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Advanced therapies for end-stage heart failure

Katz, Jason N; Waters, Sarah B; Hollis, Ian B; Chang, Patricia P
Management of the advanced heart failure patient can be complex. Therapies include cardiac transplantation and mechanical circulatory support, as well inotropic agents for the short-term. Despite a growing armamentarium of resources, the clinician must carefully weigh the risks and benefits of each therapy to develop an optimal treatment strategy. While cardiac transplantation remains the only true "cure" for end-stage disease, this resource is limited and the demand continues to far outpace the supply. For patients who are transplant-ineligible or likely to succumb to their illness prior to transplant, ventricular assist device therapy has now become a viable option for improving morbidity and mortality. Particularly for the non-operative patient, intravenous inotropes can be utilized for symptom control. Regardless of the treatments considered, care of the heart failure patient requires thoughtful dialogue, multidisciplinary collaboration, and individualized care. While survival is important, most patients covet quality of life above all outcomes. An often overlooked component is the patient's control over the dying process. It is vital that clinicians make goals-of-care discussions a priority when seeing patients with advanced heart failure. The use of palliative care consultation is well-validated and facilitates these difficult conversations to ensure that all patient needs are ultimately met.
PMCID:4347211
PMID: 24251460
ISSN: 1875-6557
CID: 5788092

A multicenter analysis of clinical hemolysis in patients supported with durable, long-term left ventricular assist device therapy

Katz, Jason N; Jensen, Brian C; Chang, Patricia P; Myers, Susan L; Pagani, Francis D; Kirklin, James K
BACKGROUND:Despite the beneficial effects of mechanical circulatory support (MCS), the majority of patients ultimately will have an adverse event. Although hemolysis is common among temporary devices, the incidence and clinical significance of hemolysis in patients managed with long-term, durable left ventricular assist device (LVAD) therapy is largely unknown. METHODS:Data were obtained from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). All adults who received a continuous-flow LVAD (CF-LVAD) between June 2006 and March 2012 were included. A hemolytic event was defined as a plasma-free hemoglobin >40 mg/dl in association with clinical signs of hemolysis occurring at least 72 hours after LVAD implant. Descriptive statistics, time-dependent analyses and multivariable modeling were employed for statistical purposes. RESULTS:A total of 4,850 patients followed for a mean of 11.1 months comprised the final study population. There were 340 hemolytic events in 260 patients. Freedom from hemolysis was 97% at 3 months, 94% at 1 year and 91% at 2 years. Mean time from implant to first hemolysis event was 7.4 months. Younger age (<60 years) was independently associated with greater hemolysis (p < 0.001). Thrombotic device malfunction, device exchange and mortality were all significantly higher after hemolysis, with the greatest risk for each occurring within 6 months. CONCLUSIONS:Hemolysis is not a rare event after CF-LVAD implantation and is associated with an early increase in morbidity and death. Future study should focus on other device and implant characteristics that may lead to hemolytic events, as well as appropriate strategies for managing affected patients.
PMID: 25582036
ISSN: 1557-3117
CID: 5782902

Sharing the care of mechanical circulatory support: collaborative efforts of patients/caregivers, shared-care sites, and left ventricular assist device implanting centers

Kiernan, Michael S; Joseph, Susan M; Katz, Jason N; Kilic, Ahmet; Rich, Jonathan D; Tallman, Mark P; Van Buren, Peter; Lyons, James J; Bethea, Brian; Eckman, Peter; Gosev, Igor; Lee, Sangjin S; Soleimani, Behzad; Takayama, Hiroo; Patel, Chetan B; Uriel, Nir; ,
PMID: 25991805
ISSN: 1941-3297
CID: 5782912

Delirium is a robust predictor of morbidity and mortality among critically ill patients treated in the cardiac intensive care unit

Pauley, Eric; Lishmanov, Anton; Schumann, Sara; Gala, Gary J; van Diepen, Sean; Katz, Jason N
BACKGROUND:Delirium is common in the medical and surgical intensive care unit (ICU), and its association with morbidity and mortality is well described. Despite emerging data, which have highlighted a growing critical care burden in the contemporary cardiac ICU (CICU), much less is known about delirium in this specialized setting. METHODS AND RESULTS/RESULTS:Records for consecutive CICU patients aged ≥18 years who were admitted to our academic, tertiary care institution from December 2012 to March 2014 for a primary cardiovascular diagnosis were reviewed. Only those with a documented Confusion Assessment Method for ICU score were included in the final analysis. Baseline characteristics, resource use, and outcomes were collected. Disease severity was assessed using the modified Acute Physiology and Chronic Health Evaluation II score and the Simplified Acute Physiology ScoreII. Multivariable logistic and linear regression models were constructed to evaluate the association between CICU delirium, length of stay, and death. Among 590 patients included, the prevalence of CICU delirium was 20.3%. Delirious patients were older, had greater disease severity, required longer ICU stays (5 vs 2 days; P < .001), and had higher mortality (27% vs 3%; P < .001). In the adjusted setting, delirium remained strongly associated with both increased mortality (P < .001) and length of stay (P = .001). CONCLUSIONS:In those with cardiac critical illness, delirium is common and associated with worse survival and greater resource consumption. Future study is needed to validate these findings and to develop effective strategies for the early identification and treatment of the delirious CICU patient.
PMID: 26093867
ISSN: 1097-6744
CID: 5782922

