Publications by authors named "Venu Menon"

209 Publications

The Range of Cardiogenic Shock Survival by Clinical Stage: Data From the Critical Care Cardiology Trials Network Registry.

Crit Care Med 2021 Apr 2. Epub 2021 Apr 2.

1 Peter Munk Cardiac Centre, University Health Network, Toronto, ON, Canada. 2 Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada. 3 Ted Rogers Centre for Heart Research, Toronto, ON, Canada. 4 Levine Cardiac Intensive Care Unit, TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA. 5 Division of Cardiovascular Medicine, Duke University, Durham, NC. 6 Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN. 7 Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC. 8 Department of Cardiology, St. Vincent Hospital, Indianapolis, IN. 9 Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Mayo Clinic, Rochester, MN. 10 Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH. 11 John Hopkins University, Baltimore, MD. 12 Division of Cardiovascular Medicine, University of Utah School of Medicine, Salt Lake City, UT. 13 University of California San Diego, San Diego, CA. 14 Inova Heart and Vascular Institute, Inova Fairfax Medical Center, Falls Church, VA. 15 Department of Medicine, Stanford University School of Medicine, Stanford, CA. 16 Departments of Critical Care and Medicine (Cardiology), University of Alberta, Edmonton, AB, Canada.

Objectives: Cardiogenic shock presents with variable severity. Categorizing cardiogenic shock into clinical stages may improve risk stratification and patient selection for therapies. We sought to determine whether a structured implementation of the 2019 Society for Cardiovascular Angiography and Interventions clinical cardiogenic shock staging criteria that is ascertainable in clinical registries discriminates mortality in a contemporary population with or at-risk for cardiogenic shock.

Design: We developed a pragmatic application of the Society for Cardiovascular Angiography and Interventions cardiogenic shock staging criteria-A (at-risk), B (beginning), C (classic cardiogenic shock), D (deteriorating), or E (extremis)-and examined outcomes by stage.

Setting: The Critical Care Cardiology Trials Network is an investigator-initiated multicenter research collaboration coordinated by the TIMI Study Group (Boston, MA). Consecutive admissions with or at-risk for cardiogenic shock during two annual 2-month collection periods (2017-2019) were analyzed.

Patients: Patients with or at-risk for cardiogenic shock.

Measurements And Main Results: Of 8,240 CICU admissions reviewed, 1,991 (24%) had or were at-risk for cardiogenic shock. Distributions across the five stages were as follows: A: 33%; B: 7%; C: 16%; D: 23%; and E: 21%. Overall in-hospital mortality among patients with established cardiogenic shock was 39%; however, mortality varied from only 15.8% to 32.1% to 62.5% across stages C, D, and E (Cochran-Armitage ptrend < 0.0001). The Society for Cardiovascular Angiography and Interventions stages improved mortality prediction beyond the Sequential Organ Failure Assessment and Intra-Aortic Balloon Pumpin Cardiogenic Shock II scores.

Conclusions: Although overall mortality in cardiogenic shock remains high, it varies considerably based on clinical stage, identifying stage C as relatively lower risk. We demonstrate a pragmatic adaptation of the Society for Cardiovascular Angiography and Interventions cardiogenic shock stages that effectively stratifies mortality risk and could be leveraged for future clinical research.
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http://dx.doi.org/10.1097/CCM.0000000000004948DOI Listing
April 2021

Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Rheumatic Aortic Stenosis.

J Am Coll Cardiol 2021 Apr;77(14):1703-1713

Department of Internal Medicine, University of Iowa Carver College of Medicine, Iowa City, Iowa, USA; Comprehensive Access and Delivery Research and Evaluation Center (CADRE), VA Medical Center, Iowa City, Iowa, USA.

Background: Patients with rheumatic aortic stenosis (AS) were excluded from transcatheter aortic valve replacement (TAVR) trials.

Objectives: The authors sought to examine outcomes with TAVR versus surgical aortic valve replacement (SAVR) in patients with rheumatic AS, and versus TAVR in nonrheumatic AS.

Methods: The authors identified Medicare beneficiaries who underwent TAVR or SAVR from October 2015 to December 2017, and then identified patients with rheumatic AS using prior validated International Classification of Diseases, Version 10 codes. Overlap propensity score weighting analysis was used to adjust for measured confounders. The primary study outcome was all-cause mortality. Multiple secondary outcomes were also examined.

Results: The final study cohort included 1,159 patients with rheumatic AS who underwent aortic valve replacement (SAVR, n = 554; TAVR, n = 605), and 88,554 patients with nonrheumatic AS who underwent TAVR. Patients in the SAVR group were younger and with lower prevalence of most comorbidities and frailty scores. After median follow-up of 19 months (interquartile range: 13 to 26 months), there was no difference in all-cause mortality with TAVR versus SAVR (11.2 vs. 7.0 per 100 person-year; adjusted hazard ratio: 1.53; 95% confidence interval: 0.84 to 2.79; p = 0.2). Compared with TAVR in nonrheumatic AS, TAVR for rheumatic AS was associated with similar mortality (15.2 vs. 17.7 deaths per 100 person-years (adjusted hazard ratio: 0.87; 95% confidence interval: 0.68 to 1.09; p = 0.2) after median follow-up of 17 months (interquartile range: 11 to 24 months). None of the rheumatic TAVR patients, <11 SAVR patients, and 242 nonrheumatic TAVR patients underwent repeat aortic valve replacement (124 redo-TAVR and 118 SAVR) at follow-up.

Conclusions: Compared with SAVR, TAVR could represent a viable and possibly durable option for patients with rheumatic AS.
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http://dx.doi.org/10.1016/j.jacc.2021.02.032DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8043573PMC
April 2021

Implementation of a Myocardial Perfusion Imaging Risk Algorithm to Inform Appropriate Downstream Invasive Testing and Treatment.

Circ Cardiovasc Imaging 2021 Mar 26:CIRCIMAGING120011984. Epub 2021 Mar 26.

Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic Foundation, OH.

Background: To risk stratify patients undergoing single-photon emission computed tomography myocardial perfusion imaging (SPECT-MPI) in accordance with appropriate use criteria for referral to coronary angiography, we developed a risk classification algorithm incorporating appropriate use criteria-defined risk features. We evaluated the association between this algorithm with downstream angiography, revascularization, and all-cause mortality.

Methods: We studied consecutive patients who underwent SPECT-MPI from January 1, 2015, to December 31, 2017, and assigned a scan risk of low, intermediate, high, or indeterminate. With this stratification, we assessed referral for angiography and revascularization within 3 months of SPECT-MPI and intermediate-term mortality.

Results: Among 12 799 patients, the mean age was 66 years, and a majority were men (56.8%). Most patients were low risk (83.6%) followed by intermediate (9.9%) and high risk (5.2%). Compared with low-risk patients, intermediate- and high-risk patients were more frequently referred for angiography (14.8% and 13.6% versus 2.0%; <0.001) and revascularization (7.7% and 6.8% versus 0.7%; <0.001). In 1008 propensity-matched patients, scan risk was independently associated with angiography after adjustment for ischemia, scar, or stress ejection fraction. At a mean follow-up of 2.3 years, mortality was higher with increased scan risk (high, 10.4%; intermediate, 7.1%; low, 4.1%; <0.001). Compared with low scan risk, intermediate (hazard ratio, 1.37 [95% CI, 1.09-1.72]; =0.008) and high scan risk (hazard ratio, 1.98 [95% CI, 1.53-2.56]; <0.001) were associated with mortality in multivariable analysis. Similar findings were observed for those undergoing pharmacological and exercise SPECT-MPI with comparatively worse prognosis among pharmacological patients.

