Heart failure is a disease with high morbidity and mortality in the U.S. and globally. There are about 5.7 million people in the U.S with heart failure, and about 10 million in Europe. The disease is present more frequently in patients over 65 years old. Data from the ongoing Framingham Heart Study has shown that the one-year mortality rate is 22% and the 5-year mortality rate is 42%. While there have been significant advancements in the care of patients with heart failure, there is still no cure. In addition, Medicare has estimated that the number one cause for hospital admissions in the U.S. is heart failure, according to ICD-9 and ICD-10 reimbursement codes.
The CardioMEMS™ Heart Failure System is the first implantable device in the U.S. that has shown to decrease the number of HF-related hospital readmissions in patients implanted with the sensor and reported in the original CHAMPION trial. This study focused upon the evaluation of HF patients’ perception of quality of life and whether there was a statistically significant decrease in the number of HF-related hospital readmissions among those implanted with the CardioMEMS™ sensor.
This study was conducted in three phases: one qualitative and two quantitative phases. The qualitative aspect included individual interviews with NYHA Class III HF patients who had the CardioMEMS™ sensor implanted.
Qualitative study findings revealed that patients with HF experienced fatigue that impacted their activities of daily living, particularly those involving family. It also revealed that despite the fact that none of the respondents had been hospitalized for a HF-related reason, most did not perceive an improvement in their quality of life since implantation of the CardioMEMS™ sensor based on individual participant interviews.
The first quantitative aspect of the study assessed the perception of quality of life of these same patients based upon individual MLFHQ scores. Findings from MLHFQ results revealed that there was a negative impact in respondents’ quality of life, particularly in the physical dimensions of the MLHFQ. Interestingly, those scores were somewhat lower than what is found in the literature.
The second of the quantitative phase analyzed the number of HF-related hospital admissions in patients with the CardioMEMS™ sensor based on a 1:28 retrospective case-control matching study design. Analysis showed that patients implanted with the CardioMEMS™ sensor had a statistically significant decrease in the number of HF-related hospital admissions. Incidental findings also showed a statistically significant decrease in the number of HF-related hospital readmissions in patients with NYHA Class III HF after implantation of the CardioMEMS™. This is compelling evidence of the need for further studies in this new technology and its impact on patients with NYHA Class III HF.
|Commitee:||Continelli, Tracey, Kelman, Glenda|
|School:||Sage Graduate School|
|Department:||School of Health Sciences|
|School Location:||United States -- New York|
|Source:||DAI-B 80/03(E), Dissertation Abstracts International|
|Keywords:||Cardiomems, Heart failure, Hospital readmissions, NYHA classification, Quality of life, Telemonitoring|
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