Intermacs Reporting FAQ

The “Cumulative” version of the Quality Assurance report includes Intermacs web-based data entry application data of all primary prospective patients implanted by your site thru the report coverage stop date for each quarter, as seen in the Quarterly Report Schedule above. Patient enrollment in Intermacs began on June 23, 2006 and retrospective entry of patients with implants after March 1, 2006 was allowed. Your institution may have joined Intermacs at a later date and therefore your patient enrollment may have begun at a later date. This report is restricted to your patients who were implanted after your enrollment date and received a primary implant.

The “Recent Year” version of the Quality Assurance report focuses on a contemporary cohort of patients. This report includes patients implanted in the most recent completed calendar year (2015) and any patients implanted in the current calendar year (2016).

Exclusion reasons from the QA report include:

• a. Retrospective patients (implanted prior to site activation)
• b. Patients whose first implant in Intermacs is not their primary implant
• c. Form Status = Incomplete and Pending
• d. Pediatric patients entered into Intermacs prior to the launch of Pedimacs
• e. Patient with missing Implant Dates
• f. If patients have had a previous cardiac operation (LVAD, RVAD, TAH)
• g. If patient has had a Clinical Event and Intervention this hospitalization (Pre-implant) (LVAD, RVAD, TAH)
• h. If patient has Interventions within 48 hours of implant (LVAD, RVAD, TAH)

RATE DEFINITION

Rates are a special type of comparison in which the ratio of two numbers is calculated. Rate are used when the ratio includes numbers with different units (example: miles per hour, or events per patient-months). In Intermacs the ratio is between the observed number of adverse events and the total amount of time patients have been supported on a device. A rate is not a percentage, it is a proportion obtained by dividing the number of events by the amount of patient follow-up time. This proportion can be scaled to compare the amount of events observed from groups that have different amounts of patient follow-up (example: your site and Intermacs overall).

CALCULATION

Adverse Event Rate (events per 100 patient months) = (number of events) / (patient time at risk (months)) * 100

EXAMPLE FROM 2015 Q3 QA REPORTS

Overall, Intermacs has followed 15,323 primary prospective patients for a total of 249,786 patient months at risk. The time at risk can be divided into early and late follow-up time using a three month cut point. Intermacs has a total of 41,189 months of early follow-up time and 208,597 months of late follow-up time. There were 8,138 early bleeding events (within 3 months of implant) and 6,820 late bleeding events (after 3 months of implant)

Early Bleeding Adverse Event Rate = 8,138 / 41,189 * 100 = 19.76

Late Bleeding Adverse Event Rate = 6,820 / 208,597 * 100 = 3.27

% with 30 day Readmission = (Patients with 30 day Readmission) / (Patients Discharged Alive on Device (n)) * 100

Patients Discharged Alive on Device (n) = number of patients discharged alive and on a device from a primary device implant hospitalization. This is the first hospitalization discharge recorded in Intermacs. A specific patient will have only one primary prospective implant hospitalization and will only be counted in this measure 1 time, even if they have subsequent implants after their initial hospitalization. If a patient has subsequent devices implanted during their first hospitalization in Intermacs and is discharged with a device in place they will be included.

Patients with 30 day Readmission = number of patients from the denominator that were rehospitalized for any reason within 30 days of the 1st time they were discharged alive with a device in place.

STS Intermacs has developed a process to field small scale custom analysis requests through a mechanism called a Minor Data Request (MDR). MDRs are formally submitted through the STS website and the analytics are performed by the STS Intermacs Data Coordinating Center (DCC). There are two types of MDRs:

1. Minor Data Requests for Quality Improvement
2. Minor Data Requests for Research purposes, most often used for the development of a formal research proposal

Note that MDR data is not intended for publication, and an MDR only allows for 4 hours of DCC analytic time. Follow this link for more information on formally submitting Minor Data Requests through STS.

Once the DCC receives a request, we are given 4 weeks to return it, but we can usually get it back much sooner.