Conclusions: This appropriate use criteria-derived risk classification algorithm for SPECT-MPI guided referral for coronary angiography and revascularization and was significantly associated with mortality. This algorithm may serve as an important tool to reaffirm appropriate use criteria and direct management of patients with stable ischemic heart disease undergoing stress testing.
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http://dx.doi.org/10.1161/CIRCIMAGING.120.011984DOI Listing
March 2021

Invasive Management of Acute Myocardial Infarction Complicated by Cardiogenic Shock: A Scientific Statement From the American Heart Association.

Circulation 2021 Apr 4;143(15):e815-e829. Epub 2021 Mar 4.

Cardiogenic shock (CS) remains the most common cause of mortality in patients with acute myocardial infarction. The SHOCK trial (Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock) demonstrated a survival benefit with early revascularization in patients with CS complicating acute myocardial infarction (AMICS) 20 years ago. After an initial improvement in mortality related to revascularization, mortality rates have plateaued. A recent Society of Coronary Angiography and Interventions classification scheme was developed to address the wide range of CS presentations. In addition, a recent scientific statement from the American Heart Association recommended the development of CS centers using standardized protocols for diagnosis and management of CS, including mechanical circulatory support devices (MCS). A number of CS programs have implemented various protocols for treating patients with AMICS, including the use of MCS, and have published promising results using such protocols. Despite this, practice patterns in the cardiac catheterization laboratory vary across health systems, and there are inconsistencies in the use or timing of MCS for AMICS. Furthermore, mortality benefit from MCS devices in AMICS has yet to be established in randomized clinical trials. In this article, we outline the best practices for the contemporary interventional management of AMICS, including coronary revascularization, the use of MCS, and special considerations such as the treatment of patients with AMICS with cardiac arrest.
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http://dx.doi.org/10.1161/CIR.0000000000000959DOI Listing
April 2021

Dynamic Assessment of Pulmonary Artery Pulsatility Index Provides Incremental Risk Assessment for Early Right Ventricular Failure After Left Ventricular Assist Device.

J Card Fail 2021 Feb 25. Epub 2021 Feb 25.

Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio; Department of Cardiology, Mater Misericordiae University Hospital, Dublin, Ireland.

Background: The pulmonary artery pulsatility index (PAPi) has been studied to predict right ventricular failure (RVF) after left ventricular assist device (LVAD) implantation, but only as a single time point before LVAD implantation. Multiple clinical factors and therapies impact RV function in pre-LVAD patients. Thus, we hypothesized that serial PAPi measurements during cardiac intensive care unit (CICU) optimization before LVAD implantation would provide incremental risk stratification for early RVF after LVAD implantation.

Methods And Results: Consecutive patients who underwent sequential pulmonary artery catherization with cardiac intensive care optimization before durable LVAD implantation were included. Serial hemodynamics were reviewed retrospectively across the optimization period. The optimal PAPi was defined by the initial PAPi + the PAPi at optimized hemodynamics. RVF was defined as need for a right ventricular assist device or prolonged inotrope use (>14 days postoperatively). Patients with early RVF had significantly lower mean optimal PAPi (3.5 vs 7.5, P < .001) compared with those who did not develop RVF. After adjusting for established risk factors of early RVF after LVAD implantation, the optimal PAPi was independently and incrementally associated with early RVF after LVAD implantation (odds ratio 0.64, 95% confidence interval 0.532-0.765, P < .0001).

Conclusions: Optimal PAPi achieved during medical optimization before LVAD implantation provides independent and incremental risk stratification for early RVF, likely identifying dynamic RV reserve.
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http://dx.doi.org/10.1016/j.cardfail.2021.02.012DOI Listing
February 2021

Post-Myocardial Infarction Ventricular Septal Rupture Bridged to Heartmate 3 with an Impella 5.5.

Ann Thorac Surg 2021 Jan 19. Epub 2021 Jan 19.

Department of Thoracic and Cardiovascular Surgery, Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, OH. Electronic address:

Optimal timing of surgical repair for patients diagnosed with a post-myocardial infarction ventricular septal rupture (post-MI VSR) is controversial. Urgent surgical intervention to prevent hemodynamic decompensation must be balanced against delayed repair to allow for tissue stabilization and increased likelihood of a successful outcome. We report the use of an axillary Impella 5.5 temporary left ventricular assist device to aid in hemodynamic stabilization, shunt fraction reduction, and tissue maturation with eventual definitive surgical repair in a patient that presented with a post-MI VSR and cardiogenic shock.
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http://dx.doi.org/10.1016/j.athoracsur.2020.12.044DOI Listing
January 2021

Defining Shock and Preshock for Mortality Risk Stratification in Cardiac Intensive Care Unit Patients.

Circ Heart Fail 2021 Jan 19;14(1):e007678. Epub 2021 Jan 19.

Sentara Heart Hospital, Advanced Heart Failure Center and Eastern Virginia Medical School, Norfolk, Virginia (D.A.B.).

Background: Previous studies have defined preshock as isolated hypotension or isolated hypoperfusion, whereas shock has been variably defined as hypoperfusion with or without hypotension. We aimed to evaluate the mortality risk associated with hypotension and hypoperfusion at the time of admission in a cardiac intensive care unit population.

Methods: We analyzed Mayo Clinic cardiac intensive care unit patients admitted between 2007 and 2015. Hypotension was defined as systolic blood pressure <90 mm Hg or mean arterial pressure <60 mm Hg, and hypoperfusion as admission lactate >2 mmol/L, oliguria, or rising creatinine. Associations between hypotension and hypoperfusion with hospital mortality were estimated using multivariable logistic regression.

Results: Among 10 004 patients with a median age of 69 years, 43.1% had acute coronary syndrome, and 46.1% had heart failure. Isolated hypotension was present in 16.7%, isolated hypoperfusion in 15.3%, and 8.7% had both hypotension and hypoperfusion. Stepwise increases in hospital mortality were observed with hypotension and hypoperfusion compared with neither hypotension nor hypoperfusion (3.3%; all <0.001): isolated hypotension, 9.3% (adjusted odds ratio, 1.7 [95% CI, 1.4-2.2]); isolated hypoperfusion, 17.2% (adjusted odds ratio, 2.3 [95% CI, 1.9-3.0]); both hypotension and hypoperfusion, 33.8% (adjusted odds ratio, 2.8 [95% CI, 2.1-3.6]). Adjusted hospital mortality in patients with isolated hypoperfusion was higher than in patients with isolated hypotension (=0.02) and not significant different from patients with both hypotension and hypoperfusion (=0.18).

