Monitoring and improving the quality of health care delivered to patients must be a top priority for physicians and hospitals. However, there are many arguments as to how this should be done.
Almost twenty years ago, the American College of Cardiology (ACC) created the National Cardiovascular Data Registry (NCDR) to improve “cardiovascular care through the use and application of clinical data.”1 Specifically, the ACC has created ten registries to capture and report procedure-specific data. Currently, the only NCDR registry that is related to heart rhythm disorders is the ICD Registry, which was created on October 27, 2005. Although one must be careful to be too negative about initiatives with good intentions, legitimate arguments can be made about the value of the ICD Registry relative to the work needed to participate. In spite of nearly 70 publications based on the ICD Registry, it is difficult to see any significant impact that it has had on the quality of device therapy. For example, data from the registry has demonstrated that there is a higher complication rate when an ICD is implanted by a cardiac surgeon rather than an electrophysiologist. However, what impact has this data had on the volume of devices placed by surgeons, or on hospital credentialing decisions? It is critical to monitor local procedural outcomes related to ICD therapy, and the registry allows physicians and hospitals to do that; however, the burden associated with completion of the entire data collection sheet for the ICD Registry after each case is excessive. It is likely that hospitals are only participating in the ICD Registry because it is considered mandatory for payment by Medicare. Alternative, less onerous registries are needed to allow hospitals to more efficiently track major complication rates by physician and institution.
In addition to the questionable impact that registries have had on quality, there are several other problematic issues that the registries create. According to the NCDR, more than 2,400 hospitals and over 2,000 outpatient providers worldwide now participate in one or more of the ACC’s ten registries.2 Individual hospitals are spending over one million dollars per year on nurses to abstract the data for the registries, data entry personnel, other administrators, and annual fees to participate in cardiovascular registries. This certainly has a negative impact on the cost of health care. Is the public getting what it is paying for?
Another issue raised by the NCDR registries is that of patient consent. Is it okay that data is collected on every patient undergoing ICD implantation and being published in the literature without patient consent, or at least approval by a local IRB with a waiver of consent? Although many hospitals do pursue IRB approval for anonymous registries like these, it is not clear that the NCDR confirms that each institution has obtained local IRB approval before publishing the data. This would not be permitted if it were a physician-initiated study. Should the fact that the data is required by the government for reimbursement and is anonymous a legitimate argument for doing research without IRB approval?
The ACC states that their NCDR AFib Ablation Registry™ is “coming soon.” Again, improving the quality of care delivered by heart rhythm specialists is a laudable goal. One could imagine that collection of the rates of the well-known major complications related to AF ablation would suffice. Instead, however, the ACC is proposing completion of a lengthy data collection sheet for the AFib Ablation Registry™ that has over 250 data points. The numbers of data points for each category in the form are listed in the table below.
The nine-page form and its accompanying 87-page Coder’s Data Dictionary are daunting. This registry will impose an incredible burden on physicians and hospitals. In addition, this registry introduces an unusual requirement: a 20-question patient quality of life questionnaire. Requiring patients to complete a QOL form is not currently considered standard of care, and participation in a registry does not establish the local standard of care. So how could these data be collected from patients without consent?
Efforts to improve the quality of care of patients with heart rhythm disorders must continue, and registries play a part in those efforts. It is anticipated that Medicare will establish that participation in the ACC NCDR® Left Atrial Appendage Occlusion (LAAO) Registry™ will be a requirement for reimbursement in connection with a National Coverage Determination for Boston Scientific’s WATCHMAN LAA closure device. However, registry creep that results in a requirement to collect over 250 data points for each procedure and the creation of new registries for already established procedures, such as ablation for atrial fibrillation, creates an unfunded mandate, adds to the cost of health care for patients, and does not necessarily improve outcomes. Simpler, more focused procedural outcome registries that achieve the same goals are needed.
- About NCDR. American College of Cardiology. Available online at http://cvquality.acc.org/NCDR-Home/About-NCDR.aspx. Accessed January 20, 2016.
- Registries. American College of Cardiology. Available online at http://cvquality.acc.org/NCDR-Home/Registries.aspx. Accessed January 20, 2016.