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Background: Left ventricular assist devices (LVADs) have revolutionized the treatment of advanced heart failure, but proliferation of device therapy has unmasked potential complications. Reports have emerged of outflow graft narrowing due to extrinsic compression., Methods and Results: The records of patients with LVADs that had been implanted at our institution were reviewed. Those who had postimplantation computed tomography angiographies sufficient to analyze the outflow graft lumen were identified, and the studies were analyzed to characterize the outflow graft lumen. We identified 241 patients; 110 (46%) had suitable computed tomography angiographies. Of those, 15 (14%) had evidence of outflow graft lumen narrowing, all in HeartMate devices and all within the portion covered by the bend relief. Of the 15, 3 underwent invasive examination, all without intraluminal thrombus but, rather, with biodebris between the bend relief and the outflow graft. Patients with HeartWare devices had a wide range of biodebris accumulation surrounding the outflow graft but no cases of lumen narrowing. On multivariable analysis, 1) time from device implant to scan, 2) nonischemic cardiomyopathy and 3) age at implant were significantly associated with higher risk of graft narrowing., Conclusion: Outflow graft narrowing can be seen in a number of patients with HeartMate LVADs within the portion covered by the bend relief. In the limited number of patients who underwent invasive evaluation, the narrowing was found to arise from extrinsic compression rather than intraluminal thrombus. The clinical significance of this requires further investigation., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: The pulmonary artery catheter (PAC) has been used in a wide range of critically ill patients. It is not indicated for routine care of heart failure (HF), but its role in cardiogenic shock (CS) has not been clarified., Methods and Results: We conducted a retrospective cohort study with the use of the National Inpatient Sample and identified a total of 9,431,944 adult patients admitted from 2004 to 2014 with the primary diagnosis of HF (n = 8,516,528) or who developed CS (n = 915,416) during the index hospitalization. Overall, patients with PAC had increased hospital costs, length of stay, and mechanical circulatory support use. In patients with HF, PAC use was associated with higher mortality (9.9% vs 3.3%, OR 3.96; P < .001) but the excess of mortality declined over time. In those with CS, PAC was associated with lower mortality (35.1% vs 39.2%, OR 0.91; P < .001) and in-hospital cardiac arrest (14.9% vs 18.3%, OR 0.77; P < .001); this paradox persisted after propensity score matching., Conclusions: The use of PAC in CS has decreased from 2004 to 2014, although its use is now associated with improved outcomes, which may reflect better selection of patients or better use of the information to guide therapies. Our data provide reassurance that PAC use in this population is an appropriate strategy., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objective: The Kansas City Cardiomyopathy Questionnaire (KCCQ) has emerged as a patient-centered heart failure-specific health status measure. It currently lacks routine and widespread use in clinical practice and trials. The purpose of this study was to examine the correlation between KCCQ and cardiopulmonary exercise testing (CPET) parameters and clinical outcomes, compared with the New York Heart Association functional classification (NYHA)., Methods and Results: We performed a single-centered observational analysis of 432 patients who presented to the Heart Failure Department, completed the KCCQ, and underwent CPET. The 1-year clinical outcome assessed was a composite of mortality, heart failure hospitalization, and need for heart transplantation or left ventricular assist device. In the KCCQ, the physical limitation domain had a correlation with peak VO 2 similar to NYHA (r = 0.48; P < .001; and r = -0.48; P < .001; respectively), and slightly better correlation with ventilatory threshold (r = 0.42; P < .001; and r = -0.40; P < .001; respectively). According to model validation, the KCCQ physical limitation domain and NYHA were similar predictors of peak VO 2 (r 2  = 0.229; and r 2  = 0.227; respectively). KCCQ predicted the specified 1-year clinical outcome (hazard ratio 0.75, 95% confidence interval 0.69-0.82; P < .001) and provided incremental predictive ability when added to a model that included NYHA, with a net reclassification index of 76.1% (P < .001)., Conclusions: KCCQ and NYHA provide similar assessment of functional capacity. KCCQ predicts 1-year clinical outcomes, providing incremental value over NYHA. These findings support its routine use in clinical care, as well as its potential to serve as a measure in clinical trials., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: People with end-stage heart failure may have to decide about destination-therapy left ventricular assist device (DT-LVAD). Individuals facing difficult decisions often rely on heuristics, such as anchoring, which