Society of Thoracic Surgeons and American College of Cardiology Transcatheter Valve Therapy Registry (STS/ACC TVT Registry™): Registry Purpose and Research Objective

The STS/ACC TVT Registry™ (TVT Registry) was designed to support a national surveillance system to assess the prevalence, demographics, management, and outcomes of patients receiving transcutaneous valve therapies. The purposes of the TVT Registry include: (i) collecting pertinent and standardized data elements from participating hospitals, health care providers and others that measure and assess the quality of care for patients receiving TVT; (ii) providing confidential periodic reports to participating hospitals, health care providers and others, to evaluate and improve the quality of care in these areas; (iii) permitting and fostering appropriate research based upon the data collected by means of the TVT Registry; and (iv) to serve as a scalable data infrastructure for pre and post market studies.

The TVT Registry was created under the leadership of cardiovascular experts using available ACC-AHA and STS guidelines, data elements and definitions, previous trial data elements, Valve Academic Research Consortium (VARC) and other evidentiary sources and with critical input from participating sites regarding the feasibility of implementation and the burden of data collection. The process for developing the core registry dataset follows an established methodology for creating clinical data standards. In short, experts constitute a multi-disciplinary committee charged with initially outlining a set of key quality metrics to measure and describe the quality of care, using existing clinical practice guidelines as a blueprint. Through the measure/metric development process of specifying numerators and denominators, inclusion and exclusion criteria, a comprehensive set of data elements and definitions are created to capture the clinical characteristics, indications, procedural aspects and adverse outcomes of patients undergoing transcutaneous valve therapies. These data elements and definitions were then subjected to several phases of review and refinement, including public comment period, to gain consensus on the final data elements and definitions. Datasets are periodically revised to reflect current clinical practice and on-going scientific relevance.

Hospitals join the TVT Registry by agreeing to the terms of a specific contract that outlines the obligations of each party and the annual fees for participation. In addition, participating sites sign a Business Associate Agreement/Data Use Agreement with the American College of Cardiology Foundation (ACCF) and the The Society of Thoracic Surgeons (STS) as per the requirements of the Health Insurance Portability and Accountability Act of 1996 as amended (HIPAA). Patient-level data are submitted by participating hospitals to The Society of Thoracic Surgeons (STS) and American College of Cardiology Foundation's (ACCF) joint TVT Registry.

The data are collected retrospectively from existing medical records or concurrently in the normal course of treatment on patients who meet the inclusion criteria as outlined in the registry. Additional testing and contact with the patient outside the hospital episode of care is required for this registry at 30 days and optional at one year for follow up interview and physical examination. The physical examination is a routine portion of the care for these patients; the interview will consist of optional survey questions from the Kansas City Cardiomyopathy Questionnaire (KCCQ) as a Quality of Life (QOL) survey.

All registry data (in-hospital and follow-up) is captured by participating sites using an electronic data collection tool provided by the TVT Registry or using a certified software application that has been reviewed and certified as compliant with the transmission specifications established by the ACCF for the TVT Registry.

Protected Health Information (PHI), such as social security number, is collected. Registry sites can opt out of transmitting direct identifiers to the National Cardiovascular Data Registry (NCDR), so inclusion of direct identifiers in the registry is at the discretion of the registry site. When using the NCDR web-based data collection tool, direct identifiers are entered but a partition between the data collection process and the data warehouse maintains the direct identifiers separate from the analysis datasets. The minimum level of PHI transmitted to the ACCF when a participant opts out of submitting direct identifiers meets the definition of a Limited Dataset as such term is defined by HIPAA.

In recognition of the importance of data quality to all of its registry products, and to ensure that data submitted to the NCDR are complete, consistent, and accurate, a Data Quality Program was formally established by the NCDR in 2004. Upon receipt of the TVT Registry data submission, the ACCF reviews the data electronically and reports back coding errors. Such electronic checks verify consistency and completeness and allow participants to have ample opportunity to submit data until it satisfies consistency and completion thresholds. The report produced from these data checks is called a Data Quality Report (DQR).

The DQR provides the participant with a confidential analysis of their data submission's completeness and is used by the participant to help prioritize data cleaning efforts and to assess the necessity for re-submission. Once the data meets the data quality thresholds, it may be included in aggregation for the participant's data and national comparison.

The NCDR understands the need to ensure the data submitted to the TVT Registry is accurate and has a national audit program whereas a random set of participants are selected for an audit to confirm the data submitted to the registry is consistent with data in the medical record or source documentation.