Data Access NOTE: Please refer to the “Authorized Access” section below for information about how access to the data from this accession differs from many other dbGaP accessions. Available Data Data available for request include Intermacs and Pedimacs data, as well as data from the Medical Arm of Mechanical Circulatory Support (MedaMACS) Study. Follow-up data through December 31, 2017 are available.Objectives The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) is a North American registry of data for adults who received an FDA approved mechanical circulatory support device (MCSD) due to advanced heart failure. The overarching goal of Intermacs is to advance the understanding and application of mechanical circulatory support devices (MCSD) in order to improve the duration and quality of life of individuals with advanced heart failure. Similarly, the Pedimacs registry shares the same quality improvement goals but for pediatric MCSD recipients.Background Outcomes for individuals with advanced heart failure are typically poor, especially for those whose health cannot be reversed without a transplant or MCSD. Those who receive a MCSD may have prolonged longevity and a better quality of life but there was little documentation as to the best practices for MCSD implantation and follow up care. The Intermacs database, which began in 2006, became part of the Society of Thoracic Surgeons (STS) National database in 2018, is an interagency collaborative attempt to collect information about MCSD recipients for reasons of quality improvement. The Pedimacs registry was initiated in 2012 and also has transitioned under the STS in 2018.Participants There were 22671 participants enrolled.Design At the time the data were locked and provided to BioLINCC, the Intermacs registry consisted of 170 active centers throughout the United States and Canada. Pedimacs consisted of 34 active sites.Any site with a MCSD program was eligible to participate in the Intermacs registry if they had a local Principal Investigator and a Site Administrator. In addition, each center paid a fee to Intermacs for activation. Once activated, the center entered data about each eligible patient who received an MCSD at the center, into the registry via the Intermacs website (www.intermacs.org). Patients are assigned an Intermacs registry identification number which is used as the primary identifier between the center, Intermacs, MCSD manufacturers, and government agencies. The type of data collected by Intermacs includes a patient's prior health history, demographic information, clinical visit measurements, adverse events, and device related information. The data primarily come from existing medical records or from standard of care, post implant clinical visits. Clinical visits are scheduled at 1 week, 1 month, 3 months, 6 months, and every 6 months post implantation. During the visits, patients are interviewed, receive a physical examination, and a functional capacity evaluation. The interview consists of a neurocognitive assessment and Quality of Life (QoL) questions from the EQ-5D-3L and Kansas City Cardiomyopathy Questionnaire (KCCQ) instruments. Pediatric patients are administered an age-appropriate functional capacity test and their interview consists of questions from the Pediatric Quality of Life Inventory (PedsQL) and Ventricular Assist Device Quality of Life (VADQoL) instruments. Centers continue to follow all patients who have an implanted MCSD. Patients who have the MCSD removed and are not transplanted continue to have their data collected for 1 year post explantation. If an individual has the MCSD device removed due to a transplant, Intermacs no longer collects data about the individual. Instead, the patient is followed by a transplant database such as the Organ Procurement and Transplant Network (OPTN). Lastly, if a patient transfers to another Intermacs center, the patient is deactivated from the implanting center and re-activated at a new center. Centers were incentivized to participate by receiving a quarterly quality assurance report and a post-implant chronological history for each patient. In addition, centers also received access to web-based data forms and could receive quality improvement datasets upon request.

Interagency Registry for Mechanically Assisted Circulatory Support    (Intermacs-BioLINCC)

Cardiovascular Diseases study on dbGaP (23,028 participants)

Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs-BioLINCC)

Description

Applying For Access

Summary