Conclusions: Hypotension and hypoperfusion are both associated with increased mortality in cardiac intensive care unit patients. Hospital mortality is higher with isolated hypoperfusion or concomitant hypotension and hypoperfusion (classic shock). We contend that preshock should refer to isolated hypotension without hypoperfusion, while patients with hypoperfusion can be considered to have shock, irrespective of blood pressure.
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http://dx.doi.org/10.1161/CIRCHEARTFAILURE.120.007678DOI Listing
January 2021

Ineffective Perfusion: An Ominous Sign No Matter How You Measure It.

Authors:
Venu Menon

JACC Cardiovasc Imaging 2021 Feb 13;14(2):333-334. Epub 2021 Jan 13.

Cleveland Clinic Lerner College of Medicine, Cleveland Clinic, Cleveland, Ohio, USA. Electronic address:

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http://dx.doi.org/10.1016/j.jcmg.2020.12.003DOI Listing
February 2021

Acute Hemodynamic Effects of Sacubitril-Valsartan In Heart Failure Patients Receiving Intravenous Vasodilator and Inotropic Therapy.

J Card Fail 2021 Mar 16;27(3):368-372. Epub 2021 Jan 16.

Robert and Suzanne Tomsich Department of Cardiovascular Medicine, Sydell and Arnold Miller Family Heart and Vascular Institute, George M. and Linda H. Kaufman Center for Heart Failure and Recovery, Cleveland Clinic, Cleveland, Ohio. Electronic address:

Background: Prior study has demonstrated that transitioning patients in acutely decompensated heart failure with a low cardiac output directly from intravenous (i.v.) vasoactive (ie, vasodilators or inotropes) drugs to sacubitril-valsartan (S/V) can be done safely with tolerance to the 1-month follow-up. Here, we further characterize the hemodynamic impact of S/V after patients have been optimized on vasoactive therapy.

Methods And Results: In a single-center, retrospective analysis, 25 patients with cardiac index of less than 2.2 L/min/m were admitted to the cardiac intensive care unit and newly initiated on angiotensin receptor-neprilysin inhibitor therapy with the guidance of invasive hemodynamic monitoring. Hemodynamic data were gathered and compared upon cardiac intensive care unit admission, after optimization with i.v. vasoactive therapy, and after S/V initiation and weaning off i.v.

Therapy: All patients who tolerated S/V (n = 20) were weaned off vasoactive medications before transfer out of cardiac intensive care unit. Patients maintained their significant improvement in cardiac index and reduction in SVR/PVR on transition from i.v. inotropic and vasodilator therapy to oral S/V. There was an increase in pulmonary artery pulsatility index with S/V therapy compared with the i.v. vasoactive phase of care.

Conclusions: Patients in the cardiac intensive care unit can be successfully bridged from vasoactive i.v. therapy to oral S/V with sustained improvement in cardiac index garnered from vasoactive agents. We also observed improvement in the pulmonary artery pulsatility index and maintenance of left and right ventricular unloading with S/V. These encouraging findings merit further prospective study.
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http://dx.doi.org/10.1016/j.cardfail.2020.12.013DOI Listing
March 2021

Systemic Inflammatory Response Syndrome Is Associated With Increased Mortality Across the Spectrum of Shock Severity in Cardiac Intensive Care Patients.

Circ Cardiovasc Qual Outcomes 2020 12 7;13(12):e006956. Epub 2020 Dec 7.

Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine (J.C.J., K.B.K.), Mayo Clinic, Rochester, MN.

Background: The systemic inflammatory response syndrome (SIRS) frequently occurs in patients with cardiogenic shock and may aggravate shock severity and organ failure. We sought to determine the association of SIRS with illness severity and survival across the spectrum of shock severity in cardiac intensive care unit (CICU) patients.

Methods: We retrospectively analyzed 8995 unique patients admitted to the Mayo Clinic CICU between 2007 and 2015. Patients with ≥2/4 SIRS criteria based on admission laboratory and vital sign data were considered to have SIRS. Patients were stratified by the 2019 Society for Cardiovascular Angiography and Interventions (SCAI) shock stages using admission data. The association between SIRS and mortality was evaluated across SCAI shock stage using logistic regression and Cox proportional-hazards models for hospital and 1-year mortality, respectively.

Results: The study population had a mean age of 67.5±15.2 years, including 37.2% women. SIRS was present in 33.9% of patients upon CICU admission and was more prevalent in advanced SCAI shock stages. Patients with SIRS had higher illness severity, worse shock, and more organ failure, with an increased risk of mortality during hospitalization (16.8% versus 3.8%; adjusted odds ratio, 2.1 [95% CI, 1.7-2.5]; <0.001) and at 1 year (adjusted hazard ratio, 1.4 [95% CI, 1.3-1.6]; <0.001). After multivariable adjustment, SIRS was associated with higher hospital and 1-year mortality among patients in SCAI shock stages A through D (all <0.01) but not SCAI shock stage E.

Conclusions: One-third of CICU patients meet clinical criteria for SIRS at the time of admission, and these patients have higher illness severity and worse outcomes across the spectrum of SCAI shock stages. The presence of SIRS identified CICU patients at increased risk of short-term and long-term mortality. Further study is needed to determine whether systemic inflammation truly drives SIRS in this population and whether patients with SIRS respond differently to supportive therapies for shock.
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http://dx.doi.org/10.1161/CIRCOUTCOMES.120.006956DOI Listing
December 2020

Advanced Respiratory Support in the Contemporary Cardiac ICU.

Crit Care Explor 2020 Sep 17;2(9):e0182. Epub 2020 Sep 17.

TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.

The medical complexity and critical care needs of patients admitted to cardiac ICUs are increasing, and prospective studies examining the underlying cardiac and noncardiac diagnoses, the management strategies, and the prognosis of cardiac ICU patients with respiratory failure are needed.

Design: Prospective cohort study.

Setting: The Critical Care Cardiology Trials Network is a research collaborative of cardiac ICUs across the United States and Canada.

Patients: We included all medical cardiac ICU admissions at 25 cardiac ICUs during two consecutive months annually at each center from 2017 to 2019.

Measurements: We evaluated the use of advanced respiratory therapies including invasive mechanical ventilation, noninvasive ventilation, and high-flow nasal cannula versus no advanced respiratory support across admission diagnoses and the association with in-hospital mortality.

Main Results: Of 8,240 cardiac ICU admissions, 1,935 (23.5%) were treated with invasive mechanical ventilation, 573 (7.0%) with noninvasive ventilation, and 281 (3.4%) with high-flow nasal cannula. Admitting diagnoses among those with advanced respiratory support were diverse including general medical problems in patients with heart disease as well as primary cardiac problems. In-hospital mortality was higher in patients who received invasive mechanical ventilation (38.1%; adjusted odds ratio, 2.53; 2.02-3.16) and noninvasive ventilation or high-flow nasal cannula (8.8%; adjusted odds ratio, 2.25; 1.73-2.93) compared with patients without advanced respiratory support (4.6%). Reintubation rate was 7.6%. The most common variables associated with respiratory insufficiency included heart failure, infection, chronic obstructive pulmonary disease, and pulmonary vascular disease.

