INTERMACS

INTERMACS
Name	INTERMACS
Formation	2005
Type	Medical registry
Headquarters	United States
Parent organization	National Heart, Lung, and Blood Institute; Society of Thoracic Surgeons

INTERMACS

INTERMACS is a United States-based registry and collaborative network that tracks outcomes for patients supported with durable mechanical circulatory support devices and related therapies. It serves as a centralized data resource used by clinicians, researchers, regulatory agencies, and manufacturers to evaluate device performance, patient characteristics, and survival, linking clinical centers, academic hospitals, professional societies, and federal agencies. The registry informs practice at institutions such as Cleveland Clinic, Mayo Clinic, Johns Hopkins Hospital, Massachusetts General Hospital, and supports guideline development by organizations like the American Heart Association and American College of Cardiology.

Overview

INTERMACS functions as a clinical registry coordinating contributions from tertiary centers including Mount Sinai Hospital (New York City), University of Michigan, Stanford Health Care, University of Pennsylvania Health System, and Duke University Hospital. Its dataset covers device implants such as devices by Thoratec Corporation, Abbott (company), Medtronic, Jarvik Heart, and investigational devices reviewed by the Food and Drug Administration and monitored by the National Institutes of Health. Stakeholders include professional groups like the Heart Failure Society of America and the International Society for Heart and Lung Transplantation as well as payers such as Centers for Medicare & Medicaid Services.

History and Development

INTERMACS began in the mid-2000s as a collaborative effort among academic centers, industry partners including Thoratec Corporation and Cleveland Clinic Innovations, and funding sources such as the National Heart, Lung, and Blood Institute. Early contributors included clinicians from Brigham and Women’s Hospital, University of Pittsburgh Medical Center, and Columbia University Irving Medical Center. The registry evolved alongside pivotal clinical trials at sites like University of Utah Health and regulatory milestones at the Food and Drug Administration, paralleling advances by manufacturers including Jarvik Heart and HeartMate (series). Governance and data standards were informed by entities such as the Society of Thoracic Surgeons and collaborations with the Agency for Healthcare Research and Quality.

Classification System

INTERMACS developed a patient severity classification used by transplant centers and device programs, influenced by contemporary practice at centers such as Cleveland Clinic and Mayo Clinic Hospital. The stratification categories align with clinical profiles seen at institutions like NewYork-Presbyterian Hospital and incorporate criteria referenced in guidelines from the American College of Cardiology and the European Society of Cardiology. The classification is applied in multicenter studies involving teams at University of California, Los Angeles, Vanderbilt University Medical Center, and Johns Hopkins Hospital to harmonize reporting across trials sponsored by industry partners such as Abbott (company) and overseen by regulators including the Food and Drug Administration.

Clinical Applications and Impact

Clinicians at referral centers including Cleveland Clinic Foundation, Massachusetts General Hospital Heart Center, and Mount Sinai Hospital (New York City) use INTERMACS profiles to guide timing for devices marketed by Medtronic, Abbott (company), and smaller firms. The registry informs allocation and candidacy decisions that intersect with transplantation programs at UCLA Medical Center, Emory University Hospital, and Stanford Health Care. Health systems and payers such as the Centers for Medicare & Medicaid Services reference INTERMACS-derived evidence when assessing coverage policies, while professional societies like the American Heart Association cite registry findings in consensus documents used by heart failure programs at Duke University Hospital and University of Pennsylvania Health System.

Data Collection and Registry Operations

INTERMACS aggregates data from member centers including University of Michigan Health System, Johns Hopkins Hospital, and Brigham and Women’s Hospital using standardized case-report forms and definitions adopted by the Society of Thoracic Surgeons. Data governance involves oversight from academic steering committees with investigators from Mayo Clinic and Cleveland Clinic. Collaborations with the National Institutes of Health and quality programs at Centers for Medicare & Medicaid Services support long-term follow-up, while industry partners such as Thoratec Corporation and Medtronic contribute device-specific variables used in postmarket surveillance reviewed by the Food and Drug Administration.

Research Findings and Outcomes

Analyses of INTERMACS data, conducted by investigators at University of Pittsburgh Medical Center, Vanderbilt University Medical Center, and Duke University Medical Center, have elucidated predictors of survival, complications, and rehospitalization after implantation of devices made by Abbott (company), Medtronic, and earlier platforms from Thoratec Corporation. Publications drawing on registry data have informed clinical practice at centers such as Massachusetts General Hospital and Cleveland Clinic and influenced guideline statements by the American College of Cardiology and the Heart Failure Society of America. Multicenter outcome studies using INTERMACS have been presented at meetings of the American Heart Association and the Society of Thoracic Surgeons and have guided device iterations by manufacturers including Jarvik Heart.

Criticisms and Limitations

Critiques from academic groups at Yale School of Medicine and Columbia University Medical Center have highlighted selection bias inherent in registry enrollment and variable completeness across centers like Community Health Network versus academic hospitals. Methodologists at institutions such as Harvard Medical School and Johns Hopkins Bloomberg School of Public Health note challenges in causal inference, device-era confounding, and under-representation of international sites beyond networks like European Society of Cardiology member centers. Regulators at the Food and Drug Administration and analysts at the Agency for Healthcare Research and Quality emphasize the need for linkage with claims databases from Centers for Medicare & Medicaid Services to improve outcome ascertainment.

Category:Medical registries