predictably bias decision outcomes. We aimed to investigate whether showing a larger historical Heartmate XVE creates an anchoring effect, making the smaller Heartmate II (HMII) appear more favorable., Methods: With the use of Amazon Mechanical Turk, participants watched videos asking them to imagine themselves dying of end-stage heart failure, then were presented the option of LVAD as potentially life-prolonging therapy. Participants were randomized to a control group who were only shown the HMII device, and the intervention group who saw the XVE device before the HMII. Participants then completed surveys., Results: A total of 487 participants completed the survey (control = 252; intervention = 235); 79% were <40 years of age, 84% were white, and 55% were male. The intervention group was not more likely to accept the LVAD therapy (68% vs 61%; P = .37). However, participants in the intervention group were more likely (51% vs 17%; P < .01) to agree or strongly agree with the statement that the HMII was "smaller than expected." Participants in the intervention group were also more likely to rate the size of the device as "important" or "very important" in their decision (61% vs 46%; P < .01)., Conclusions: Although the XVE anchor did not affect likelihood of accepting the LVAD, it did affect device perception. This article highlights an important point with clinical implications: factors such as anchoring have the potential to inappropriately influence perceptions and decisions and should be carefully considered in research and practice., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: Insufficient data delineate outcomes for Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 1 patients with the total artificial heart (TAH)., Methods: We studied 66 consecutive patients implanted with the TAH at our institution from 2006 through 2012 and compared outcome by INTERMACS profile. INTERMACS profiles were adjudicated retrospectively by a reviewer blinded to clinical outcomes., Results: Survival after TAH implantation at 6 and 12 months was 76% and 71%, respectively. INTERMACS profile 1 patients had decreased 6-month survival on the device compared with those in profiles 2-4 (74% vs 95%, log rank: P = .015). For the 50 patients surviving to heart transplantation, the 1-year posttransplant survival was 82%. There was no difference in 1-year survival when comparing patients in the INTERMACS 1 profile with less severe profiles (79% vs 84%; log rank test P = .7; hazard ratio [confidence interval] 1.3 [0.3-4.8])., Conclusions: Patients implanted with the TAH as INTERMACS profile 1 had reduced survival to transplantation compared with less sick profiles. INTERMACS profile at the time of TAH implantation did not affect 1-year survival after heart transplantation., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: Given the importance of patients' health-related quality of life (HRQL) after mechanical circulatory support (MCS) device implantation, the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) collects the Kansas City Cardiomyopathy Questionnaire (KCCQ) before and after MCS. The success of data collection and potential implications of missing data on HRQL analyses are unknown., Methods: We examined the frequency and reasons for not collecting baseline and 3-month KCCQ data across INTERMACS sites from May 2012 to December 2013. Hierarchical logistic regression was used to examine site variability (median odds ratios [MOR]) for not collecting KCCQ data to demonstrate the degree to which some sites can collect more complete data than others., Results: Among 3960 and 3523 patients participating in INTERMACS before and 3 months after left ventricular assist device implantation, the KCCQ was not collected in 43.1% at baseline (range across sites, 0-100%) and 40.9% (range, 0-100%) at follow-up. The most common reasons for incomplete KCCQ data at baseline were that the patient was too sick (13.9%) and consent to participate in research was not obtained (12.4%). Significant variation across sites was observed for missingness because of patient (MOR, 2.8; P < .001) and administrative (MOR, 4.8; P < .001) reasons. The most variable patient reasons were that the patients were too stressed (MOR, 7.2; P < .001) and too busy (MOR, 10.6; P < .001). The most variable administrative reasons were that the coordinator was too busy/forgot (MOR, 7.1; P < .001) and miscellaneous reasons (MOR, 8.7; P < .001). At 3 months, significant variation persisted for both patient (MOR, 2.7; P < .001) and administrative (MOR, 3.5; P < .001) reasons. The most variability across sites was that the patient was too busy (MOR, 6.0, P < .001) and that the coordinator was too busy/forgot (MOR, 5.8; P < .001)., Conclusions: Sites vary substantially in collecting KCCQ data, and many of these variations seem addressable. Improving the consistency of HRQL data collection can improve the value of INTERMACS in defining the patient-centered benefits of MCS treatment., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: The use of left ventricular assist devices (LVADs) in the United States has increased since the Food and Drug