Conclusions: One-third of cardiac ICU admissions receive respiratory support with associated increased mortality. These data provide benchmarks for quality improvement ventures in the cardiac ICU, inform cardiac critical care training and staffing patterns, and serve as foundation for future studies aimed at improving outcomes.
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http://dx.doi.org/10.1097/CCE.0000000000000182DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7678799PMC
September 2020

Effect of High-Dose Omega-3 Fatty Acids vs Corn Oil on Major Adverse Cardiovascular Events in Patients at High Cardiovascular Risk: The STRENGTH Randomized Clinical Trial.

JAMA 2020 12;324(22):2268-2280

Cleveland Clinic Coordinating Center for Clinical Research, Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.

Importance: It remains uncertain whether the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) reduce cardiovascular risk.

Objective: To determine the effects on cardiovascular outcomes of a carboxylic acid formulation of EPA and DHA (omega-3 CA) with documented favorable effects on lipid and inflammatory markers in patients with atherogenic dyslipidemia and high cardiovascular risk.

Design, Setting, And Participants: A double-blind, randomized, multicenter trial (enrollment October 30, 2014, to June 14, 2017; study termination January 8, 2020; last patient visit May 14, 2020) comparing omega-3 CA with corn oil in statin-treated participants with high cardiovascular risk, hypertriglyceridemia, and low levels of high-density lipoprotein cholesterol (HDL-C). A total of 13 078 patients were randomized at 675 academic and community hospitals in 22 countries in North America, Europe, South America, Asia, Australia, New Zealand, and South Africa.

Interventions: Participants were randomized to receive 4 g/d of omega-3 CA (n = 6539) or corn oil, which was intended to serve as an inert comparator (n = 6539), in addition to usual background therapies, including statins.

Main Outcomes And Measures: The primary efficacy measure was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization.

Results: When 1384 patients had experienced a primary end point event (of a planned 1600 events), the trial was prematurely halted based on an interim analysis that indicated a low probability of clinical benefit of omega-3 CA vs the corn oil comparator. Among the 13 078 treated patients (mean [SD] age, 62.5 [9.0] years; 35% women; 70% with diabetes; median low-density lipoprotein [LDL] cholesterol level, 75.0 mg/dL; median triglycerides level, 240 mg/dL; median HDL-C level, 36 mg/dL; and median high-sensitivity C-reactive protein level, 2.1 mg/L), 12 633 (96.6%) completed the trial with ascertainment of primary end point status. The primary end point occurred in 785 patients (12.0%) treated with omega-3 CA vs 795 (12.2%) treated with corn oil (hazard ratio, 0.99 [95% CI, 0.90-1.09]; P = .84). A greater rate of gastrointestinal adverse events was observed in the omega-3 CA group (24.7%) compared with corn oil-treated patients (14.7%).

Conclusions And Relevance: Among statin-treated patients at high cardiovascular risk, the addition of omega-3 CA, compared with corn oil, to usual background therapies resulted in no significant difference in a composite outcome of major adverse cardiovascular events. These findings do not support use of this omega-3 fatty acid formulation to reduce major adverse cardiovascular events in high-risk patients.

Trial Registration: ClinicalTrials.gov Identifier: NCT02104817.
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http://dx.doi.org/10.1001/jama.2020.22258DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7667577PMC
December 2020

Clinical Characteristics and Outcomes of Non-ICU Hospitalization for COVID-19 in a Nonepicenter, Centrally Monitored Healthcare System.

J Hosp Med 2021 01;16(1):7-14

Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, Ohio.

Background: The clinical characteristics and outcomes associated with non-intensive care unit (non-ICU) hospitalizations for coronavirus disease 2019 (COVID-19) outside disease epicenters remain poorly characterized.

Methods: Systematic analysis of all non-ICU patient hospitalizations for COVID-19 completing discharge between March 13 and May 1, 2020, in a large US health care system utilizing off-site central monitoring. Variables of interest were examined in relation to a composite event rate of death, ICU transfer, or increased oxygen requirement to high-flow nasal cannula, noninvasive ventilation, or mechanical ventilation.

Results: Among 350 patients (age, 64 ± 16 years; 55% male), most (73%) required 3 L/min or less of supplemental oxygen during admission. Telemetry was widely utilized (79%) yet arrhythmias were uncommon (14%) and were predominantly (90%) among patients with abnormal troponin levels or known cardiovascular disease. Ventricular tachycardia was rare (5%), nonsustained, and not associated with hydroxychloroquine/azithromycin treatment. Adverse events occurred in 62 patients (18%), including 22 deaths (6%), 48 ICU transfers (14%), and 49 patients with increased oxygen requirement (14%) and were independently associated with elevated C-reactive protein (odds ratio, 1.09 per 1 mg/dL; 95% CI, 1.01-1.18; P = .04) and lactate dehydrogenase (OR, 1.006 per 1U/L; 95% CI, 1.001-1.012; P = .03) in multivariable analysis.

Conclusion: Among non-critically ill patients hospitalized within a nonepicenter health care system, overall survival was 94% with the development of more severe illness or death independently associated with higher levels of C-reactive protein and lactate dehydrogenase on admission. Clinical decompensation was largely respiratory-related, while serious cardiac arrhythmias were rare, which suggests that telemetry can be prioritized for high-risk patients.
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http://dx.doi.org/10.12788/jhm.3510DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7768915PMC
January 2021

Coronary Angiography in Patients With Out-of-Hospital Cardiac Arrest Without ST-Segment Elevation: A Systematic Review and Meta-Analysis.

JACC Cardiovasc Interv 2020 10;13(19):2193-2205

Heart and Vascular Institute, Department of Cardiology, Cleveland Clinic, Cleveland, Ohio. Electronic address:

Objectives: The authors conducted a meta-analysis to study clinical outcomes in patients who underwent early versus nonearly coronary angiography (CAG) in the setting of out-of-hospital cardiac arrest (OHCA) without ST-segment elevation.

Background: The benefit of performing early CAG in patients with OHCA without STE remains disputed.

Methods: MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials were searched according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines from inception until February 21, 2020. Early and nonearly CAG patients were identified on the basis of the definitions mentioned in respective published studies. The primary outcome studied was 30-day mortality. Secondary outcomes were neurological status and the rate of percutaneous coronary intervention (PCI) following cardiac arrest.

Results: Of 4,516 references, 11 studies enrolling 3,581 patients were included in the final meta-analysis. Random-effects analysis showed no differences in 30-day mortality (risk ratio [RR]: 0.86; 95% confidence interval [CI]: 0.71 to 1.04; p = 0.12; I = 74%), neurological status (RR: 1.08; 95% CI: 0.94 to 1.24; p = 0.28; I = 69%), and rate of PCI (RR: 1.22; 95% CI: 0.94 to 1.59; p = 0.13; I = 67%) between the 2 groups. Diabetes mellitus, chronic renal failure, previous PCI, and lactate level were found to be significant predictors of 30-day mortality on meta-regression (p < 0.05).

