Author + information
- Received October 17, 2016
- Revision received November 20, 2016
- Accepted November 28, 2016
- Published online March 6, 2017.
- Frederick L. Grover, MDa,b,∗ (, )
- Sreekanth Vemulapalli, MDc,
- John D. Carroll, MDd,
- Fred H. Edwards, MDe,
- Michael J. Mack, MDf,
- Vinod H. Thourani, MDg,
- Ralph G. Brindis, MD, MPHh,
- David M. Shahian, MDi,
- Carlos E. Ruiz, MDj,
- Jeffrey P. Jacobs, MDk,l,
- George Hanzel, MDm,
- Joseph E. Bavaria, MDn,
- E. Murat Tuzcu, MDo,
- Eric D. Peterson, MD, MPHc,
- Susan Fitzgerald, RN, MSp,
- Matina Kourtis, MSq,
- Joan Michaels, RN, MSNp,
- Barbara Christensen, MSHA, RNp,
- William F. Seward, MAq,
- Kathleen Hewitt, MSN, RNp,
- David R. Holmes Jr., MDr,
- STS/ACC TVT Registry
- aDepartment of Surgery, School of Medicine, University of Colorado, Anschutz Medical Campus, Aurora, Colorado
- bDenver Department of Veterans Affairs Medical Center, Denver, Colorado
- cDuke University Medical Center, Durham, North Carolina
- dSchool of Medicine, University of Colorado, Anschutz Medical Campus, Aurora, Colorado
- eUniversity of Florida, Jacksonville, Florida
- fBaylor Scott and White Health, Plano, Texas
- gEmory University, Atlanta, Georgia
- hUniversity of California, San Francisco, California
- iMassachusetts General Hospital, Boston, Massachusetts
- jStructural and Congenital Heart Center, Hackensack University Medical Center and The Joseph M. Sanzari Children’s Hospital, Seton Hall Hackensack University–School of Medicine, Hackensack, New Jersey
- kDivision of Cardiac Surgery, Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland
- lDivision of Cardiovascular Surgery, Department of Surgery, Johns Hopkins All Children’s Heart Institute, All Children’s Hospital and Florida Hospital for Children, St. Petersburg, Tampa, and Orlando, Florida
- mBeaumont Hospital, Royal Oak, Michigan
- nDivision of Cardiovascular Surgery, University of Pennsylvania, Philadelphia, Pennsylvania
- oCleveland Clinic, Abu Dhabi, United Arab Emirates
- pAmerican College of Cardiology, Washington, DC
- qThe Society of Thoracic Surgeons, Chicago, Illinois
- rMayo Clinic, Rochester, Minnesota
- ↵∗Address for correspondence:
Dr. Frederick L. Grover, University of Colorado School of Medicine, Anschutz Medical Campus, Department of Surgery, Academic Office 1, Room 6613, 12631 E. 17th Avenue, MSC310, Aurora, Colorado 80045.
Background The Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry captures all procedures with Food and Drug Administration–approved transcatheter valve devices performed in the United States, and is mandated as a condition of reimbursement by the Centers for Medicaid & Medicare Services.
Objectives This annual report focuses on patient characteristics, trends, and outcomes of transcatheter aortic and mitral valve catheter-based valve procedures in the United States.
Methods We reviewed data for all patients receiving commercially approved devices from 2012 through December 31, 2015, that are entered in the TVT Registry.
Results The 54,782 patients with transcatheter aortic valve replacement demonstrated decreases in expected risk of 30-day operative mortality (STS Predicted Risk of Mortality [PROM]) of 7% to 6% and transcatheter aortic valve replacement PROM (TVT PROM) of 4% to 3% (both p < 0.0001) from 2012 to 2015. Observed in-hospital mortality decreased from 5.7% to 2.9%, and 1-year mortality decreased from 25.8% to 21.6%. However, 30-day post-procedure pacemaker insertion increased from 8.8% in 2013 to 12.0% in 2015. The 2,556 patients who underwent transcatheter mitral leaflet clip in 2015 were similar to patients from 2013 to 2014, with hospital mortality of 2% and with mitral regurgitation reduced to grade ≤2 in 87% of patients (p < 0.0001). The 349 patients who underwent mitral valve-in-valve and mitral valve-in-ring procedures were high risk, with an STS PROM for mitral valve replacement of 11%. The observed hospital mortality was 7.2%, and 30-day post-procedure mortality was 8.5%.
Conclusions The TVT Registry is an innovative registry that that monitors quality, patient safety and trends for these rapidly evolving new technologies.
- procedural outcomes
- procedural risk
- transcatheter mitral clip
- transcatheter valves
- valve in valve
Dr. Grover is the recipient of a Thoracic Surgery Foundation grant for medical mission work in Nepal, funded by Edwards. Dr. Vemulapalli has received research grants from Abbott Vascular, the American College of Cardiology, and The Society of Thoracic Surgeons; and has served as a consultant for Novella and Premiere Research. Dr. Mack has served as the co-principal investigator for the Partner 3 trial and COAPT trial. Dr. Thourani has served as a consultant for Edwards. Dr. Ruiz has received institutional educational grants from Medtronic; and institutional grants from Philips. Dr. Hanzel has served as an unpaid proctor for the Watchman device from Boston Scientific. Dr. Bavaria is a primary investigator for Edwards Lifesciences and Medtronic; and a sub primary investigator for St. Jude Medical and Boston Scientific. Dr. Peterson has served as the co-principal investigator of the Data Coordinating Center for The Society of Thoracic Surgeons-American College of Cardiology Transcatheter Aortic Valve Replacement. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
This article is copublished in the Journal of the American College of Cardiology and The Annals of Thoracic Surgery.
- Received October 17, 2016.
- Revision received November 20, 2016.
- Accepted November 28, 2016.
- American College of Cardiology Foundation and The Society of Thoracic Surgeons