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Aspirin and Left Ventricular Assist Devices Rationale and Design for The International Randomized, Placebo-Controlled, Non-Inferiority ARIES HM3 Trial

Mehra, Mandeep R; Crandall, Daniel L; Gustafsson, Finn; Jorde, Ulrich P; Katz, Jason N; Netuka, Ivan; Uriel, Nir; Connors, Jean M; Sood, Poornima; Heatley, Gerald; Pagani, Francis D
AIMS/OBJECTIVE:Over decades, Left Ventricular Assist Device (LVAD) technology has transitioned from less durable bulky pumps to smaller continuous-flow pumps which have substantially improved long-term outcomes and quality of life. Contemporary LVAD therapy is beleaguered by hemocompatibility related adverse events including thrombosis, stroke and bleeding. A fully magnetically levitated pump, the HeartMate 3 (HM3, Abbott Labs, USA) LVAD has been shown to be superior to the older HeartMate II (HMII, Abbott Labs, USA) pump by improving hemocompatibility. Experience with the HM3 LVAD suggests near elimination of de-novo pump thrombosis, a significant reduction in stroke rates, and only a modest decrease in bleeding complications. Since the advent of continuous-flow LVAD therapy, patients have been prescribed a combination of aspirin and anticoagulation therapy on the presumption that platelet activation and perturbations to the hemostatic axis determine their necessity. Observational studies in patients implanted with the HM3 LVAD who suffer bleeding have suggested a signal of reduced subsequent bleeding events with withdrawal of aspirin. The notion of whether antiplatelet therapy can be avoided in an effort to reduce bleeding complications has now been advanced. METHODS:To evaluate this hypothesis and its clinical benefits, the Antiplatelet Removal and HemocompatIbility EventS with the HeartMate 3 Pump (ARIES HM3) has been introduced as the first-ever international prospective, randomized, double-blinded and placebo-controlled, non-inferiority trial in a patient population implanted with a LVAD. CONCLUSION/CONCLUSIONS:This paper reviews the biological and clinical role of aspirin (100 mg) with LVADs and discusses the rationale and design of the ARIES HM3 trial. This article is protected by copyright. All rights reserved.
PMID: 34142415
ISSN: 1879-0844
CID: 4917742

Mechanical Complications of Acute Myocardial Infarction: A Scientific Statement From the American Heart Association

Damluji, Abdulla A; van Diepen, Sean; Katz, Jason N; Menon, Venu; Tamis-Holland, Jacqueline E; Bakitas, Marie; Cohen, Mauricio G; Balsam, Leora B; Chikwe, Joanna
Over the past few decades, advances in pharmacological, catheter-based, and surgical reperfusion have improved outcomes for patients with acute myocardial infarctions. However, patients with large infarcts or those who do not receive timely revascularization remain at risk for mechanical complications of acute myocardial infarction. The most commonly encountered mechanical complications are acute mitral regurgitation secondary to papillary muscle rupture, ventricular septal defect, pseudoaneurysm, and free wall rupture; each complication is associated with a significant risk of morbidity, mortality, and hospital resource utilization. The care for patients with mechanical complications is complex and requires a multidisciplinary collaboration for prompt recognition, diagnosis, hemodynamic stabilization, and decision support to assist patients and families in the selection of definitive therapies or palliation. However, because of the relatively small number of high-quality studies that exist to guide clinical practice, there is significant variability in care that mainly depends on local expertise and available resources.
PMID: 34126755
ISSN: 1524-4539
CID: 4911442

Association between Respiratory Failure and Clinical Outcomes in Patients with Acute Heart Failure: Analysis of 5 Pooled Clinical Trials

