 1,134 patients enrolled in PROTECT III from March 2017 to March 2020, 504 were "PROTECT II-like" (met eligibility for PROTECT II randomized controlled trial) and are referred to as PROTECT III for comparative analysis. Major adverse cardiac and cerebrovascular events (MACCE), comprising all-cause mortality, stroke/transient ischemic attack, myocardial infarction, and repeat revascularization, were compared at hospital discharge and 90 days. RESULTS: Compared with PROTECT II (N = 216), PROTECT III patients were less often Caucasian (77.1% vs 83.8%, P = .045), with less prior CABG (13.7% vs 39.4%; P < .001) and prior myocardial infarction (40.7% vs 69.3%; P < .001). More PROTECT III patients underwent rotational atherectomy (37.1% vs 14.8%, P < .001) and duration of support was longer (median 1.6 vs 1.3 hours; p<0.001), with greater improvement achieved in myocardial ischemia jeopardy scores (7.0±2.4 vs 4.4±2.9; P < .001) and SYNTAX scores (21.4±10.8 vs 15.7±9.5; P < .001). In-hospital bleeding requiring transfusion was significantly lower in PROTECT III (1.8% vs 9.3%; P < .001), as was procedural hypotension (2.2% vs 10.1%; P < .001) and cardiopulmonary resuscitation or ventricular arrhythmia (1.6% vs 6.9%; P < .001). At 90 days, MACCE was 15.1% and 21.9% in PROTECT III and PROTECT II, respectively (p=0.037). Following propensity score matching, Kaplan-Meier analysis showed improved 90-day MACCE rates in PROTECT III (10.4% vs 16.9%, P = .048). CONCLUSIONS: The PROTECT III study demonstrates improved completeness of revascularization, less bleeding, and improved 90-day clinical outcomes compared to PROTECT II for Impella-supported high-risk percutaneous coronary intervention among patients with severely depressed LVEF.

Turndown for coronary artery bypass surgery: Never say never to revascularization.

In this issue of Catheterization and Cardiovascular Interventions, Farag et al. reported their experience comparing patients with acute coronary syndrome versus stable angina patients who were turned down for bypass surgery and subsequently treated with coronary stenting (1).

Age stratified sex-related differences in incidence, management, and outcomes of cardiogenic shock.

BACKGROUND: There is a lack of data on age-stratified sex differences in the incidence, treatment, and outcomes of cardiogenic shock (CS). We sought to study these differences from a contemporary database. METHODS: Patients admitted with CS (2004-2018) were identified from the United States National Inpatient Sample. We compared CS (acute myocardial infarction-related cardiogenic shock [AMI-CS] and non-acute myocardial infarction-related cardiogenic shock [Non-AMI-CS]) incidence, management, and outcomes in males and females, stratified into four age groups (20-44, 45-64, 65-84, and ≥85 years of age). Propensity score matching (PSM) was used for adjustment. RESULTS: A total of 1,506,281 weighted hospitalizations for CS were included (AMI-CS, 39%; Non-AMI-CS, 61%). Across all age groups, females had a lower incidence of CS compared with males. After PSM and among the AMI-CS cohort, higher mortality among females compared with males was observed in the age groups 45-64 (28.5% vs. 26.3%) and 65-84 years (39.3% vs. 37.9%) (p < 0.01, for all). Among the Non-AMI-CS cohort, higher mortality among females compared with males was observed in the age groups 20-44 (33.5% vs. 30.5%), 45-64 (35.1% vs. 31.9%), and 65-84 years (41.7% vs. 40.3%) (p < 0.01, for all). Similar age-dependent differences in the management of CS were also observed between females and males. CONCLUSIONS: Females have a lower incidence of CS regardless of age. Significant disparities in the management and outcomes of CS were observed based on sex. However, these disparities varied by age and etiology of CS (AMI-CS vs. Non-AMI-CS) with pronounced disparity among females in the age range of 45-84 years.

