The New York Heart Association
(NYHA) functional classification provides an additional means of assessing heart failure severity to guide treatment and monitor patient response.
In the study, before, 30 and 90 days after the procedure, patients were assessed for the severity of their heart failure (stage 1-4), based on standard New York Heart Association
Study subjects must be diagnosed with New York Heart Association
(NYHA) Class II or III heart failure as a result of a previous heart attack.
Trial endpoints include positive effects on volume reduction, ejection fraction, quality of life, New York Heart Association
Class, 6 minute walk test, and rehospitalisation.
The study also showed significant improvements in quality of life at one year which were sustained through four years, with 74 percent of patients improving at least one New York Heart Association
(NYHA) functional class from baseline to four years.
REVERSE included 610 patients with New York Heart Association
(NYHA) class I of II heart failure, a QRS interval of 120 milliseconds or more, and a left ventricular ejection fraction of 40% or less, all of whom were on optimal medical therapy.
The pioglitazone label has a boxed warning stating that treatment with TZDs, including pioglitazone, can cause or exacerbate heart failure, and that patients on treatment with pioglitazone should be monitored closely for heart failure; it is contraindicated in patients with New York Heart Association
(NYHA) III or IV heart failure.
The remaining 9 patients showed significant improvement in mean left ventricular ejection fraction and in Modified New York Heart Association
functional class, which enabled them to be removed from the heart transplant waiting list.
The CardioMEMS HF System is the first and only FDA-approved heart failure monitor that, when used by physicians, has been shown to significantly reduce heart failure hospital admissions and improve the quality of life in New York Heart Association
Class III patients.
While the patients were at high risk of deteriorating heart function based on their initial cardiac MRI, there was a statistically significant and clinically meaningful improvement at twelve month follow-up in New York Heart Association