Total daily readings divided by total number possible for daily readings as well as total weekly readings divided by total possible weekly readings

To assess the effectiveness of the training program, the safety and effectiveness results were analyzed for Academic Hospitals versus Community Hospitals.

To assess the effectiveness of the training program, the safety and effectiveness results were analyzed for Academic Hospitals versus Community Hospitals.

To assess the effectiveness of the training program, the safety and effectiveness results were analyzed for Academic Hospitals versus Community Hospitals.

A Sensor failure occurs when no readings can be obtained from it after troubleshooting the system to rule out any problems with the external electronics. The primary safety analyses were based on the following objective performance criteria: a) the lower limit of the two-sided 95% confidence interval on the freedom from DSRC rate at 24 months is greater than 80% and b) the lower limit of the two-sided 95% confidence interval on the freedom from pressure sensor failure rate at 24 months is greater than 90%. These primary safety endpoints were tested hierarchically, testing for freedom from DSRCs first, in order to control for multiplicity.

Subjects implanted with CardioMEMS device

Annualized HFH rate parameter at 1 year versus the HFH rate in the year prior to enrollment using an Andersen-Gill method for recurrent events and robust sandwich variances to account for within-subject correlation. If the two-sided, upper 95% confidence interval for the hazard ratio (HR) is less than 1.0, then the primary effectiveness endpoint was met.

Patients implanted with a CardioMEMS PA Sensor

Survival at 1 year and 24 years post-implant is reported using the Kaplan-Meier method.

The annualized HFH or death rate parameter at 1 year was compared to the HFH rate in the year prior to enrollment using an Andersen-Gill method for recurrent events and robust sandwich variances to account for within-subject correlation. If the two-sided, upper 95% confidence interval for the hazard ratio (HR) is less than 1.0, then this effectiveness endpoint was met.

Total daily readings divided by total number possible for daily readings as well as total weekly readings divided by total possible weekly readings

To assess the effectiveness of the training program, the safety and effectiveness results were analyzed for Academic Hospitals versus Community Hospitals.

To assess the effectiveness of the training program, the safety and effectiveness results were analyzed for Academic Hospitals versus Community Hospitals.

To assess the effectiveness of the training program, the safety and effectiveness results were analyzed for Academic Hospitals versus Community Hospitals.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.

Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.