The Effect of Iodinated Contrast Media Sensitivity on the Prognosis of Patients with STEMI.

Background and Objectives: Iodinated Contrast Media (ICM) is used daily in many imaging departments worldwide. The main risk associated with ICM is hypersensitivity. When a severe hypersensitivity reaction is not properly managed and treated swiftly, it may be fatal. Currently, there is no data to demonstrate how ICM sensitivity affects the prognosis of cardiac patients, especially those diagnosed with ST elevation myocardial infarction (STEMI), in whom urgent coronary angiography is indicated. This study aimed to identify and characterize this relationship. Materials and Methods: We included patients hospitalized with STEMI between 2016 and 2019 from the National Inpatient Sample. The population was compared based on ICM sensitivity status, sensitive vs. non-sensitive. The primary endpoint was in-hospital mortality, with additional endpoints: length of stay and in-hospital complications. Results: The study included 664,620 STEMI patients, of whom 4905 (0.7%) were diagnosed with ICM sensitivity. ICM-sensitive patients were older, more often white, females, and had more comorbidities and cardiovascular risk factors. Both groups show similarities in management but are slightly less probable to undergo PCI or CABG. Multivariable logistic regression models found that the ICM-sensitive population had similar odds of in-hospital mortality (OR: 1.02, 95% CI: 0.89-1.16) and MACCE (OR: 1.05, 95% CI: 0.95-1.16), and less major bleeding (OR: 0.73, 95% CI: 0.60-0.87). Conclusions: Our study found that ICM sensitivity status was not a significant factor for worse prognosis in patients hospitalized with STEMI.

The Effects of Preoperative Pain Education on Pain Severity in Cardiac Surgery Patients: A Pilot Randomized Control Trial.

BACKGROUND: There is minimal research on the effect of individualized preoperative education on postoperative pain and postoperative pain medication intake. AIM: The study objective was to assess the effect of individually tailored preoperative education on postoperative pain severity, number of pain breakthroughs, and use of pain medication in participants receiving the intervention compared to controls. METHODS: A pilot study with 200 participants was conducted. The experimental group received an informational booklet and discussed their ideas surrounding pain and pain medication with the researcher. Controls received no intervention. Postoperative pain severity was measured by a Numerical Rating System (NRS), which was divided into mild (NRS 1-3), moderate (NRS 4-6), and severe (NRS 7-10). RESULTS: In the participant cohort, 68.8% of participants were male, and the average age was 60.48±10.7. Average postoperative 48-hour cumulative pain scores were lower in those who received the intervention compared to controls; 50.0 (IQR 35.8-60.0) vs. 65 (IQR 51.0-73.0; p < .01) participants who received the intervention had less frequent pain breakthroughs when compared to controls (3.0 [IQR 2.0-5.0] vs. 6.0 [IQR 4.0-8.0; p < .01]). There was no significant difference in the amount of pain medication taken by either group. CONCLUSIONS: Participants who receive individualized preoperative pain education are more likely to have decreased postoperative pain.

The Prognostic Value of Cardiovascular Risk Factors and Laboratory Biomarkers in Predicting 6-Month Outcomes in High-risk Patients with Non-ST Segment Elevation Myocardial Infarction.

BACKGROUND: Acute coronary syndrome (ACS) represents a spectrum of ischemic myocardial disease including unstable angina (UA), non-ST-segment elevation myocardial infarction (NSTEMI), and ST-elevation myocardial infarction (STEMI). Various prognostic scores were developed for patients presenting with NSTEMI-ACS. Among these scores, the GRACE risk score offers the best discriminative performance for prediction of in-hospital and 6-month mortality. However, the GRACE score is limited and cannot be used in several ethnic populations. Moreover, it is not predictive of clinical outcomes other than mortality. OBJECTIVES: To assess the prognostic value of traditional cardiovascular risk factors and laboratory biomarkers in predicting 6-month major adverse cardiac and cerebrovascular events (MACCE), including hospitalization, recurrent percutaneous coronary intervention (PCI), stroke, and cardiovascular mortality in patients with NSTEMI treated with PCI. METHODS: This retrospective study included consecutive patients admitted with an initial diagnosis of NSTEMI to the cardiac intensive care unit (CICU) at the Tzafon Medical Center, Israel, between April 2015 and August 2018 and treated by PCI within 48 hours of admission. RESULTS: A total of 223 consecutive patients with NSTEMI treated by PCI were included in the study. Logarithmebrain natriuretic peptide (LogₑBNP), prior MI, and Hb levels were found to be significant predictors of any first MACCE. Only logₑBNP was found to be an independent predictor of a first MACCE event by multivariate logistic regression analysis. CONCLUSIONS: LogₑBNP is an independent predictor of worse prognosis in patients with NSTEMI. Routine evaluation of BNP levels should be considered in patients admitted with NSTEMI.