Miller, P Elliott; Van Diepen, Sean; Metkus, Thomas S; Alviar, Carlos L; Rayner-Hartley, Erin; Rathwell, Sarah; Katz, Jason N; Ezekowitz, Justin; Desai, Nihar R; Ahmad, Tariq
BACKGROUND:Despite a temporal increase in respiratory failure in patients hospitalized with acute heart failure (HF), clinical trials have largely not reported the incidence or associated clinical outcomes for patients requiring mechanical ventilation. METHODS AND RESULTS/RESULTS:After pooling 5 acute HF clinical trials, we used multivariable logistic regression adjusted for demographics, comorbidities, examinations, and laboratory findings to assess associations between mechanical ventilation and clinical outcomes. Among the 8296 patients, 210 (2.5%) required mechanical ventilation. Age, sex, smoking history, baseline ejection fraction, HF etiology, and the proportion of patients randomized to treatment or placebo in the original clinical trial were similar between groups (all, P > 0.05). Baseline diabetes mellitus was more common in the mechanical ventilation group (P = 0.02), but other comorbidities, including chronic lung disease, were otherwise similar (all P > 0.05). HF rehospitalization at 30 days (12.7% vs 6.6%, P < 0.001) and all-cause 60-day mortality (33.3% vs 6.1%, P < 0.001) was higher among patients requiring mechanical ventilation. After multivariable adjustment, mechanical ventilation use was associated with an increased 30-day HF rehospitalization (odds ratio 2.03; 95% confidence interval, 1.29-3.21, P = 0.002), 30-day mortality (odds ratio 10.40; 95% confidence interval, 7.22-14.98, P < 0.001), and 60-day mortality (odds ratio 7.68; 95% confidence interval, 5.50-10.74, P < 0.001). The influence of mechanical ventilation did not differ by HF etiology or baseline ejection fraction (both, interaction P > 0.20). CONCLUSIONS:Respiratory failure during an index hospitalization for acute HF was associated with increased rehospitalization and all-cause mortality. The development of respiratory failure during an acute HF admission identifies a particularly vulnerable population, which should be identified for closer monitoring.
PMID: 33556546
ISSN: 1532-8414
CID: 4814752

Older Adults in the Cardiac Intensive Care Unit: Factoring Geriatric Syndromes in the Management, Prognosis, and Process of Care: A Scientific Statement From the American Heart Association

Damluji, Abdulla A; Forman, Daniel E; van Diepen, Sean; Alexander, Karen P; Page, Robert L; Hummel, Scott L; Menon, Venu; Katz, Jason N; Albert, Nancy M; Afilalo, Jonathan; Cohen, Mauricio G; ,
Longevity is increasing, and more adults are living to the stage of life when age-related biological factors determine a higher likelihood of cardiovascular disease in a distinctive context of concurrent geriatric conditions. Older adults with cardiovascular disease are frequently admitted to cardiac intensive care units (CICUs), where care is commensurate with high age-related cardiovascular disease risks but where the associated geriatric conditions (including multimorbidity, polypharmacy, cognitive decline and delirium, and frailty) may be inadvertently exacerbated and destabilized. The CICU environment of procedures, new medications, sensory overload, sleep deprivation, prolonged bed rest, malnourishment, and sleep is usually inherently disruptive to older patients regardless of the excellence of cardiovascular disease care. Given these fundamental and broad challenges of patient aging, CICU management priorities and associated decision-making are particularly complex and in need of enhancements. In this American Heart Association statement, we examine age-related risks and describe some of the distinctive dynamics pertinent to older adults and emerging opportunities to enhance CICU care. Relevant assessment tools are discussed, as well as the need for additional clinical research to best advance CICU care for the already dominating and still expanding population of older adults.
PMID: 31813278
ISSN: 1524-4539
CID: 5788212

Contemporary Comprehensive Monitoring of Veno-arterial Extracorporeal Membrane Oxygenation Patients

Bhatia, Meena; Katz, Jason N
The use of veno-arterial extracorporeal membrane oxygenation (VA ECMO) has increased substantially over the past few decades. Today's clinicians now have a powerful means with which to salvage a growing population of patients at risk for cardiopulmonary collapse. At the same time, patients supported with VA ECMO have become increasingly more complex. The successful use of VA ECMO depends not only on selecting the appropriate patients, but also on effectively navigating a potential torrent of device- and patient-related complications until ECMO is no longer needed. A multitude of monitoring tools are now available to help the treatment team determine the adequacy of care, to detect problems, and to anticipate recovery. Monitoring with devices such as the Swan-Ganz catheter, transthoracic and transesophageal echocardiography, chest radiography, and near-infrared spectroscopy can provide useful information to complement routine clinical care. Leveraging data derived from the ECMO circuit itself also can be instrumental in both evaluating the sufficiency of support and troubleshooting complications. Each of these tools, however, has its own unique sets of limitations and liabilities. A thorough understanding of these risks and benefits is critical to the contemporary care of the individual managed with VA ECMO. In addition, more research is needed to establish optimal evidence-based care pathways and best-practice principles for using these devices to improve patient outcomes.
PMID: 31924449
ISSN: 1916-7075
CID: 5788222