ST-Segment Elevation Myocardial Infarction: Sex Differences in Incidence, Etiology, Treatment, and Outcomes.

PURPOSE: Although there have been marked improvements in the standard of care for treatment of ST-elevation myocardial infarction, women, especially younger women, continue to have significantly worse outcomes than men. RECENT FINDINGS: This review highlights the current sex differences in presentation, etiology, treatment, and outcomes among these patients in order to make providers aware of the heterogeneous entities that cause ST-elevation myocardial infarction particularly in women and of disparities in treatment that lead to poorer outcomes in women. Furthermore, it emphasizes evidence-based strategies including standardized protocols for early revascularization, mechanical circulatory support, and access methodology that can reduce sex-based disparities in treatments and outcomes.

Between a rock and a hard place: Orbital atherectomy for under-expanded stents.

Stent under-expansion (rather than intimal hyperplasia) may be the cause of in-stent restenosis. Later expansion of coronary stents that were not fully deployed initially, can be difficult. Atherectomy is one method of facilitating late stent expansion, but too few patients have been treated to determine the risk benefit ratio.

STEMI telemedicine for 100 million lives.

BACKGROUND: Developing countries struggle to diagnose and treat ST-segment elevation myocardial infarction (STEMI) patients in a timely manner, and subsequent outcomes are suboptimal. METHODS: The Latin America Telemedicine Network (LATIN) functioned between 2013 to present in four countries-Brazil, Colombia, Mexico, and Argentina. A Hub and Spoke platform was developed to expand access to >100 million population for STEMI care. Patients were triaged at spokes that included small clinics and primary health care centers in remote South American locations. Three telemedicine command sites provided immediate 24/7 electrocardiogram diagnosis and teleconsultation of the STEMI process at 355 centers in four countries. RESULTS: LATIN Spokes (n = 313) screened up to 30,000 patients per month, and a total of 780,234 patients over the study period. Telemedicine experts diagnosed 8395 (1·1%) with STEMI, of which a total of 3872 (46·1%) were urgently treated at 47 Hubs. A total of 3015 patients (78%) were reperfused with percutaneous coronary intervention. Time-to-telemedicine diagnosis averaged 3·5 min. Average door-to-balloon time improved from 120 to 48 min during the study period and overall STEMI mortality was 5·2%. INTERPRETATION: Telemedicine transcends boundaries and enables access to millions of patients for STEMI care. With this initiative, LATIN has created a template for reducing disparities in STEMI management between developed and developing countries.

The DISCO study-Does Interventionalists' Sex impact Coronary Outcomes?

OBJECTIVES: To examine the association of operator sex with appropriateness and outcomes of percutaneous coronary intervention (PCI). BACKGROUND: Recent studies suggest that physician sex may impact outcomes for specific patient cohorts. There are no data evaluating the impact of operator sex on PCI outcomes. METHODS: We studied the impact of operator sex on PCI outcome and appropriateness among all patients undergoing PCI between January 2010 and December 2017 at 48 non-federal hospitals in Michigan. We used logistic regression models to adjust for baseline risk among patients treated by male versus female operators in the primary analysis. RESULTS: During this time, 18 female interventionalists and 385 male interventionalists had performed at least one PCI. Female interventionalists performed 6362 (2.7%) of 239,420 cases. There were no differences in the odds of mortality (1.48% vs. 1.56%, adjusted OR [aOR] 1.138, 95% CI: 0.891-1.452), acute kidney injury (3.42% vs. 3.28%, aOR 1.027, 95% CI: 0.819-1.288), transfusion (2.59% vs. 2.85%, aOR 1.168, 95% CI: 0.980-1.390) or major bleeding (0.95% vs. 1.07%, aOR 1.083, 95% CI: 0.825-1.420) between patients treated by female versus male interventionalist. While the absolute differences were small, PCIs performed by female interventional cardiologists were more frequently rated as appropriate (86.64% vs. 84.45%, p-value <0.0001). Female interventional cardiologists more frequently prescribed guideline-directed medical therapy. CONCLUSIONS: We found no significant differences in risk-adjusted in-hospital outcomes between PCIs performed by female versus male interventional cardiologists in Michigan. Female interventional cardiologists more frequently performed PCI rated as appropriate and had a higher likelihood of prescribing guideline-directed medical therapy.

