Electronic S3 Prediction of Hospital Readmissions for HF Exacerbation
Condition: Heart Failure; Heart Failure With Reduced Ejection Fraction; Heart Failure With Preserved Ejection Fraction
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      The study objective is to measure the value of the third heart sound (S3) for the prediction
      of recurrent heart failure (HF). For the purpose of this study, a heart failure event will be
      defined as a hospitalization with a primary diagnosis of heart failure. The main hypothesis
      of the study is that measurement of S3, using a microelectronic machine microphone positioned
      in a wearable device (Nanowear Wearable Congestive Heart Failure Management System) near the
      time of discharge from a hospitalization for heart failure, can predict which patients will
      be at high risk for a heart failure event, thereby identifying a group in whom increased
      surveillance and monitoring may decrease hospital readmissions for worsening heart failure.
    

Detailed description: 
      Heart failure (HF) is a complex clinical syndrome that results from any structural or
      functional impairment of the heart that affects the filling or ejection of blood in a cardiac
      cycle. HF manifests clinically as fatigue and dyspnea (shortness of breath). This may in turn
      result in exercise intolerance and fluid retention. Fluid retention leads to pulmonary
      congestion and/or peripheral edema [Yancy, 2017]. Cardiac rhythm abnormalities are very
      common among HF patients. Any new abnormalities that arise in a patient with fluid
      decompensation prolongs hospitalization as well as increases mortality rates [Lloyd-Jones,
      2010; Ross, 2009; Chaudhry, 2015].

      Within 5 years of a HF diagnosis, the mortality rate is 50%. The 30 day, 1-year and 5-year
      mortality rates after HF related hospitalization were 10.4%, 22 % and 42.3 % respectively.
      Post discharge mortality increased from 4.3% to 6.4% between 1993 and 2005 [Lloyd-Jones,
      2010; Ross, 2009]. In 2006, the number of deaths with a mention of HF was as high as it was
      in 1995. 1 out of every 9 mortalities in the US has HF mentioned as a cause. HF related
      deaths are approximately 7% of all cardiovascular diseases. In the US, HF related costs
      exceeded $30 billion in 2013. The average cost per patient for HF related hospitalization was
      $23,077. Hospitalization after a HF diagnosis happens at least once in 83% of the patients
      and up to four times in 43% of the patients [Yancy, 2017; Lloyd-Jones, 2010; Ross, 2009].

      Heart sounds, and particularly the third heart sound, are well known as specific a very
      specific clinical signs for heart failure and are associated with worse clinical outcomes. In
      the context of HF the presence of a pronounced or audible S3 is a specific sign of elevated
      filling pressures and is suggestive of a restrictive filling pattern with a steep transmitral
      E-wave [Siejko, 2017]. Recent advances in digital audio technology allow us to not simply
      assess for the presence or absence of a third heart in objective measures, but also allow us
      to quantitate it [Buck, 2017; Adamson, 2014; Lloyd, 2019]. Further, recent work has
      demonstrated that if a frequency range to detect and quantitate the third heart sound is used
      that extends below the usual range for human hearing, that the third heart sound may be even
      more predictive of clinical outcomes. The investigators are working with a device
      manufacturer who have a wearable diagnostic device that includes a directional
      microelectronic machine microphone that can effectively detect heart sounds. This device will
      be used to detect and quantitate heart sounds, and specifically the third heart sound, to
      investigate the prognostic implications of a third heart sound.
    

Intervention name(s): Measurement of S3 heart sound
Intervention type(s): Diagnostic Test
Intervention description(s): S3 heart sound to be measured by Nanowear Congestive Heart Failure Management System device.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients, 18 and older, admitted to the hospital with a primary diagnosis of acute heart
        failure and NYHA class II-IV at time of enrollment.
      
Keywords: Heart Failure