This month's guest blog post comes to us from ACC Vice President Ralph Brindis, M.D., F.A.C.C. Dr. Brindis is the Senior Advisor for Cardiovascular Disease for Northern California Kaiser and a Clinical Professor of Medicine at the University of California-San Francisco, and has been a leader within the College's NCDR for years. 

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The College has positioned itself as a true leader in the assessment and promotion of cardiovascular quality through the development of data standards, clinical practice guidelines, performance measures and appropriateness use criteria. Data collection via the NCDR registry portfolio is another key asset that is continuing to evolve since the first registry, CathPCI, was launched in 1998.

To date, the NCDR has become an important advocacy vehicle for our ACC membership in meeting mandates from national and state governments, payers and consumer demands for quality assessment. There have also been well over 100 NCDR publications advancing the field of CV outcome research, answering questions that clinical trials cannot – particularly on select subgroups of patients typically not included in clinical trials. 

Moving forward, the FDA is increasingly turning to NCDR because of its huge potential to be a vehicle for post-market device/drug surveillance. To date, our main challenges for post-market device/drug surveillance – or for that matter, for assessing long-term clinical outcomes – is harnessing viable financial models and developing the scientific ability to accomplish true longitudinal follow-up of our patients.    

Another exciting potential role for the NCDR is in aiding the diffusion of new cardiovascular technology into health care practices. Our present approval system for small clinical trials for new devices misses opportunities for evaluations of broad-based community use of these devices in older patient subgroups and for off-label indications. Meanwhile, imaging technologies typically are released into the marketplace with very few or no clinical trials assessing their impact on clinical outcomes or even intermediate outcomes and clinical decision-making. Coverage and payment decisions for these newer procedures and technologies is complex and typically quite variable because of local CMS coverage decisions, variable private payer coverage decisions and even national CMS coverage decisions.

- By Ralph Brindis, M.D., F.A.C.C., ACC Vice President

* Dr. Brindis' post is the second in a new monthly series of guest posts by ACC leadership. Check back next month to see which ACC leader is sharing his or her thoughts on health care reform!

 

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