Racial and ethnic disparities in coronary, vascular, structural, and congenital heart disease.

Cardiovascular disease (CVD) remains the leading cause of death in the United States. However, percutaneous interventional cardiovascular therapies are often underutilized in Blacks, Hispanics, and women and may contribute to excess morbidity and mortality in these vulnerable populations. The Society for Cardiovascular Angiography and Interventions (SCAI) is committed to reducing racial, ethnic, and sex-based treatment disparities in interventional cardiology patients. Accordingly, each of the SCAI Clinical Interest Councils (coronary, peripheral, structural, and congenital heart disease [CHD]) participated in the development of this whitepaper addressing disparities in diagnosis, treatment, and outcomes in underserved populations. The councils were charged with summarizing the available data on prevalence, treatment, and outcomes and elucidating potential reasons for any disparities. Given the huge changes in racial and ethnic composition by age in the United States (Figure 1), it was difficult to determine disparities in rates of diagnosis and we expected to find some racial differences in prevalence of disease. For example, since the average age of patients undergoing transcatheter aortic valve replacement (TAVR) is 80 years, one may expect 80% of TAVR patients to be non-Hispanic White. Conversely, only 50% of congenital heart interventions would be expected to be performed in non-Hispanic Whites. Finally, we identified opportunities for SCAI to advance clinical care and equity for our patients, regardless of sex, ethnicity, or race.

Hot topics in interventional cardiology: Proceedings from the society for cardiovascular angiography and interventions (SCAI) 2021 think tank.

The Society for Cardiovascular Angiography and Interventions (SCAI) Think Tank is a collaborative venture that brings together interventional cardiologists, administrative partners, and select members of the cardiovascular industry community annually for high-level field-wide discussions. The 2021 Think Tank was organized into four parallel sessions reflective of the field of interventional cardiology: (a) coronary intervention, (b) endovascular medicine, (c) structural heart disease, and (d) congenital heart disease. Each session was moderated by a senior content expert and co-moderated by a member of SCAI's Emerging Leader Mentorship program. This document presents the proceedings to the wider cardiovascular community in order to enhance participation in this discussion, create additional dialog from a broader base, and thereby aid SCAI, the industry community and external stakeholders in developing specific action items to move these areas forward.

North American COVID-19 ST-Segment-Elevation Myocardial Infarction (NACMI) registry: Rationale, design, and implications.

The novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), that causes coronavirus disease 2019 (COVID-19), has resulted in a global pandemic. Patients with cardiovascular risk factors or established cardiovascular disease are more likely to experience severe or critical COVID-19 illness and myocardial injury is a key extra-pulmonary manifestation. These patients frequently present with ST-elevation on an electrocardiogram (ECG) due to multiple etiologies including obstructive, non-obstructive, and/or angiographically normal coronary arteries. The incidence of ST-elevation myocardial infarction (STEMI) mimics in COVID-19-positive hospitalized patients, and the association with morbidity and mortality is unknown. Understanding the natural history and appropriate management of COVID-19 patients presenting with ST elevation is essential to inform patient management decisions and protect healthcare workers. Methods: The Society for Cardiovascular Angiography and Interventions (SCAI) and The Canadian Association of Interventional Cardiology (CAIC) in conjunction with the American College of Cardiology Interventional Council have collaborated to create a multi-center observational registry, NACMI. This registry will enroll confirmed COVID-19 patients and persons under investigation (PUI) with new ST-segment elevation or new onset left bundle branch block (LBBB) on the ECG with clinical suspicion of myocardial ischemia. We will compare demographics, clinical findings, outcomes and management of these patients with a historical control group of over 15,000 consecutive STEMI activation patients from the Midwest STEMI Consortium using propensity matching. The primary clinical outcome will be in- hospital major adverse cardiovascular events (MACE) defined as composite of all-cause mortality, stroke, recurrent MI, and repeat unplanned revascularization in COVID-19 confirmed or PUI. Secondary outcomes will include the following: reporting of etiologies of ST Elevation; cardiovascular mortality due to myocardial infarction, cardiac arrest and /or shock; individual components of the primary outcome; composite primary outcome at 1 year; as well as ECG and angiographic characteristics. Conclusion: The multicenter NACMI registry will collect data regarding ST elevation on ECG in COVID-19 patients to determine the etiology and associated clinical outcomes. The collaboration and speed with which this registry has been created, refined, and promoted serves as a template for future research endeavors.

