17 Dec Annual Report of Transcatheter Valve Therapy Registry
MedicalResearch.com Interview with:
Dr. Frederick Grover
Frederick L. Grover, M. D.
Professor, Division of Cardiothoracic Surgery
Past Chair, Department of Surgery
University of Colorado School of Medicine-Anschutz Medical Campus
Aurora, CO
Past President, Society of Thoracic Surgeons
Vice Chair, Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Following approval of the first transcatheter aortic heart valve late in 2011 the TVT-R was established and data entry was mandated by CMS for all patients who were undergoing transcatheter valve therapy. Data is currently collected on transcatheter aortic valves (TAVR) from two companies, transcatheter mitral clip procedures (TMC), transcatheter mitral valve in valve or valve in ring procedures and aortic valve in valve procedures. A report is published annually jointly in the Journal of the American College of Cardiology (JACC) and the Annals of Thoracic Surgery (ATS). This report contains data from the beginning of 2012 through December 31, 2015. Peoperative risk factors, operative details and outcomes data are collected prior to procedures, during the hospitalization, 30 days post procedure and at one year and later data can be collected by linking to CMS administrative data.
For this annual report we concentrated on touching on some of the highlights since the length of the manuscript is limited. We discussed the trends in TAVR, since this is the most common procedure performed, the last two years’ experience in mitral clips since a very detailed paper was published on this last year, and the mitral valve in valve and ring since the results for this procedure were impressively good.
In regard to TAVR, 418 sites perform this procedure and the number of cases in 2015 increased from 16,295 in 2014 to 24,808. Very importantly, mortality and complications have been decreasing each year, probably related to improvements in the technology with smaller catheter and sheath sizes leading to less vascular complications, greater experience of those doing the procedures, a less sick group of patients going initially from those too ill to do an open operation on, to very high risk to high risk according to approval criteria. The age of the patients however is most often in the 80s.
In 2015 2,556 transcatheter mitral clip procedures were performed as compared to 1,141 in 2014. These are performed only on those patients with mitral regurgitation who are thought to be too sick to undergo an open operation. The mortality and complication rates from the procedure are relatively low and the procedure reduces the mitral regurgitation in the majority of patients.
The transcatheter mitral valve in valve and valve in ring procedure was performed in patients who were very high risk fo an open operation. This procedure is performed in those who have had a previous mitral valve replacement with a tissue (bioprosthetic) valve via a conventional open operation generally performed years earlier which has degenerated over time resulting in regurgitation or stenosis producing some narrowing of its opening. Patients having the transcatheter procedure were able to receive the valve because of compassionate use because of their very high risk with an open procedure. In 2015 248 procedures were performed as compared to 96 in 2014. The mortality rate 30 days following the procedure was 25% to 30% less than the predicted mortality with an open procedure in this high risk group. Also, the new valves functioned quite well. It is hoped that these findings will stimulate some in depth studies of our data to see if the valve can be utilized more for this purpose.
MedicalResearch.com: What should readers take away from your report?
Response: In general, over the time period from 2012 through 2015 the results of these procedures in generally a high risk older population have steadily improved with more procedure success, less deaths and complications and therefore increased utilization of this new technology. The manufacturers continue to make improvements in the devices which has contributed to the better results. For these reasons the volume of procedures performed has continuously increased over time. An area that is not known as yet, however, is how the long term durability of these valves and procedures will compare to the conventional open procedures and the tissue valves implanted in the open technique, many of which last of 16 years or so. In lower risk and younger patients the durability will be a more significant factor. At this point durability of the transcatheter valves has not been an issue but our data only goes out to 5 to 6 years.
MedicalResearch.com: Is there anything else you would like to add?
Response: The procedures are performed by a team of cardiologists and cardiothoracic surgeons working very closely together, evaluating the patients preoperatively, participating in the procedure together and in the care afterwards. The TVT-R has brought together physicians, FDA, CMS, NIH, industry, patients, and other stakeholders. It is the hope of the FDA and all of us that the added “real world” post market surveillance of the devices and monitoring of quality and performance of the increasing number of hospitals performing these procedures will allow FDA to approve these and other potentially life saving devices sooner in the future knowing that the device performance will be closely monitored after implantation.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Citation:
Frederick L. Grover, Sreekanth Vemulapalli, John D. Carroll, Fred H. Edwards, Michael J. Mack, Vinod H. Thourani, Ralph G. Brindis, David M. Shahian, Carlos E. Ruiz, Jeffrey P. Jacobs, George Hanzel, Joseph E. Bavaria, E. Murat Tuzcu, Eric D. Peterson, Susan Fitzgerald, Matina Kourtis, Joan Michaels, Barbara Christensen, William F. Seward, Kathleen Hewitt, David R. Holmes, STS/ACC TVT Registry
Journal of the American College of Cardiology
December 2016 DOI: 10.1016/j.jacc.2016.11.033
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Last Updated on December 17, 2016 by Marie Benz MD FAAD