Search

Tricuspid regurgitation (TR) is common in patients with end-stage heart failure receiving left ventricular assist devices (LVADs), but the benefit of concomitant tricuspid valve procedures (TVPs) remains uncertain. This study examined the impact of TVP at the time of LVAD implantation on clinical outcomes and quality of life (QOL) metrics. We included adult patients in the Interagency Registry for Mechanical Circulatory Support database with various degrees of TR who received continuous-flow LVADs from 2008 to 2017. Patients undergoing concomitant TVP were compared with those without the intervention in a stratified analysis. Descriptive analyses, survival analyses, and Andersen‒Gill hazard models were used as appropriate to examine associations with clinical and patient-centered QOL outcomes. Our analysis included 8,263 (53.1%) mild, 4,252 (33.3%) moderate, and 2,100 (13.5%) severe TR cases. TVP rate increased with severity: 8.6% of mild, 18.0% of moderate, and 43.9% of severe cases. TVP was not associated with survival benefit in cases of mild (adjusted hazard ratio [aHR]: 0.97, 95% CI: 0.79–1.19, p = 0.75), moderate (aHR: 1.03, 95% CI: 0.88–1.20, p = 0.72), or severe (aHR: 1.20, 95% CI: 0.98–1.48, p = 0.08) TR. For patients with combined moderate or severe TR, TVP was associated with increased mortality (log-rank p < 0.01, aHR: 1.13, 95% CI: 1.00–1.27, p = 0.04). After adjusting for TR severity, TVP was associated with increased risk of bleeding, arrhythmia, and stroke (p < 0.01 each) and no improvements in QOL (p > 0.05). TVP at the time of LVAD implantation was not associated with either improved survival or QOL, and there were associations with increased risk of adverse events among patients with moderate and severe TR. [ABSTRACT FROM AUTHOR]

Importance: Patient outcomes in heart failure clinical trials are generally better than those observed in real-world settings. This may be related to stricter inclusion and exclusion criteria in clinical trials. Objective: We study sought to characterize the clinical implications of differences between patients in clinical trials and those in a real-world registry of patients receiving left ventricular assist devices (LVADs). Design, setting, and participants: This retrospective cohort study included all patients in INTERMACS (the Interagency Registry for Mechanically Assisted Circulatory Support) who were implanted with an axial flow LVAD from 2010 to 2015 to allow for equivalent comparisons. Main outcomes and measures: Differences in patient characteristics and 2-year rates of adverse outcomes with those reported in the ENDURANCE and MOMENTUM 3 clinical trials. Survival analyses were used to assess the relationships between prespecified patient factors and clinical outcomes. Results: Of the 10,937 LVAD recipients identified in INTERMACS between 2010–2015, 44% met at least 1 clinical trial exclusion criterion. The 2-year incidence of stroke and death amongst LVAD recipients in INTERMACS and the landmark clinical trials differed significantly (P<0.04, both). Nevertheless, patients who would have been excluded from the clinical trials did not have dramatically different 2-year mortality outcomes in INTERMACS [2y survival estimate: 66.4%, 95% CI (64.9–67.9%) versus 71.9%, 95% CI (70.6–73.1%)]. Clinical interventions driving a significantly increased risk of death were relatively rare (<5% of implants) and included mechanical ventilation, ECMO, severe thrombocytopenia, and dialysis. Conclusions and relevance: Most exclusion criteria used in LVAD clinical trials did not afford a substantially greater risk to patients in the real-world setting. In the relatively infrequent cases of end stage renal disease, thrombocytopenia, respiratory failure, and need for ECMO, the risks and benefits of LVAD therapy need careful weighting and further study. [ABSTRACT FROM AUTHOR]

BACKGROUND Age is known to be associated with the prevalence and pathophysiology of hypertension. However, there is little information on whether age stands as a good proxy for the specific hemodynamic profile of an individual with elevated blood pressure (BP), which could be important in the selection of therapy. DESIGN This is a cross‐sectional study. SETTING People who underwent a noninvasive, hemodynamic assessment using impedance cardiography at 51 sites of iKang Health Checkup Centers throughout China between January 2012 and October 2018. PARTICIPANTS We included 116,851 individuals, aged 20 to 80 years. MAIN OUTCOMES AND MEASURES Relationship between age and hemodynamic parameters (cardiac index, systemic vascular resistance index [SVRI]), among individuals with elevated BP (systolic BP ≥130 mm Hg or diastolic BP ≥80 mm Hg). RESULTS: Final study population included 45,082 individuals with elevated BP: 29,194 men and 15,888 women with a mean (±SD) age of 48 (±13) and 54 (±12) years, respectively. Cardiac index was negatively associated with age with an adjusted, per decade decrease of 0.17 (95% confidence interval [CI] = 0.17‐0.18) L/min/m2 in men and 0.24 (95% CI = 0.23‐0.25) L/min/m2 in women. SVRI was positively associated with age with an adjusted, per‐decade increase of 174.2 (95% CI = 168.8‐179.7) dynes·s·cm−5·m2 in men and 214.1 (95% CI = 204.3‐223.8) dynes·s·cm−5·m2 in women. However, there was substantial overlap in the distribution of these parameters across different age groups in both sexes. CONCLUSIONS: In this large study, we observed that cardiac index decreased and SVRI increased with age among individuals with elevated BP. Even though there was a general trend with age, we observed heterogeneity within age strata, suggesting that age alone is inadequate to indicate the hemodynamic profile for an individual. J Am Geriatr Soc 68:1520‐1528, 2020. [ABSTRACT FROM AUTHOR]