Use of Temporary Mechanical Circulatory Support for Management of Cardiogenic Shock Before and After the United Network for Organ Sharing Donor Heart Allocation System Changes

Varshney, Anubodh S; Berg, David D; Katz, Jason N; Baird-Zars, Vivian M; Bohula, Erin A; Carnicelli, Anthony P; Chaudhry, Sunit-Preet; Guo, Jianping; Lawler, Patrick R; Nativi-Nicolau, Jose; Sinha, Shashank S; Teuteberg, Jeffrey J; van Diepen, Sean; Morrow, David A; ,
IMPORTANCE:The new United Network for Organ Sharing (UNOS) donor heart allocation system gives priority to patients supported with nondischargeable mechanical circulatory support (MCS) devices while awaiting heart transplant. Whether there has been a change in temporary MCS use in cardiac intensive care units (CICUs) since the implementation of this policy is unknown. OBJECTIVES:To examine whether the UNOS donor heart allocation system revision in October 2018 was associated with changes in temporary MCS use in CICUs and whether temporary MCS use differed between US transplant centers and US nontransplant centers and Canadian centers. DESIGN, SETTING, AND PARTICIPANTS:In this cohort study, 14 centers from the Critical Care Cardiology Trials Network (CCCTN), a multicenter network of tertiary CICUs in North America, contributed 2-month snapshots of consecutive medical CICU admissions between September 1, 2017, and September 1, 2018 (prerevision period), and October 1, 2018, and September 1, 2019 (postrevision period). CICUs were classified as US transplant centers (n = 7) or other CICUs (US nontransplant centers or Canadian centers; n = 7). EXPOSURE:Revision to the UNOS donor heart allocation system. MAIN OUTCOMES AND MEASURES:Treatment with temporary MCS (intra-aortic balloon pump, microaxial intracardiac ventricular assist device, percutaneous centrifugal ventricular assist device, venoarterial extracorporeal membrane oxygenation, or surgically implanted, nondischargeable MCS device) during hospital admission. RESULTS:A total of 384 admissions for acute, decompensated, heart failure-related cardiogenic shock (ADHF-CS) were included, among which 248 (64.6%) were to US transplant centers; 126 admissions (51%) were in the prerevision period and 122 (49%) were in the postrevision period. The mean (SD) patient age was 61.2 (14.6) years; 246 patients (64.1%) were male. The proportion of admissions with ADHF-CS managed with temporary MCS at US transplant centers significantly increased from 25.4% (32 of 126 admissions) before to 42.6% (52 of 122 admissions) after the UNOS allocation system changes (P = .004). In other CICUs, the proportion did not significantly change (24.5% [13 of 53 admissions] to 24.1% [20 of 83 admissions]; P = .95). After multivariable adjustment, patients admitted to US transplant centers in the postrevision period were more likely to receive temporary MCS compared with those admitted in the prerevision period (adjusted odds ratio, 2.19; 95% CI, 1.13-4.24; P = .02). CONCLUSIONS AND RELEVANCE:In the year after implementation of the new UNOS donor heart allocation system, temporary MCS use in patients admitted with ADHF-CS increased in US transplant centers but not in other CICUs. Whether this shift in practice will affect outcomes of patients with ADHF-CS or organ distribution should be evaluated.
PMCID:7160750
PMID: 32293644
ISSN: 2380-6591
CID: 5782662