The unmet need for addressing cardiac issues in intensive care research

van Diepen, Sean; Granger, Christopher B; Jacka, Michael; Gilchrist, Ian C; Morrow, David A; Katz, Jason N
OBJECTIVE:Patients with primary cardiovascular disorders and comorbidities are commonly admitted to ICUs; however, little is known about the current state of cardiac research being conducted in these adult ICU patients. DESIGN/METHODS:Retrospective analysis. PATIENTS OR SUBJECTS/METHODS:None. SETTING/METHODS:In separate searches of ongoing phase II-IV clinical trials registered with ClinicalTrials.gov and funding grants available in the Canadian Institutes for Health Research funding decision database between 1999 and 2012, we identified all research initiatives focused on adult ICU patients. INTERVENTIONS/METHODS:None. MEASUREMENTS AND MAIN RESULTS/RESULTS:The primary outcome of interest was the proportion of cardiac-specific ICU studies, defined as any involving a cardiac population with a cardiac intervention (or observation for observational analyses) and/or a cardiac outcome. A total of 192 unique studies including adult ICU patients were identified from the ClinicalTrials.gov database. These were most commonly classified as respiratory or ventilation (19%), infectious (14.1%), or neurologic (12.0%) in focus. A total of 105 grants were identified in the Canadian Institutes for Health Research database. Funded studies most commonly addressed respiratory or ventilator questions (18.1%), infectious disease issues (12.4%), or hematological/thrombosis questions (9.5%). Only 4.6% of all ICU studies in ClinicalTrials.gov and 1.9% of all Canadian Institutes for Health Research grants could be considered cardiac. CONCLUSIONS:These findings highlight the relative paucity of cardiac-specific research in the intensive care setting relative to the high prevalence of acute cardiac diseases and comorbidities. This observed disparity warrants timely attention and should lead to meaningful research opportunities aimed at improving the outcomes of critically ill cardiac patients.
PMID: 25243816
ISSN: 1530-0293
CID: 5783092

Cardiovascular Critical Care: A Perceived Deficiency Among U.S. Trainees

Hill, Terence; Means, Gregory; van Diepen, Sean; Paul, Timir; Katz, Jason N
OBJECTIVE:Acute and chronic cardiovascular comorbidities are common among critically ill individuals. It is unclear if current critical care fellowship trainees feel adequately prepared to manage these conditions. DESIGN/METHODS:Prospective, cross-sectional survey. PATIENTS OR SUBJECTS/METHODS:Trainees enrolled in U.S. critical care training programs. SETTING/METHODS:Accredited pulmonary/critical care, surgery/critical care, anesthesiology/critical care, and stand-alone critical care training programs. INTERVENTIONS/METHODS:None. MEASUREMENTS AND MAIN RESULTS/RESULTS:A 19-item survey assessing trainee confidence in the management of cardiac critical illness and the performance of cardiac-specific critical care interventions was constructed using Accreditation Council for Graduate Medical Education recommendations as a reference. After validation, the survey was electronically sent to all training programs for dissemination to their trainees. Confidence scores were measured on a Likert scale from 1 to 5. A total of 134 completed surveys were analyzed. Overall, respondents reported lower confidence in managing cardiovascular compared with noncardiovascular diseases in the ICU (4.0 vs 4.6 out of 5). Likewise, they reported lower perceived competence in performing cardiovascular procedures specific to the ICU (2.9 vs 4.5 out of 5). The majority (88%) of those surveyed felt that they would benefit from increased didactic and clinical experience in the management of cardiovascular critical illness. CONCLUSIONS:Current critical care fellows may be unprepared to deal with the increasing prevalence of cardiovascular illness in the ICU. This potential educational gap warrants timely attention to ensure that future graduates have the requisite skills necessary to manage these critically ill patients and presents a unique opportunity to develop multidisciplinary partnerships for enhancing training.
PMID: 25978338
ISSN: 1530-0293
CID: 5783102