Conclusions: This analysis shows that there is no significant difference in 30-day mortality, neurological status, or rate of PCI among patients with OHCA without STE treated with early versus nonearly CAG. Thirty-day mortality is determined by presentation comorbidities rather than revascularization.
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http://dx.doi.org/10.1016/j.jcin.2020.07.018DOI Listing
October 2020

Implementation of a Comprehensive ST-Elevation Myocardial Infarction Protocol Improves Mortality Among Patients With ST-Elevation Myocardial Infarction and Cardiogenic Shock.

Am J Cardiol 2020 11 15;134:1-7. Epub 2020 Aug 15.

Heart and Vascular Institute, Cleveland Clinic Foundation, Cleveland, Ohio. Electronic address:

Mortality in patients with STEMI-associated cardiogenic shock (CS) is increasing. Whether a comprehensive ST-elevation myocardial infarction (STEMI) protocol (CSP) can improve their care delivery and mortality is unknown. We evaluated the impact of a CSP on incidence and outcomes in patients with STEMI-associated CS. We implemented a 4-step CSP including: (1) Emergency Department catheterization lab activation; (2) STEMI Safe Handoff Checklist; (3) immediate catheterization lab transfer; (4) and radial-first percutaneous coronary intervention (PCI). We studied 1,272 consecutive STEMI patients who underwent PCI and assessed for CS incidence per National Cardiovascular Data Registry definitions within 24-hours of PCI, care delivery, and mortality before (January 1, 2011, to July 14, 2014; n = 723) and after (July 15, 2014, to December 31, 2016; n = 549) CSP implementation. Following CSP implementation, CS incidence was reduced (13.0% vs 7.8%, p = 0.003). Of 137 CS patients, 43 (31.4%) were in the CSP group. CSP patients had greater IABP-Shock II risk scores (1.9 ± 1.8 vs 2.8 ± 2.2, p = 0.014) with otherwise similar hemodynamic and baseline characteristics, cardiac arrest incidence, and mechanical circulatory support use. Administration of guideline-directed medical therapy was similar (89.4% vs 97.7%, p = 0.172) with significant improvements in trans-radial PCI (9.6% vs 44.2%, p < 0.001) and door-to-balloon time (129.0 [89:160] vs 95.0 [81:116] minutes, p = 0.001) in the CSP group, translating to improvements in infarct size (CK-MB 220.9 ± 156.0 vs 151.5 ± 98.5 ng/ml, p = 0.005), ejection fraction (40.8 ± 14.5% vs 46.7 ± 14.6%, p = 0.037), and in-hospital mortality (30.9% vs 14.0%, p = 0.037). In conclusion, CSP implementation was associated with improvements in CS incidence, infarct size, ejection fraction, and in-hospital mortality in patients with STEMI-associated CS. This strategy offers a potential solution to bridging the historically elusive gap in their care.
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http://dx.doi.org/10.1016/j.amjcard.2020.08.012DOI Listing
November 2020

Canakinumab to reduce deterioration of cardiac and respiratory function in SARS-CoV-2 associated myocardial injury with heightened inflammation (canakinumab in Covid-19 cardiac injury: The three C study).

Clin Cardiol 2020 Oct 24;43(10):1055-1063. Epub 2020 Aug 24.

Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute Cleveland Clinic, Cleveland, Ohio, USA.

Background: In patients with Covid-19, myocardial injury and increased inflammation are associated with morbidity and mortality. We designed a proof-of-concept randomized controlled trial to evaluate whether treatment with canakinumab prevents progressive respiratory failure and worsening cardiac dysfunction in patients with SARS-CoV2 infection, myocardial injury, and high levels of inflammation.

Hypothesis: The primary hypothesis is that canakiumab will shorten time to recovery.

Methods: The three C study (canakinumab in Covid-19 Cardiac Injury, NCT04365153) is a double-blind, randomized controlled trial comparing canakinumab 300 mg IV, 600 mg IV, or placebo in a 1:1:1 ratio in hospitalized Covid-19 patients with elevations in troponin and C-reactive protein (CRP). The primary endpoint is defined as the time in days from randomization to either an improvement of two points on a seven category ordinal scale or discharge from the hospital, whichever occurs first up to 14 days postrandomization. The secondary endpoint is mortality at day 28. A total of 45 patients will be enrolled with an anticipated 5 month follow up period.

Results: Baseline characteristics for the first 20 randomized patients reveal a predominantly male (75%), elderly population (median 67 years) with a high prevalence of hypertension (80%) and hyperlipidemia (75%). CRPs have been markedly elevated (median 16.2 mg/dL) with modest elevations in high-sensitivity troponin T (median 21 ng/L), in keeping with the concept of enrolling patients with early myocardial injury.

Conclusions: The three C study will provide insights regarding whether IL-1β inhibition may improve outcomes in patients with SARS-CoV2 associated myocardial injury and increased inflammation.
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http://dx.doi.org/10.1002/clc.23451DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7461303PMC
October 2020

Targeting Mean Arterial Pressure to Limit Myocardial Injury: Novel Finding or Wild Goose Chase?

Authors:
Venu Menon

J Am Coll Cardiol 2020 08;76(7):825-827

Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio. Electronic address:

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http://dx.doi.org/10.1016/j.jacc.2020.06.054DOI Listing
August 2020

Characteristics and Outcomes of Patients With Takotsubo Syndrome: Incremental Prognostic Value of Baseline Left Ventricular Systolic Function.

J Am Heart Assoc 2020 08 5;9(16):e016537. Epub 2020 Aug 5.

Department of Cardiovascular Medicine Heart and Vascular Institute Cleveland Clinic Cleveland OH USA.

Background We sought to determine (1) long-term outcomes in patients presenting with documented Takotsubo syndrome (TS), (2) whether left ventricular global longitudinal strain (LV-GLS) provides incremental prognostic value, and (3) prognostic cutoffs of LV ejection fraction (LVEF) and LV-GLS during an acute TS episode. Methods and Results We studied 650 patients with TS (aged 66±14 years, 88% women) who were diagnosed clinically and angiographically between 2006 and 2018. Baseline LVEF and LV-GLS (using velocity vector imaging) were recorded. The primary end point was all-cause mortality. TS triggers were unknown (34%), emotional (16%), physical (41%), and neurologic (10%). Mean LVEF and LV-GLS were 36±10% and -11.6±0.4%; in addition, 94% patients had LVEF <52%, and 80% had apical ballooning. No patient had obstructive coronary artery disease. At a median of 2.2 years (interquartile range, 0.7-4.4), 175 (27%) had died (9% in-hospital deaths). Multivariate Cox survival analysis revealed that higher age (hazard ratio [HR], 1.35), male sex (HR, 1.75), lower baseline LVEF (HR, 1.02), worse LV-GLS (HR, 1.04), neurologic trigger (HR, 2.66), and physical trigger (HR, 2.64) were associated with mortality, whereas aspirin (HR, 0.70) and β-blockers (HR, 0.73) improved survival (all <0.049). The addition of LVEF and LV-GLS to clinical markers (age, sex, cardiogenic shock at presentation, and peak troponin I) significantly increased log-likelihood ratios: clinical (-521.48), clinical plus LVEF (-511.32, <0.001), and clinical plus LVEF and LV-GLS (-500.68, <0.001). On penalized spline analysis, LVEF of 38% and LV-GLS of -10% were cutoffs below which survival was significantly worse. Conclusions Patients with TS with a neurologic or physical trigger had significantly worse survival than those without such a trigger, with baseline LVEF and LV-GLS providing incremental prognostic value.
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http://dx.doi.org/10.1161/JAHA.120.016537DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7660826PMC
August 2020

Effect of C-Reactive Protein on Lipoprotein(a)-Associated Cardiovascular Risk in Optimally Treated Patients With High-Risk Vascular Disease: A Prespecified Secondary Analysis of the ACCELERATE Trial.

