The STS National Database has recently received funding from the FDA to assist in a detailed post-market surveillance of transmyocardial revascularization laser treatment (TMR) through development of a device registry. As in the Society's Adult Cardiac Database, the Duke Clinical Research Institute (DCRI) will provide the data warehouse and statistical analysis services for this grant. This registry is expected to provide valuable information on the use, safety and effectiveness of TMR.
TMR is becoming a more popular procedure in the U.S. as two laser systems have been introduced in the last 18 months. However, little data exists on the safety and effectiveness of TMR on women, as well as on other population segments. And while TMR is indicated for patients with severe angina who are not candidates for heart bypass surgery, the most appropriate clinical criteria for TMR treatment still are not established.
The FDA is looking to the STS Database to supplement its own post-market surveillance information. By using the STS database, FDA researchers can leverage more than 1.5 million patient procedures. Surgeons have been requested to submit a few extra data items relevant to TMR in addition to the more than 200 items already collected on each of their patients (TMR collection tool). The data will then be warehoused and analyzed at the DCRI, providing a global look at TMR use. Currently, fifty-three of the TMR sites participating in the Adult Cardiac Database have agreed to participate in the TMR device registry. The Society is hoping that all Adult Cardiac Database sites using TMR will participate.
The Society is pleased to support this effort because it feels that this type of information can improve patient care by defining the safety of the devices and helping to determine which patients are likely to benefit the most from this new technology. This is a unique partnership and possibly the first of its kind for the FDA. The Society hopes that this is the first of many potential relationships with the public sector and also with the private industry where resources that it and its members have developed can be used to improve patient outcomes.
If you have any questions, or would like to participate in the TMR device registry, please call or e-mail Meghan Carey at the STS Headquarters. (312/644-6610 ext. 3165 or meghan_carey@sba.com)