Sex Differences in Left Ventricular Assist Device-related Emergency Department Encounters in the United States.

BACKGROUND: There is a paucity of data regarding sex differences in the profiles and outcomes of ambulatory patients on left ventricular assist device (LVAD) support who present to the emergency department (ED). METHODS AND RESULTS: We performed a retrospective analysis of 57,200 LVAD-related ED patient encounters from the 2010 to 2018 Nationwide Emergency Department Sample. International Classification of Diseases Clinical Modification, Ninth Revision and Tenth Revision, codes identified patients aged 18 years or older with LVADs and associated primary and comorbidity diagnoses. Clinical characteristics and outcomes were stratified by sex and compared. Multivariable logistic regression was used to evaluate predictors of hospital admission and death. Female patient encounters comprised 27.2% of ED visits and occurred at younger ages and more frequently with obesity and depression (all P < .01). There were no sex differences in presentation for device complication, stroke, infection, or heart failure (all P > .05); however, female patient encounters were more often respiratory- and genitourinary or gynecological related (both P < .01). After adjustment for age group, diabetes, depression, and hypertension, male patient encounters had a 38% increased odds of hospital admission (95% confidence interval 1.20-1.58), but there was no sex difference in the adjusted odds of death (odds ratio 1.11, 95% confidence interval 0.86-1.45). CONCLUSIONS: Patient encounters of females on LVAD support have significantly different comorbidities and outcomes compared with males. Further inquiry into these sex differences is imperative to improve long-term outcomes.

Clinical factors and pre-surgical depression scores predict pain intensity in cardiac surgery patients.

BACKGROUND: Severe pain is prevalent in cardiac surgery patients and can increase cardiac complications, morbidity and mortality. The objectives of the study were to assess perioperative pain intensity and to assess predictors of pain post-cardiac surgery, including clinical characteristics and depression. METHODS: A total of 98 cardiac surgery patients were included in the study. Pain intensity was assessed using a Numerical Rating System. Pain was measured one day pre-operatively and recorded daily from Post-operative Day 2 to Day 7. Clinical data were recorded and depression scores were assessed using the Center for Epidemiological Study of Depression (CES-D). RESULTS: Pain intensity increased significantly during hospitalization from pre-operative levels, surging at 2 days post-operatively. Predictors of high pain intensity were high pre-operative CES-D scores, female gender, cardiac function, smoking and high body mass index (BMI). Significantly higher pre-operative CES-D scores were found in patients with severe pain compared to patients with no pain to moderate pain (18.23 ± 1.80 vs 12.84 ± 1.22, p = 0.01 pre-operatively). Patients with severe pain (NRS 7-10) had significantly higher levels of white blood cells (WBC) compared to patients with no pain-moderate pain (NRS 0-6), (p = 0.01). However, CES-D scores were only weakly correlated maximum WBC levels perioperatively. CONCLUSION: Pain intensity significantly increased following surgery, and was associated with depressive symptoms, female sex, cardiac function, BMI, and smoking. These factors may serve as a basis for identification and intervention to help prevent the transition from acute pain to chronic pain.

Mental health disorders and emergency resource use and outcomes in ventricular assist device supported patients.

There are limited data describing the prevalence of mental health disorders (MHDOs) in patients with ventricular assist devices (VADs), or associations between MHDOs and resource use or outcomes. We used the Nationwide Emergency Department Sample administrative database to analyze 44,041 ED encounters for VAD-supported adults from 2010 to 2017, to assess the relationship between MHDOs and outcomes in this population. MHDO diagnoses were present for 23% of encounters, and were associated with higher charges and rates of admission, but lower mortality.

Impact of Socioeconomic Status on Outcomes After Ventricular Assist Device Implantation Using the Area Deprivation Index.