Administration approved the 1st device in 1994. Despite a rapid increase in the number of LVADs implanted per year, there are substantial variations in procedure volume among hospitals and surgeons. This study evaluated the association between hospital and surgeon volumes of LVAD procedures and in-hospital mortality., Methods and Results: We conducted a retrospective cross-sectional analysis of all patient discharges after an LVAD implantation from University HealthSystem Consortium (UHC) academic medical center members from January 2007 through June 2012. With the use of International Classification of Diseases-9th Edition, Clinical Modification, procedure code 37.66, we identified 7714 patients who received an LVAD from 581 surgeons across 88 hospitals. The primary outcome was all-cause in-hospital mortality. Annual hospital and surgeon LVAD procedure volumes were evaluated as both continuous variables and quintiles. Hierarchical binary logistic regression models were fitted to test the association of in-hospital mortality with hospital and surgeon volume, controlling for hospital and patient characteristics. Hospital volume was not associated with lower in-hospital mortality. Highest annual surgeon volume quintile was a significant predictor of lower in-hospital mortality (odds ratio 1.69; P < .001); this model had the highest predictive accuracy, with area under the receiver operating characteristic curve of 0.79., Conclusions: Surgeons' LVAD procedure volume, not annual hospital procedure volume, was associated with in-hospital mortality., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: Whether the routine use of continuous-flow left ventricular assist devices (LVAD) has affected gender differences in outcomes for patients listed for heart transplantation (HT) is unclear., Methods and Results: We identified 20,468 adults (25% women) listed as status 1A or 1B for HT from 2000 to 2014. Sex differences in removal from the wait list during the first 365 days due to death or deterioration was assessed with the use of Kaplan-Meier survival analysis. Patients were stratified according to listing before (era 1) or after (era 2) Food and Drug Administration approval of the Heartmate II LVAD on April 22, 2008. Freedom from death or deterioration on the wait list was higher for men than for women (70% vs 64%; P < .001). After adjusting for risk factors, women had a higher risk of removal from the wait list at 365 days during both era 1 (hazard ratio [HR] 1.23, 95% confidence interval [CI] 1.10-1.36; P < .001) and era 2 (HR 1.15, 95% CI 1.01-1.31; P = .029). Further adjustment for LVAD use eliminated the higher risk for women in era 2 (HR 1.14, 95% CI 0.99-1.29; P = .053) and not in era 1 (HR 1.22, 95% CI 1.10-1.36; P < .001)., Conclusions: The higher risk for death or deterioration in women waiting for HT has improved in the modern era., (Copyright © 2015 Elsevier Inc. All rights reserved.)

The prevalence of advanced heart failure (HF) is increasing because of the aging population and improvements in HF management strategies. Left ventricular assist device (LVAD) technology and management continue to advance rapidly, and it is anticipated that the number of LVAD implants will increase. LVADs have been demonstrated to extend life and improve outcomes in patients with advanced HF. The purpose of this article is to review and synthesize the evidence on impact of LVAD therapy on functional status. Significant functional gains were demonstrated in patients supported by LVAD throughout the 1st year, with most improvement in distance walked and peak oxygen consumption demonstrated in the 1st 6 months. Interventions to enhance exercise performance have had inconsistent effects on functional status. Poor exercise performance was associated with increased risk of adverse events. Functional status improved with LVAD therapy, although performance remained substantially reduced compared with age-adjusted norms. There is tremendous need to enhance our understanding of factors influencing functional outcomes in this high-risk population., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Background: Criteria for the identification of patients who may progress to advanced heart failure (HF) have been previously suggested. However, identification of appropriate non-inotrope-dependent (NID) patients for destination therapy (DT) remains a challenge, and referral rates are low. We surveyed expert provider opinion about patient selection for early DT., Methods: An internet-based survey was sent to international HF providers to investigate opinions about clinical indicators for referral of NID patients for DT. Subjects were identified from membership lists of HF professional organizations. Respondents provided their level of agreement with the use of a 5-point Likert Scale (1 = strongly disagree to 5 = strongly agree) to 10 clinical criteria describing at-risk NID patients., Results: A total of 231 respondents who had been in a position to recommend left ventricular assist device (LVAD) therapy for 7.6 ± 5.8 years identified themselves as HF providers: 41% HF cardiologists, 27% HF nurse practitioners, 