Safety of reduced anti-thrombotic strategies in HeartMate II patients: A one-year analysis of the US-TRACE Study

Katz, Jason N; Adamson, Robert M; John, Ranjit; Tatooles, Antone; Sundareswaran, Kartik; Kallel, Faouzi; Farrar, David J; Jorde, Ulrich P
BACKGROUND: Patients with bleeding complications during left ventricular assist device (LVAD) support often require a reduction in the recommended warfarin plus aspirin regimen. To characterize those who can be safely managed with a reduced anti-thrombotic strategy, the TRACE (STudy of Reduced Anti-Coagulation/Anti-platelEt Therapy in Patients with the HeartMate II LVAS) study was initiated in the United States (U.S.) and Europe. METHODS: The TRACE U.S. arm enrolled HeartMate II (HMII; Thoratec) outpatients on a regimen of reduced anti-thrombotic therapy (RT), defined as vitamin K antagonist (warfarin) only, aspirin only, or no anti-thrombotic agent. The indication for RT, changes in anti-thrombotic therapies, and patient outcomes after RT were documented. Results for patients reaching 12 months or outcome are presented here. RESULTS: Between April 2012 and June 2013, 100 HMII outpatients (85% men) on RT (median age 64.5 [interquartile range, 32, 82] years, 61% with ischemic etiology, 69% destination therapy) were enrolled from 9 U.S. sites. The primary reason for RT initiation was in response to a bleeding event (82%). Pharmacotherapy at RT initiation included warfarin only (38%), aspirin only (28%), or no anti-thrombotic agent (34%). Freedom from ischemic stroke at 1 year was 93.8% +/- 2.5%, and freedom from device thrombosis was 92.7% +/- 2.7%. Despite RT, a subsequent bleeding event occurred in 52%. CONCLUSIONS: Reducing anti-thrombotic therapies in response to bleeding among HMII patients was achievable but may be associated with a higher risk for device thrombosis. Furthermore, despite an RT strategy, bleeding often will persist in those prone to such events.
PMID: 26277569
ISSN: 1557-3117
CID: 2036232

A novel link between G6PD deficiency and hemolysis in patients with continuous-flow left ventricular assist devices

Alhosaini, Hassan; Jensen, Brian C; Chang, Patricia P; Sheridan, Brett C; Katz, Jason N
PMID: 24290168
ISSN: 1557-3117
CID: 5788102

Infection and noncardiovascular death in the elderly-Heart failure's dirty little secret [Comment]

Rose-Jones, Lisa; Katz, Jason N
PMID: 24406449
ISSN: 1532-8414
CID: 5788112

Development and preliminary assessment of a critical care ultrasound course in an adult pulmonary and critical care fellowship program

Hulett, Cidney S; Pathak, Vikas; Katz, Jason N; Montgomery, Sean P; Chang, Lydia H
BACKGROUND:The focused ultrasound examination has become increasingly recognized as a safe and valuable diagnostic tool for the bedside assessment of the critically ill patient. We implemented a dedicated on-site critical care ultrasonography curriculum with the goal of developing a model for teaching ultrasound skills to pulmonary and critical care medicine fellows. METHODS:The program was comprised of blended didactic and bedside sessions in the following topic domains: fundamentals; vascular access and diagnosis; and abdominal, thoracic, and cardiac ultrasonography. Formal knowledge and image acquisition assessments were performed before and after the program to assess success in meeting predefined learning objectives. Participants completed surveys (on Likert scale 1-5) before and after the program to assess their confidence in ultrasonography knowledge and skills as well as their perception as to training effectiveness. RESULTS:The preintervention knowledge and bedside image acquisition scores were 71 and 32%, respectively. The global preintervention score was 51%. All postintervention measures demonstrated significant improvement: 89% (P < 0.01), 86% (P < 0.0001), and 87% (P < 0.0001). Preintervention participant confidence in their ultrasound knowledge and skill was 2.9/5, which improved to 4.3/5 (P = 0.007) after intervention. Participants rated the curriculum as meeting course objectives at a mean of 4.8/5. CONCLUSIONS:At one academic medical center, the knowledge of eight adult pulmonary and critical care fellowship trainees regarding critical care ultrasound was high at baseline; however, bedside image acquisition skills were poor. A dedicated 6-week educational intervention resulted in highly significant improvements in subject knowledge and image acquisition skills. These preliminary results warrant validation studies at other medical centers.
PMID: 24735177
ISSN: 2325-6621
CID: 5788122