Can percutaneous coronary interventions be performed safely in leukemia patients?

Patients with leukemia are often denied percutaneous coronary intervention (PCI), and those who do undergo PCI are older and sicker. There is a minor increase in vascular complications and no increase in retroperitoneal bleeds, suggesting transfusions may be given for reasons unrelated to the PCI. Since cardiac complications are not increased in leukemia patients, the increased mortality observed in after PCI in acute leukemia may be related more to underlying malignancy.

Does the method of administering fluids matter for contrast-induced nephropathy? REMEDIAL III compares LVEDP versus urine flow-guided hydration.

Contrast-induced nephropathy (CIN) is a major cause of morbidity and mortality among patients undergoing angiographic procedures. Limiting contrast dose and administration of intravenous normal saline appear to be the best approaches to reducing CIN, but the timing, dose, and duration of optimal hydration is poorly understood. The REMEDIAL III trial protocol outlines two different targeted hydration regimens (guided either by continuous measurement of urine output or by initial left ventricular end diastolic pressure (LVEDP), and 700 patients at high risk of CIN will be randomized.

Invasive imaging of myocardial infarction patients: Is less or more better?

Advanced intravascular imaging or fractional flow reserve in acute myocardial infarction patients may be safely performed and may be associated with clinical benefits. Since this is a nonrandomized registry with too few numbers to adequately evaluate mortality, it is uncertain whether clinical outcomes are truly improved. Adequately powered randomized trials using advanced imaging versus angiographic guided percutaneous coronary intervention (PCI) would be helpful.

STEMI in the cancer patient: Do not withhold primary PCI!

Poor outcomes observed in cancer patients who sustain STEMI are due, in part, to advanced age, comorbidities, and underutilization of guidelines-based therapies. Coronary angiography in the cancer patient is more likely to demonstrate MINOCA, but the majority have critical disease and PCI success is similar to noncancer patients. We recommend primary PCI with stenting as the default strategy in STEMI patients with cancer.

Outcomes of nonemergent percutaneous coronary intervention requiring mechanical circulatory support in patients without cardiogenic shock.