JAMA Cardiol 2020 Jul 8. Epub 2020 Jul 8.

MonashHeart, Department of Cardiology, Monash University, Clayton, Victoria, Australia.

Importance: Although lipoprotein(a) (Lp[a]) is a causal genetic risk factor for atherosclerotic cardiovascular disease, it remains unclear which patients with established atherosclerotic cardiovascular disease stand to benefit the most from Lp(a) lowering. Whether inflammation can modulate Lp(a)-associated cardiovascular (CV) risk during secondary prevention is unknown.

Objective: To examine whether Lp(a)-associated CV risk is modulated by systemic inflammation in optimally treated patients at high risk of CV disease.

Design, Setting, And Participants: A prespecified secondary post hoc analysis of the double-blind, multicenter randomized clinical Assessment of Clinical Effects of Cholesteryl Ester Transfer Protein Inhibition With Evacetrapib in Patients at a High Risk for Vascular Outcomes (ACCELERATE) trial was conducted between October 1, 2012, and December 31, 2013; the study was terminated October 12, 2015. The study was conducted at 543 academic and community hospitals in 36 countries among 12 092 patients at high risk of CV disease (acute coronary syndrome, stroke, peripheral arterial disease, or type 2 diabetes with coronary artery disease) with measurable Lp(a) and high-sensitivity C-reactive protein (hsCRP) levels during treatment. Statistical analysis for this post hoc analysis was performed from September 26, 2018, to March 28, 2020.

Interventions: Participants received evacetrapib, 130 mg/d, or matching placebo.

Main Outcomes And Measures: The ACCELERATE trial found no significant benefit or harm of evacetrapib on 30-month major adverse cardiovascular events (CV death, myocardial infarction [MI], stroke, coronary revascularization, or hospitalization for unstable angina). This secondary analysis evaluated rates of CV death, MI, and stroke across levels of Lp(a).

Results: High-sensitivity C-reactive protein and Lp(a) levels were measured in 10 503 patients (8135 men; 8561 white; 10 134 received concurrent statins; mean [SD] age, 64.6 [9.4] years). In fully adjusted analyses, in patients with hsCRP of 2 mg/L or more but not less than 2 mg/L, increasing quintiles of Lp(a) were significantly associated with greater rates of death, MI, and stroke (P = .006 for interaction). Each unit increase in log Lp(a) levels was associated with a 13% increased risk of CV death, nonfatal MI, or stroke only in those with hsCRP levels of 2 mg/L or more (P = .008 for interaction). There was also a significant stepwise relationship between increasing Lp(a) quintiles and time to first CV death, MI, or stroke (log-rank P < .001) when hsCRP levels were 2 mg/L or more but not less than 2 mg/L. Sensitivity analyses in the ACCELERATE placebo-treated group yielded similar significant associations exclusively in the group with hsCRP of 2 mg/L or more.

Conclusions And Relevance: Elevated Lp(a) levels during treatment are related to CV death, MI, and stroke when hsCRP levels are 2 mg/L or more but not less than 2mg/L. This finding suggests a potential benefit of lowering Lp(a) in patients with residual systemic inflammation despite receipt of optimal medical therapy.

Trial Registration: ClinicalTrials.gov Identifier: NCT01687998.
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http://dx.doi.org/10.1001/jamacardio.2020.2413DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7344788PMC
July 2020

Prognostic Value of Functional Capacity in Different Exercise Protocols.

J Am Heart Assoc 2020 07 24;9(13):e015986. Epub 2020 Jun 24.

Heart and Vascular Institute Cleveland Clinic Cleveland OH.

Background Functional capacity is associated with mortality, although the prognostic value of achieved estimated metabolic equivalents (METs) across various exercise protocols is not established. We sought to determine whether achieved METs had different prognostic implications according to the protocol employed. Methods and Results From 1991 to 2015, we identified 120 705 consecutive patients from a stress testing registry who underwent the following 7 different standardized exercise protocols: Bruce, modified Bruce, Cornell 0%, Cornell 5%, Cornell 10%, Naughton, and modified Naughton. The primary outcome was all-cause mortality. There were 74 953 Bruce, 8368 modified Bruce, 2648 Cornell 0%, 9972 Cornell 5%, 20 425 Cornell 10%, 1226 Naughton, and 3113 modified Naughton protocols. During a mean follow-up of 8.7 years, a total of 8426 deaths (6.9%) occurred. When compared with the Bruce protocol, after multivariable adjustment for clinical risk factors, medications, and functional capacity, test protocol was independently associated with mortality (modified Naughton [hazard ratio (HR), 2.51; 95% CI, 2.26-2.8], Naughton [HR, 1.79; 95% CI, 1.57-2.04], Cornell 0% [HR, 1.79; 95% CI, 1.59-2.01], modified Bruce [HR, 1.62; 95% CI, 1.48-1.76], Cornell 5% [HR, 1.61; 95% CI, 1.47-1.75], and Cornell 10% [HR, 1.32; 95% CI, 1.22-1.42]). Across all protocols, higher estimated METs were associated with lower mortality, although the equivalent METs achieved were associated with a worse prognosis in less-demanding protocols. Conclusions Higher estimated METs are reliably associated with lower mortality in all exercise protocols, although the prognostic value is not transferable across different tests. Consequently, the prognostic value of METs achieved during a stress test should be considered protocol dependent.
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http://dx.doi.org/10.1161/JAHA.119.015986DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7670526PMC
July 2020

Initial experience regarding the safety and yield of rest-stress myocardial perfusion imaging in emergency department patients with mildly abnormal high-sensitivity cardiac troponins.

J Nucl Cardiol 2020 Jun 17. Epub 2020 Jun 17.

Department of Cardiovascular Imaging, Heart and Vascular Institute, Cleveland Clinic, Cleveland, OH, USA.

Background: With high-sensitivity troponin testing, approximately a third of patients presenting to emergency departments (EDs) with suspected acute coronary syndromes will have mildly abnormal values. However, data regarding rest-stress myocardial perfusion imaging (MPI) in these patients are limited. We hypothesize that stress testing is safe and that the yield for detecting myocardial ischemia is associated with risk stratification by the HEART score.

Methods And Results: We conducted a retrospective cohort study of consecutive patients referred for rest-stress MPI with mildly abnormal high-sensitivity troponin T (hs-cTn) values. Outcomes were adverse events related to stress MPI, defined as myocardial infarction or ventricular tachyarrhythmia, and the presence of ischemia, defined as a reversible perfusion defect. Among 213 patients, the median age was 67, most were male (61.5%, n = 131), and prior CAD was common (53.5%, n = 114). Myocardial ischemia was present in 13.6% (n = 29), and there were no adverse events attributable to stress MPI. A higher HEART score was associated with myocardial ischemia (Odds Ratio [OR] 1.50, 95% Confidence Interval [CI] 1.08 to 2.08, P = .002).

