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Severe tricuspid regurgitation (TR) remains a vastly undertreated disease, with sustained elevation of right atrial (RA) pressure directly resulting in chronic end-organ damage. Recently, bi-caval valve implantation has been shown to improve symptoms in patients with symptomatic TR who are at high risk for surgery. We present the first report of intermediate term hemodynamic effects of single inferior vena cava (IVC) valve implantation (CAVI) for treatment of severe TR. We performed CAVI on a 66-year-old female with severe TR, who suffered from repeat hospitalizations for treatment refractory NYHA class III-IV heart failure symptoms and had prohibitive operative risk. Pre-implantation right heart catheterization (RHC) revealed a mean RA pressure of 12 mm Hg, an IVC mean pressure of 13 mm Hg, with V-waves to 16 and 18 mm Hg in the RA and IVC respectively, and a cardiac output (CO) of 3.5 liters per minute (LPM). Postprocedure, mean IVC and RA pressures decreased to 11 and 10 mm Hg, respectively, with CO increasing to 5.1 LPM. At one month, symptoms improved to NYHA class II. At 9 months, mean RA pressure was 5 mm Hg with V-waves to 7 mm Hg and an improvement in CO to 6.3 LPM. CAVI appears to result in similar decreases in RA pressure at intermediate follow-up as compared to bi-caval valve implantation. The favorable hemodynamic effects were likely mediated by redirection of regurgitant blood flow away from the IVC thereby resulting in sustained reduction in right-sided pressures as well as an increase in CO. © 2017 Wiley Periodicals, Inc.

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Background: There is a need for simple, noninvasive solutions to remotely monitor and predict worsening heart failure (HF) events. SCALE-HF 1 (Surveillance and Alert-Based Multiparameter Monitoring to Reduce Worsening Heart Failure Events) is a prospective, multicenter study that will develop and assess the accuracy of the heart function index—a composite algorithm of noninvasive hemodynamic biomarkers from a cardiac scale—in predicting worsening HF events. Methods: Approximately 300 patients with chronic HF and recent decompensation will be enrolled in this observational study for model development. Patients will be encouraged to take daily cardiac scale measurements. Results: Approximately 50 HF events, defined as an urgent, unscheduled clinic, emergency department, or hospitalization for worsening HF will be used for model development. The composite index will be developed from hemodynamic biomarkers derived from ECG, ballistocardiogram, and impedance plethysmogram signals measured from the cardiac scale. Biomarkers of interest include weight, peripheral impedance, pulse rate and variability, and estimates of stroke volume, cardiac output, and blood pressure captured through the cardiac scale. The sensitivity, unexplained alert rate, and alerting time of the index in predicting worsening HF events will be evaluated and compared with the performance of simple weight-based rule-of-thumb algorithms (eg, weight increase of 3 lbs in 1 day or 5 lbs in 7 days) that are often used in practice. Conclusions: SCALE-HF 1 is the first study to develop and evaluate the performance of a composite index derived from noninvasive hemodynamic biomarkers measured from a cardiac scale in predicting worsening HF events. Subsequent studies will validate the heart function index and assess its ability to improve patient outcomes. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04882449.