BACKGROUND: The utilization of mechanical circulatory support (MCS) for percutaneous coronary intervention (PCI) using percutaneous ventricular assist device (PVAD) or intra-aortic balloon pump (IABP) has been increasing. We sought to evaluate the outcome of coronary intervention using PVAD compared with IABP in noncardiogenic shock and nonacute myocardial infarction patients. METHOD: Using the National Inpatient Sampling (NIS) database from 2005 to 2014, we identified patients who underwent PCI using ICD 9 codes. Patients with cardiogenic shock, acute coronary syndrome, or acute myocardial infarction were excluded. Patient was stratified based on the MCS used, either to PVAD or IABP. Univariate and multivariate logistic regression were performed to study PCI outcome using PVAD compared with IABP. RESULTS: Out of 21,848 patients who underwent PCI requiring MCS, 17,270 (79.0%) patients received IABP and 4,578 (21%) patients received PVAD. PVAD patients were older (69 vs. 67, p < .001), were less likely to be women (23.3% vs. 33.3%, p < .001), and had higher rates of hypertension, diabetes, hyperlipidemia prior PCI, prior coronary artery bypass graft surgery, anemia, chronic lung disease, liver disease, renal failure, and peripheral vascular disease compared with IABP group (p ≤ .007). Using Multivariate logistic regression, PVAD patients had lower in-hospital mortality (6.1% vs. 8.8%, adjusted odds ratio [aOR] 0.62; 95% CI 0.51, 0.77, p < .001), vascular complications (4.3% vs. 7.5%, aOR 0.78; 95% CI 0.62, 0.99, p = .046), cardiac complications (5.6% vs. 14.5%, aOR 0.29; 95% CI 0.24, 0.36, p < .001), and respiratory complications (3.8% vs. 9.8%, aOR 0.37; 95% CI 0.28, 0.48, p < .001) compared with patients who received IABP. CONCLUSION: Despite higher comorbidities, nonemergent PCI procedures using PVAD were associated with lower mortality compared with IABP.

Sex-related difference in the use of percutaneous left ventricular assist device in patients undergoing complex high-risk percutaneous coronary intervention: Insight from the cVAD registry.

OBJECTIVE: To assess the in-hospital and short-term outcome differences between males and females who underwent high-risk PCI with mechanical circulatory support (MCS). BACKGROUND: Sex differences have been noted in several percutaneous coronary intervention (PCI) series with females less likely to be referred for PCI due increased risk of adverse events. However, data on sex differences in utilization and outcomes of high-risk PCI with MCS is scarce. METHODS: Using the cVAD Registry, we identified 1,053 high-risk patients who underwent PCI with MCS using Impella 2.5 or Impella CP. Patients with cardiogenic shock were excluded. A total of 792 (75.21%) males and 261 (24.79%) females were included in the analysis with median follow-up of 81.5 days. RESULTS: Females were more likely to be African American, older (72.05 ± 11.66 vs. 68.87 ± 11.17, p < .001), have a higher prevalence of diabetes (59.30 vs. 49.04%, p = .005), renal insufficiency (35.41 vs. 27.39%, p = .018), and peripheral vascular disease (31.89 vs. 25.39%, p of .05). Women had a higher mean STS score (8.21 ± 8.21 vs. 5.04 ± 5.97, p < .001) and lower cardiac output on presentation (3.64 ± 1.30 vs. 4.63 ± 1.49, p < .001). Although women had more comorbidities, there was no difference in in-hospital mortality, stroke, MI or need for recurrent revascularization compared to males. Females were more likely to have multivessel revascularization than males. Ejection fraction improved in both males and females at the time of discharge (26.59 to 31.40% and 30.75 to 36.05%, respectively, p < .0001). However, females had higher rate of bleeding requiring transfusion compared with males (9.58 vs. 5.30%, p = .019). CONCLUSION: Female patients undergoing high PCI were older and had more comorbidities but had similar outcomes compared to males.

Hot topics in interventional cardiology: Proceedings from the society for cardiovascular angiography and interventions 2020 think tank.

The society for cardiovascular angiography and interventions (SCAI) think tank is a collaborative venture that brings together interventional cardiologists, administrative partners, and select members of the cardiovascular industry community for high-level field-wide discussions. The 2020 think tank was organized into four parallel sessions reflective of the field of interventional cardiology: (a) coronary intervention, (b) endovascular medicine, (c) structural heart disease, and (d) congenital heart disease (CHD). Each session was moderated by a senior content expert and co-moderated by a member of SCAI's emerging leader mentorship program. This document presents the proceedings to the wider cardiovascular community in order to enhance participation in this discussion, create additional dialogue from a broader base, and thereby aid SCAI and the industry community in developing specific action items to move these areas forward.