Conclusion: Rest-stress MPI appears safe in patients with mildly abnormal hs-cTn values, and the yield for detecting ischemia is associated with the HEART score, though further validation studies are needed.
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http://dx.doi.org/10.1007/s12350-020-02145-wDOI Listing
June 2020

Impact of tricuspid regurgitation on postoperative outcomes after non-cardiac surgeries.

Open Heart 2020 21;7(1):e001183. Epub 2020 Apr 21.

Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic Foundation, Cleveland, Ohio, USA.

Objective: Tricuspid regurgitation (TR) severity has known adverse implications, its impact on patients undergoing non-cardiac surgery (NCS) remains unclear. We sought to determine the impact of TR on patient outcomes after NCS.

Methods: We performed a retrospective cohort study in patients undergoing NCS. Outcomes in patients with moderate or severe TR were compared with no/trivial TR after adjusting for baseline characteristics and revised cardiac risk index (RCRI). The primary outcome was defined as 30-day mortality and heart failure (HF), while the secondary outcome was long-term mortality.

Results: Of the 7064 patients included, 312 and 80 patients had moderate and severe TR, respectively. Thirty-day mortality was higher in moderate TR (adjusted OR 2.44, 95% CI 1.25 to 4.76) and severe TR (OR 2.85, 95% CI 1.04 to 7.79) compared with no/trivial TR. There was no difference in 30-day HF in patients with moderate TR (OR 1.48, 95% CI 0.90 to 2.44) or severe TR (OR 1.42, 95% CI 0.60 to 3.39). The adjusted HR for long-term mortality in moderate TR was 1.55 (95% CI 1.31 to 1.82) and 1.87 (95% CI 1.40 to 2.50) for severe TR compared with no/trivial TR.

Conclusion: Increasing TR severity has higher postoperative 30-day mortality in patients undergoing NCS, independent of RCRI risk factors, ejection fraction or mitral regurgitation. Severity of TR should be considered in risk stratification for patients undergoing NCS.
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http://dx.doi.org/10.1136/openhrt-2019-001183DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7204555PMC
December 2020

Influence of cardiac arrest and SCAI shock stage on cardiac intensive care unit mortality.

Catheter Cardiovasc Interv 2020 Dec 17;96(7):1350-1359. Epub 2020 Mar 17.

Department of Critical Care Medicine and Division of Cardiology, Department of Medicine, University of Alberta Hospital, Edmonton, Alberta, Canada.

Background: Patients with concomitant cardiac arrest (CA) and shock are at increased risk of mortality, even when stratified according to shock severity. We sought to determine whether the presence of ventricular fibrillation (VF) modified the relationship between CA and mortality in cardiac intensive care unit (CICU) patients.

Methods: We retrospectively analyzed unique Mayo Clinic CICU patients admitted between 2007 and 2015. Society for Cardiovascular Angiography and Intervention (SCAI) shock stages A through E were classified at admission. Hospital mortality in each SCAI shock stage was stratified by the presence of CA, VF CA, or non-VF CA.

Results: We included 9,898 patients with a mean age of 68 years (38% females). CA was present in 12%, including 53% with VF CA and 47% with non-VF CA. Hospital mortality was higher in patients with CA compared to patients without CA (34% vs. 6%; adjusted odds ratio [OR] = 3.1, 95% CI [2.4, 4.0], p < .001), and patients with non-VF CA had higher hospital mortality than patients with VF CA (44% vs. 25%; adjusted OR = 2.1, 95% CI [1.4, 3.0], p < .001). After adjustment, patients with any CA or non-VF CA had higher hospital mortality at each SCAI stage, except stage E (all other p < .05), whereas patients with VF CA did not (all p > .1).

Conclusions: CA rhythm modifies the relationship between CA and mortality in CICU patients, when accounting for coma, shock, and organ failure. Outcome studies examining CA in patients with cardiogenic shock need to account for important differences such as CA rhythm.
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http://dx.doi.org/10.1002/ccd.28854DOI Listing
December 2020

Effect of CETP inhibition with evacetrapib in patients with diabetes mellitus enrolled in the ACCELERATE trial.

BMJ Open Diabetes Res Care 2020 03;8(1)

Heart and Vascular Institute, Cleveland Clinic Foundation, Cleveland, Ohio, USA.

Background: High-density lipoprotein (HDL) levels are inversely associated with cardiovascular risk. Cholesteryl ester transfer protein inhibition with evacetrapib results in a marked increase in HDL and reduction in low-density lipoprotein (LDL) levels. We evaluated the impact of treatment with evacetrapib versus placebo in the subset of 8236 patients with diabetes mellitus (DM) enrolled in the Assessment of Clinical Effects of Cholesteryl Ester Transfer Protein Inhibition with Evacetrapib in Patients at a High Risk for Vascular Outcomes trial.

Methods And Results: Time to first occurrence of any component of the primary composite endpoint of cardiovascular death, myocardial infarction, stroke, revascularization, and hospitalization for unstable angina was compared among patients with DM randomized to treatment with evacetrapib (n=4127) or placebo (n=4109) over a median of 26 months of follow-up. The mean baseline LDL at initiation was 80 mg/dL with a mean baseline HDL of 44 mg/dL. In patients with DM, evacetrapib resulted in a 131% mean increase in HDL levels and a 32% mean decrease in LDL at 3 months that was sustained during the course of the trial. At 6 months, hemoglobin A1c (HbA1c) levels were lower with evacetrapib than placebo (7.08% vs 7.15%, p=0.023). Composite event rates were higher in patients with DM than without DM (Kaplan-Meier estimates: 15.2% vs 10.6%, HR 1.46, 95% CI 1.30 to 1.64, p<0.001). In the DM group, event rates for the composite endpoint (14.5% evacetrapib vs 16% placebo, HR 0.95, 95% CI 0.85 to 1.07, p=0.38) and individual components of the composite were similar for both evacetrapib and placebo groups. No significant treatment interaction between treatment assignment and diabetes status was noted.

Conclusion: Despite a favorable increase in HDL, and decreases in LDL and HbA1c levels in patients with DM, we observed no benefits of treatment with evacetrapib on prespecified clinical outcomes in this high-risk population.
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http://dx.doi.org/10.1136/bmjdrc-2019-000943DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7073792PMC
March 2020

Association of adoption of transradial access for percutaneous coronary intervention in ST elevation myocardial infarction with door-to-balloon time.

Catheter Cardiovasc Interv 2020 08 27;96(2):E165-E173. Epub 2020 Feb 27.

Heart and Vascular Institute Center for Healthcare Delivery Innovation, Cleveland Clinic, Cleveland, Ohio.

Objectives: We aimed to study adoption of transradial primary percutaneous coronary intervention (TR-PPCI) for ST elevation myocardial infarction (STEMI) ("radial first" approach) and its association with door-to-balloon time (D2BT).

Background: TR-PPCI for STEMI is underutilized in the United States due to concerns about prolonging D2BT. Whether operators and hospitals adopting a radial first approach in STEMI incur prolonged D2BT is unknown.