BACKGROUND: This study evaluates the Area Deprivation Index (ADI) as a novel prognostic metric of socioeconomic status for patients with a left ventricular assist device. METHODS AND RESULTS: A retrospective analysis of patients with a left ventricular assist device at a high-volume institution from 2007 to 2018 was conducted. Socioeconomic status was determined using the ADI, a multifactorial neighborhood-based metric where higher ADI denotes worse socioeconomic status. Patients were stratified into 4 ADI cohorts. Long-term survival was compared with multivariate analysis. Of the 380 patients stratified by ADI, 35 were in the 10th percentile or lower, 218 were in the 11th-50th percentile, 104 were in the 51st-89th percentile, and 23 were in the 90th percentile or higher. Baseline characteristics were comparable. On multivariate analysis, being male (hazard ratio [HR], 0.14; P = .01), bridge-to-transplant (HR, 0.14; P = .03), and not requiring biventricular support (HR, 0.02; P < .01) were protective, whereas chronic kidney disease (HR, 9.07; P < .01) and an elevated total bilirubin (HR, 3.56; P = .02) were harmful. The ADI as a continuous variable did not affect survival; however, categorically, a higher ADI was protective (ADI 90-100: HR, 0.07; P = .04). CONCLUSIONS: Socioeconomically disadvantaged patients had noninferior outcomes given appropriate pre-implant optimization and workup.

Heart transplant waiting list implications of increased ventricular assist device use as a bridge strategy: A national analysis.

The use of ventricular assist devices (VADs) as a bridge to heart transplant (HT) is increasing, while HT volume remains stagnant. This may portend longer waiting times and an otherwise more competitive environment for all patients on the HT waiting list. A retrospective analysis of patients who were listed for HT in the United Network for Organ Sharing (UNOS) database from 2000 to 2015 was conducted. Mean waiting time, proportion of HT reception (%HT), proportion of death (%death), and proportion of waiting list removal (%removal) were calculated across three eras: Era 1 (2000-2007), Era 2 (2008-2011), and Era 3 (2012-2015). During the study period, 29 728 patients successfully underwent HT. 19 127 (64.3%) were directly transplanted (direct HT); 4491 (15.1%) received VADs prior to listing as a bridge to decision (BTD); and 4593 (15.5%) received VADs after listing as a bridge to transplant (BTT). Across the three eras, the average number of registrants per year grew. Among all groups, waiting time increased across the eras. %HT generally decreased in the BTD and BTT groups but remained constant in the direct HT group. %removal increased, while %death decreased in all group across the eras. Waiting time for HT increased from 2000 to 2015. Patients with VADs as a bridge strategy experienced decreasing %HT and increasing %removal but stable survival. Improvements in VAD safety and durability will ensure their success as part of a bridge strategy to HT under the new UNOS allocation policy.

Health-Related Quality of Life in Patients With a Left Ventricular Assist Device (QOLVAD) Questionnaire: Initial Psychometrics of a New Instrument.

BACKGROUND: Patients with a left ventricular assist device are a unique and growing population who deserve their own valid, reliable instrument for health-related quality of life. OBJECTIVE: We developed and tested the Health-Related Quality of Life with a Left Ventricular Assist Device (QOLVAD) questionnaire. METHODS: In a prospective, descriptive study, patients from 7 sites completed the QOLVAD and comparator questionnaires. Construct validity was tested using confirmatory factor analysis. Convergent validity was tested using correlations of QOLVAD scores to well-established measures of subjective health status, depression, anxiety, and meaning/faith. Reliability and test-retest reliability were quantified. RESULTS: Patients (n = 213) were 58.7 ± 13.9 years old; 81.0% were male, 73.7% were White, and 48.0% had bridge to transplant. Questionnaires were completed at a median time of 44 weeks post ventricular assist device. The 5 QOLVAD domains had acceptable construct validity (root mean square error of approximation = 0.064, comparative and Tucker-Lewis fit indices > 0.90, weighted root mean square residual = 0.95). The total score and domain-specific scores were significantly correlated with the instruments to which they were compared. Internal consistency reliability was acceptable for all subscales (α = .79-.83) except the cognitive domain (α = .66). Unidimensional reliability for the total score was acceptable (α = .93), as was factor determinacy for multidimensional reliability (0.95). Total test-retest reliability was 0.875 (P < .001). CONCLUSION: Our analysis provided initial support for validity and reliability of the QOLVAD for total score, physical, emotional, social, and meaning/spiritual domains. The QOLVAD has potential in research and clinical settings to guide decision making and referrals; further studies are needed.