21% cardiothoracic surgeons, 9% LVAD coordinators, and 2% general cardiologists. More than two-thirds of the respondents agreed or strongly agreed with 7 of the 10 items. Similar consensus was not seen for 6-minute walk (6MW) or B-type natriuretic peptide (BNP). When asked which criteria would have to be present for LVAD referral, only hemodynamic deterioration reached ≥50% affirmation among respondents. No criteria reached >50% response as being sufficient alone for DT., Conclusion: We describe referral thresholds for early LVAD therapy among international HF providers. With the exception of BNP and 6MW, we found overall agreement on the proposed clinical parameters. Despite apparent consensus, in practice implantation rates for LVAD in NID patients remain low. The results of ongoing clinical trials in this population may lower thresholds for early referral for DT., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Objectives: There have been no published recommendations about staffing needs for a heart failure (HF) clinic or an office setting focused on heart transplant. The goal of this survey was to understand the current staffing environment of HF, transplant, and mechanical circulatory support device (MCSD) programs in the United States and abroad. This report identifies current staffing patterns but does not endorse a particular staffing model., Methods: An online survey, jointly sponsored by the American College of Cardiology Foundation (ACCF), American Heart Association (AHA), and the Heart Failure Society of America (HFSA), was sent to the members of all 3 organizations who had identified themselves as interested in HF, heart transplant, or both, between March 12, 2009, and May 12, 2009., Results: The overall response rate to the 1,823 e-mail surveys was 23%. There were 257 unique practices in the United States (81% of total sites) and 58 international sites (19%); approximately 30% of centers were in a cardiovascular group practice and 30% in a medical school hospital setting. The large majority of practices delivered HF care in both an inpatient and outpatient environment, and slightly more centers were implanting MCSDs (47%) than performing cardiac transplantation (39%). Most practices (43%) were small, with <4 staff members, or small- to medium-sized (34%), with 4 to 10 staff members, with only 23% being medium (11-20 staff) or large programs (>20 staff). On average, a U.S. HF practice cared for 1,641 outpatients annually. An average HF program with transplant performed 10 transplants. Although larger programs were able to perform more transplants and see more outpatient HF visits, their clinician staffing volume tended to double for approximately every 500 to 700 additional HF visits annually. The average staffing utilization was 2.65 physician full-time equivalents (FTEs), 2.21 nonphysician practitioner (nurse practitioner or physician assistant) FTEs, and 2.61 nurse coordinator FTEs annually., Conclusions: The HF patient population is growing in number in the United States and internationally, and the clinicians who provide the highly skilled and time-consuming care to this population are under intense scrutiny as a result of focused quality improvement initiatives and reduced financial resources. Staffing guidelines should be developed to ensure that an adequate number of qualified professionals are hired for a given practice volume. These survey results are an initial step in developing such standards., (Copyright © 2011. Published by Elsevier Inc.)

Background: In patients with heart failure (HF) from left ventricular systolic dysfunction, the presence of coexistent right ventricular (RV) dysfunction is associated with poor exercise capacity and reduced survival. We sought to determine whether a simple measure of RV function, the RV myocardial performance index (RV MPI), is associated with adverse outcome in a population of advanced heart failure patients selected to receive cardiac resynchronization therapy (CRT)., Methods and Results: The RV MPI was measured on 77 consecutive preimplantation echocardiograms. The relationship between RV MPI and the end point of all-cause mortality, transplantation, or ventricular assist device placement was evaluated. The end point occurred in 28 patients (36%) during a median follow-up of 21 months. The median RV MPI was 0.73 (interquartile range 0.51-0.89). Worse RV function, as demonstrated by a higher RV MPI, was seen in those patients who reached the end point compared with those who did not (0.83 vs. 0.69, P = .004). The highest tercile of RV MPI was associated with a 3.3-fold increased risk of poor outcome (95% CI 1.3-8.5). Each 0.1 unit increase in RV MPI was associated with a 16% increased risk (95% CI 8-26). After adjusting for other echocardiographic variables, RV MPI remained significantly associated with the outcome., Conclusion: In a population of advanced HF patients selected to receive CRT, RV dysfunction, as assessed by the RV MPI, is associated with adverse outcome. Wider use of this simple nongeometric parameter may help to identify patients for whom options for further intervention should be carefully evaluated.