Telehealth transformation: COVID-19 and the rise of virtual care

Wosik, Jedrek; Fudim, Marat; Cameron, Blake; Gellad, Ziad F; Cho, Alex; Phinney, Donna; Curtis, Simon; Roman, Matthew; Poon, Eric G; Ferranti, Jeffrey; Katz, Jason N; Tcheng, James
The novel coronavirus disease-19 (COVID-19) pandemic has altered our economy, society, and healthcare system. While this crisis has presented the U.S. healthcare delivery system with unprecedented challenges, the pandemic has catalyzed rapid adoption of telehealth, or the entire spectrum of activities used to deliver care at a distance. Using examples reported by U.S. healthcare organizations, including ours, we describe the role that telehealth has played in transforming healthcare delivery during the 3 phases of the U.S. COVID-19 pandemic: (1) stay-at-home outpatient care, (2) initial COVID-19 hospital surge, and (3) postpandemic recovery. Within each of these 3 phases, we examine how people, process, and technology work together to support a successful telehealth transformation. Whether healthcare enterprises are ready or not, the new reality is that virtual care has arrived.
PMCID:7188147
PMID: 32311034
ISSN: 1527-974x
CID: 5782672

Back to the future-Are we ready for a randomized trial of surgical versus percutaneous revascularization in cardiogenic shock? [Comment]

Katz, Jason N
PMID: 32359688
ISSN: 1097-6744
CID: 5782682

A care pathway for the cardiovascular complications of COVID-19: Insights from an institutional response

Loungani, Rahul S; Rehorn, Michael R; Newby, L Kristin; Katz, Jason N; Klem, Igor; Mentz, Robert J; Jones, W Schuyler; Vemulapalli, Sreekanth; Kelsey, Anita M; Blazing, Michael A; Piccini, Jonathan P; Patel, Manesh R
The infection caused by severe acute respiratory syndrome coronavirus-2, or COVID-19, can result in myocardial injury, heart failure, and arrhythmias. In addition to the viral infection itself, investigational therapies for the infection can interact with the cardiovascular system. As cardiologists and cardiovascular service lines will be heavily involved in the care of patients with COVID-19, our division organized an approach to manage these complications, attempting to balance resource utilization and risk to personnel with optimal cardiovascular care. The model presented can provide a framework for other institutions to organize their own approaches and can be adapted to local constraints, resource availability, and emerging knowledge.
PMCID:7252188
PMID: 32417526
ISSN: 1097-6744
CID: 5782702

Lead Extraction for Cardiovascular Implantable Electronic Device Infection in Patients With Left Ventricular Assist Devices

Black-Maier, Eric; Piccini, Jonathan P; Bishawi, Muath; Pokorney, Sean D; Bryner, Benjamin; Schroder, Jacob N; Fowler, Vance G; Katz, Jason N; Haney, John C; Milano, Carmelo A; Nicoara, Alina; Hegland, Donald D; Daubert, James P; Lewis, Robert K
OBJECTIVES:The goal of this study was to assess the utility of transvenous lead extraction for cardiovascular implantable electronic device (CIED) infection in patients with a left ventricular assist device (LVAD). BACKGROUND:The use of transvenous lead extraction for the management CIED infection in patients with a durable LVAD has not been well described. METHODS:Clinical and outcomes data were collected retrospectively among patients who underwent lead extraction for CIED infection after LVAD implantation at Duke University Hospital. RESULTS:Overall, 27 patients (n = 6 HVAD; n = 15 HeartMate II; n = 6 Heartmate III) underwent lead extraction for infection. Median (interquartile range) time from LVAD implantation to infection was 6.1 (2.5 to 14.9) months. Indications included endocarditis (n = 16), bacteremia (n = 9), and pocket infection (n = 2). Common pathogens were Staphylococcus aureus (n = 10), coagulase-negative staphylococci (n = 7), and Enterococcus faecalis (n = 3). Sixty-eight leads were removed, with a median lead implant time of 5.7 (3.6 to 9.2) years. Laser sheaths were used in all procedures, with a median laser time of 35.0 s (17.5 to 85.5s). Mechanical cutting tools were required in 11 (40.7%) and femoral snaring in 4 (14.8%). Complete procedural success was achieved in 25 (93.6%) patients and clinical success in 27 (100%). No procedural failures or major adverse events occurred. Twenty-one patients (77.8%) were alive without persistent endovascular infection 1 year after lead extraction. Most were treated with oral suppressive antibiotics after extraction (n = 23 [82.5%]). Persistent infection after extraction occurred in 4 patients and was associated with 50% 1-year mortality. CONCLUSIONS:Transvenous lead extraction for LVAD-associated CIED infection can be performed safely with low rates of persistent infection and 1-year mortality.
PMID: 32553217
ISSN: 2405-5018
CID: 5782712