Relationship Between Change in Heart Transplant Volume and Outcomes: A National Analysis.

INTRODUCTION: Although volume-outcome relationships in transplantation have been well-defined, the effects of large changes in center volume are less well understood. The purpose of the current study was to examine the impact of changes in center volume on outcomes after heart transplantation. METHODS: Retrospective analysis was performed of adult patients undergoing heart transplant between 2000 and 2017 identified in the United Network for Organ Sharing database. Exclusions included annual volume <10. Patients were grouped according to percentage change in center volume from the previous year. Multivariable Cox regression models were adjusted for the significant preoperative variance identified on univariate analyses. RESULTS: Of the 29,851 transplants during the study period, 64% were at centers with stable volume (±25% annual change), whereas 10% were performed at contracting (-25% change or more) and 26% were performed at growing (+25% change or more) centers. Average volume was lower with contracting centers compared with stable or growing programs (21 vs 36, P< .001). Thirty-day mortality was greater in decreasing centers (6% vs 4%, P < .001), with more acute rejection treatments at 1y (27% vs 24% P < .001). The adjusted risk of mortality among contracting centers was 1.25 ([1.07-1.46], P= .004), whereas growing centers had unaffected risk (0.90 [0.79-1.02], P= .103). Causes of death were similar between groups. CONCLUSIONS: Rapid growth of transplant center volume has occurred at select centers in the United States without decrement in programmatic outcomes. Decreasing center volume has been associated with poorer outcomes, although the causative nature of this relationship requires further investigation.

Treatment With Impella Increases the Risk of De Novo Aortic Insufficiency Post Left Ventricular Assist Device Implant.

BACKGROUND: Impella (Abiomed Inc, Danvers, MA) is a temporary mechanical support device positioned across the aortic valve, and can be used to support patient before LVAD implantation. There are no data on the incidence of aortic insufficiency (AI) in patients supported with Impella as a bridge to durable LVAD implantation. We sought to assess the incidence of AI in patients with Impella support as a bridge to durable left ventricular assist device (LVAD) implantation. METHODS: We reviewed all patients undergoing primary LVAD implantation at the University of Pennsylvania from January 2015 onward, comparing those supported with Impella as temporary mechanical support with those supported by either venoarterial extracorporeal life support or an intra-aortic balloon pump. We reviewed transthoracic echocardiography preoperatively, as well as at 1 week, 1, 3, 6, 9, and 12 months after LVAD implantation. RESULTS: A total of 215 echocardiograms were analyzed in 41 patients. Eleven patients were supported with Impella before LVAD implant-6 patients with Impella alone (5 with Impella CP, 1 with Impella 5.0) and 5 with Impella in conjunction with venoarterial extracorporeal life support (2 with Impella 2.5, 2 with Impella CP, and 1 with Impella 5.0). After LVAD implant, mild or moderate AI developed in 82% of patients supported with Impella (9 of 11) compared with 43% of those without Impella (13 of 30) (P = .038). CONCLUSIONS: Patients supported by Impella as a bridge to durable LVAD have a higher risk of developing AI. Further studies are needed to assess this risk as the use of the Impella increases.

Transcatheter aortic valve replacement thrombosis in patient supported with durable left ventricular assist device.

Aortic insufficiency (AI) is a frequent problem after continuous-flow left ventricular assist device (LVAD) implantation and results in increased morbidity and mortality. Advances in transcatheter aortic valve replacement (TAVR) technology have resulted in this being discussed as a potential option for LVAD patients with AI. While small case series have been published, we report the first case of TAVR thrombosis in an LVAD patient. This case highlights a major diagnostic and management dilemma that should become more present if this strategy becomes more widespread.

Cardiac Contractility Monitoring: an Important Therapy in the Treatment of Advanced Heart Failure.