Methods: In 1,272 consecutive cases of STEMI with PPCI at our hospital from January 1, 2011, to December 31, 2016, we studied TR-PPCI adoption and its association with D2BT including a propensity matched analysis of similar risk TR-PPCI and trans-femoral primary PCI (TF-PPCI) patients.

Results: With major increases in hospital-level TR-PPCI (hospital TR-PPCI rate: 2.6% in 2011 to 79.4% in 2016, p-trend<.001) and operator-level TR-PPCI (mean operator TR-PPCI rate: 2.9% in 2011 to 81.1% in 2016, p-trend = .005), median hospital level D2BT decreased from 102 min [81, 142] in 2011 to 84 min [60, 105] in 2016 (p-trend<.001). TF crossover (10.3%; n = 57) was not associated with unadjusted D2BT (TR-PPCI success 91 min [72, 112] vs. TF crossover 99 min [70, 115], p = .432) or D2BT adjusted for study year and presenting location (7.2% longer D2BT with TF crossover, 95% CI: -4.0% to +18.5%, p = .208). Among 273 propensity-matched pairs, unadjusted D2BT (TR-PPCI 98 [78, 117] min vs. TF-PPCI 101 [76, 132] min, p = .304), and D2BT adjusted for study year and presenting location (5.0% shorter D2BT with TR-PPCI, 95% CI: -12.4% to +2.4%, p = .188) were similar.

Conclusions: TR-PPCI can be successfully implemented without compromising D2BT performance.
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http://dx.doi.org/10.1002/ccd.28785DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7496393PMC
August 2020

Fifth generation troponin T assay is subject to antibody interference.

Clin Chim Acta 2020 Jun 6;505:98-99. Epub 2020 Feb 6.

Department of Laboratory Medicine, Cleveland Clinic, Cleveland, OH 44195, USA. Electronic address:

Background: The fifth generation (high-sensitivity) troponin T assay offers increased precision and analytical sensitivity to the predecessor method. The assay has proven utility in risk stratification and patient management. Upon clinical suspicion and discordant 4th generation troponin T and troponin I results, we investigated a sample for suspected interfering substances to the 5th generation troponin T assay.

Methods: The analysis included a serial dilution, treatment with polyethylene glycol, commercial antibody blocking reagents, and size exclusion chromatography.

Results: The sample diluted linearly (R = 0.9957); however, experienced a dramatic reduction in concentration after both the polyethylene glycol and blocking agent treatment. Finally, size exclusion chromatography demonstrated assay reactivity around 970 kDa range.

Conclusions: These experiments elucidate a heterophilic antibody interference to the assay, and demonstrate potential measures to discern the interference.
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http://dx.doi.org/10.1016/j.cca.2020.02.006DOI Listing
June 2020

Atrial fibrillation ablation in patients with transthyretin cardiac amyloidosis.

Europace 2020 02;22(2):259-264

Department of Cardiovascular Medicine, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44195, USA.

Aims: Atrial fibrillation (AF) occurs in as many as 70% of patients with transthyretin cardiac amyloidosis (ATTR CA). The aim of our study was to investigate the impact of AF ablation on freedom from recurrent arrhythmia, hospitalization for AF or heart failure (HF), and mortality.

Methods And Results: This was a retrospective observational cohort study of 72 patients with ATTR CA and AF, of whom 24 underwent AF ablation and were matched in a 2:1 manner based on age, gender, ATTR CA stage, New York Heart Association functional class, ejection fraction, and date of AF diagnosis with 48 patients with ATTR CA and AF undergoing medical management. During a mean follow-up of 39 ± 26 months, 10 (42%) patients remained free of recurrent arrhythmia following ablation. Ablation was significantly more effective in those with Stage I or II ATTR CA, with 9/14 (64%) patients with Stage I or II ATTR CA remaining free of recurrent arrhythmia compared to only 1/10 (10%) patients with Stage III disease (P = 0.005). Death occurred in 7 (29%) patients in the ablation group compared to 36 (75%) in the non-ablation arm (P = 0.01). Rates of ischaemic stroke were similar in both groups. Ablation was associated with a significant reduction in the frequency of hospitalization for HF/arrhythmia (1.7 ± 2.4 hospitalizations vs. 4 ± 3.5, P = 0.005). On Cox proportional hazards analyses, ablation was associated with improved survival (hazard ratio 0.38, 95% confidence intervals 0.17-0.86; P = 0.02).

Conclusion: Atrial fibrillation ablation is associated with reduced mortality in ATTR CA and is most effective when performed earlier during the disease process.
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http://dx.doi.org/10.1093/europace/euz314DOI Listing
February 2020

Impact of Baseline Glycemic Control on Residual Cardiovascular Risk in Patients With Diabetes Mellitus and High-Risk Vascular Disease Treated With Statin Therapy.

J Am Heart Assoc 2020 01 19;9(1):e014328. Epub 2019 Dec 19.

Heart and Vascular Institute Cleveland Clinic Foundation Cleveland OH.

Background The contemporary impact of glycemic control on patients with diabetes mellitus at high cardiovascular risk remains unclear. We evaluated the utility of hemoglobin A1c (HbA1c) as a marker of risk on the composite end point of cardiovascular death, nonfatal myocardial infarction, stroke, hospitalization for unstable angina, and coronary revascularization in an optimally treated population with diabetes mellitus and established coronary artery disease enrolled in the ACCELERATE (Assessment of Clinical Effects of Cholesteryl Ester Transfer Protein Inhibition With Evacetrapib in Patients at a High Risk for Vascular Outcomes) trial. Methods and Results We included all patients with established diabetes mellitus and measured HbA1c (N=8145) and estimated Kaplan-Meier (KM) events rates, stratified by increasing baseline HbA1c levels censored at 30 months. We then performed a multivariable regression for the primary end point. Increasing baseline HbA1c was strongly associated with the occurrence of the primary end point (KM estimate, 12.6-18.2; <0.001). Increasing baseline HbA1c was also associated with the triple end point of death, nonfatal myocardial infarction, and stroke (KM estimate, 7.8-11.3; =0.003) as well as the individual end points of nonfatal myocardial infarction (KM estimate, 3.1-7.0; <0.001), hospitalization for unstable angina (KM estimate, 1.8-5.0; =0.003), and revascularization (KM estimate, 7.3-11.1; =0.001), although not stroke (KM estimate, 1.4-2.4; =0.45). The rates of cardiovascular mortality (KM estimate, 2.6-4.3; =0.21) and all-cause mortality (KM estimate, 4.8-5.9; =0.21) were similar regardless of baseline HbA1c levels. When adjusting for relevant baseline characteristics, baseline HbA1c was an independent predictor for the primary end point (hazard ratio, 1.06; 95% CI, 1.02-1.11; =0.003). Conclusions Glycemic control, as measured by HbA1c, remains strongly and independently associated with cardiovascular outcomes in high-risk patients with diabetes mellitus on statin therapy. Clinical Trial Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT01687998.
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http://dx.doi.org/10.1161/JAHA.119.014328DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6988169PMC
January 2020