PURPOSE OF REVIEW: This review highlights the mechanisms of action of cardiac contractility modulation (CCM) and the clinical data which supports its use for the appropriate patient population. RECENT FINDINGS: CCM has beneficial effects on myocardial calcium handling and reverse remodeling of abnormal genetic programs. Clinical trials show sustained improvements in quality of life, exercise tolerance, and heart failure symptoms. Heart failure is a global epidemic that is expected to increase in prevalence over the coming years. Despite improvements in, and the standardization of, optimal medical therapy (OMT), morbidity and mortality remain unacceptably high, with a 5-year mortality rate of 50%. While more recent advances in device therapies, including chronic resynchronization therapy (CRT), and left ventricular assist devices (LVADs), have changed the care of advanced heart failure for a certain subset of patients, there remains a therapeutic gap in the treatment of patients with heart failure and reduced ejection fraction (HFrEF) who are not candidates for CRT. CCM is a novel device-based therapy which delivers an electrical stimulus during the absolute refractory period and has been shown to improve heart failure symptoms, exercise tolerance, and quality of life.

Correction to: Cardiac Contractility Modulation: an Important Therapy in the Treatment of Advanced Heart Failure.

The article title in the original publication contains a mistake.

Left Ventricular Assist Device as Destination Therapy: a State of the Science and Art of Long-Term Mechanical Circulatory Support.

PURPOSE OF REVIEW: The purpose of this review is to synthesize and summarize recent developments in the care of patients with end-stage heart failure being managed with a left ventricular assist device (LVAD) as destination therapy. RECENT FINDINGS: Although the survival of patients treated with LVAD continues to improve, the rates of LVAD-associated complication, such as right ventricular failure, bleeding complications, and major infection, remain high, and management of these patients remains challenging. The durability and hemocompatibility of LVAD support have greatly increased in recent years as a result of new technologies and novel management strategies. Challenges remain in the comprehensive care of patients with destination therapy LVADs, including management of comorbidities and optimizing patient function and quality of life.

Pulmonary Hypertension in Advanced Heart Failure: Assessment and Management of the Failing RV and LV.

PURPOSE OF REVIEW: In patients with heart failure with reduced ejection fraction, the presence of pulmonary hypertension (PH-LHD) has a significant impact on their prognosis. The purpose of this review is to explain the methods of diagnosing PH-LHD and then discuss the available therapeutic options. RECENT FINDINGS: We begin by examining the methods of assessment of PH-LHD-echocardiography, cardiopulmonary exercise testing, and right heart catheterization-with a particular focus on the importance of accurate measurement to ensure the proper determination of PH-LHD. We then focus primarily on management of PH-LHD, with an examination of trials of therapeutic options, use of mechanical circulatory support, and transplantation. This review highlights the complexities in diagnosis and management of PH-LHD. We outline a number of useful ways to maximize the yield of diagnostic testing, as well as give suggestions on the use of medical therapies, the role of both temporary mechanical support and left ventricular assist device, and finally the ways to best bridge these patients to transplantation.

Determinants of Diuretic Responsiveness and Associated Outcomes During Acute Heart Failure Hospitalization: An Analysis From the NHLBI Heart Failure Network Clinical Trials.

BACKGROUND: Poor response to loop diuretic therapy is a marker of risk during heart failure hospitalization. We sought to describe baseline determinants of diuretic response and to further explore the relationship between this response and clinical outcomes. METHODS AND RESULTS: Patient data from the National Heart, Lung, and Blood Institute Heart Failure Network ROSE-AHF and CARRESS-HF clinical trials were analyzed to determine baseline determinants of diuretic response. Diuretic efficiency (DE) was defined as total 72-hour fluid output per total equivalent loop diuretic dose. Data from DOSE-AHF was then used to determine if these predictors of DE correlated with response to a high- versus low-dose diuretic strategy. At 72 hours, the high-DE group had median fluid output of 9071 ml (interquartile range: 7240-11775) with median furosemide dose of 320 mg (220-480) compared with 8030 ml (6300-9915) and 840 mg (600-1215) respectively for the low DE group. Cystatin C was independently associated with DE (odds ratio 0.36 per 1mg/L increase; 95% confidence interval: 0.24-0.56; P < 0.001). Independently from baseline characteristics, reduced fluid output, weight loss and DE were each associated with increased 60 day mortality. Among patients with estimated glomerular filtration rate below the median, those randomized to a high-dose strategy had improved symptoms compared with those randomized to a low-dose strategy. CONCLUSIONS: Elevated baseline cystatin C, as a biomarker of renal dysfunction, is associated with reduced diuretic response during heart failure hospitalization. Higher loop diuretic doses are required for therapeutic decongestion in patients with renal insufficiency. Poor response identifies a high-risk population.