Annual Outcomes With Transcatheter Valve Therapy

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Presentation transcript:

Annual Outcomes With Transcatheter Valve Therapy David R. Holmes, MD, Rick A. Nishimura, MD, Frederick L. Grover, MD, Ralph G. Brindis, MD, MPH, John D. Carroll, MD, Fred H. Edwards, MD, Eric D. Peterson, MD, MPH, John S. Rumsfeld, MD, PhD, David M. Shahian, MD, Vinod H. Thourani, MD, E. Murat Tuzcu, MD, Sreekanth Vemulapalli, MD, Kathleen Hewitt, RN, MSN, Joan Michaels, RN, MSNm, Susan Fitzgerald, RN, MS, Michael J. Mack, MD The Annals of Thoracic Surgery Volume 101, Issue 2, Pages 789-800 (February 2016) DOI: 10.1016/j.athoracsur.2015.10.049 Copyright © 2016 The Society of Thoracic Surgeons and the American College of Cardiology Foundation Terms and Conditions

Central Illustration Cumulative TAVR Procedures and Valve Sheath Access Sites of Patients Submitted to the TVT Registry, 2012 to 2014. (A) Since the Food and Drug Administration (FDA) approval of transcatheter aortic valve replacement (TAVR) in 2011, there has been marked increase in procedural volume, the result of enhanced recognition of the problem of severe aortic stenosis in elderly higher-risk patients and technological improvements making the devices and procedure safer. (B) The changing valve sheath access site strategy is the result of multiple factors, including the FDA instructions for use, the presence or absence of peripheral arterial disease, and changing technology. (TVT = transcatheter valve therapy.) The Annals of Thoracic Surgery 2016 101, 789-800DOI: (10.1016/j.athoracsur.2015.10.049) Copyright © 2016 The Society of Thoracic Surgeons and the American College of Cardiology Foundation Terms and Conditions

Fig 1 Sites Enrolled in the TVT Registry, 2012 to 2014. As part of regulatory approval, the Centers for Medicare & Medicaid Services published a National Coverage Determination that described optimal characteristics of sites to be involved in transcatheter aortic valve replacement (TAVR), as well as required enrollment of all consecutive TAVR patients as a requirement for reimbursement. This resulted in the rapid growth of U.S. centers (Central Illustration). (TVT = transcatheter valve therapy.) The Annals of Thoracic Surgery 2016 101, 789-800DOI: (10.1016/j.athoracsur.2015.10.049) Copyright © 2016 The Society of Thoracic Surgeons and the American College of Cardiology Foundation Terms and Conditions

Fig 2 Age of Patients Undergoing TAVR, 2012 to 2014. The majority of patients from 2012 to 2013 and 2014 are from 80 to 90 years of age. Although there were significant differences over time, these differences were not clinically significant. (TAVR = transcatheter aortic valve replacement.) The Annals of Thoracic Surgery 2016 101, 789-800DOI: (10.1016/j.athoracsur.2015.10.049) Copyright © 2016 The Society of Thoracic Surgeons and the American College of Cardiology Foundation Terms and Conditions

Fig 3 pre-TAVR Health Status (KCCQ)—Overall Summary Score at Baseline. Kansas City Cardiomyopathy Questionnaire (KCCQ) data were only obtained in approximately 76% of patients. Given the size of the sample, the results indicated that the patients have poor health status. (TAVR = transcatheter aortic valve replacement.) The Annals of Thoracic Surgery 2016 101, 789-800DOI: (10.1016/j.athoracsur.2015.10.049) Copyright © 2016 The Society of Thoracic Surgeons and the American College of Cardiology Foundation Terms and Conditions

Fig 4 STS Risk Score (SAVR) of Patients Undergoing TAVR. (A) Percentiles. (B) Distribution of Society of Thoracic Surgeons (STS) risk scores for surgical aortic valve replacement (SAVR) (%) of patients undergoing transcatheter aortic valve replacement (TAVR). Two surgeons calculate the STS Predicted Risk of Mortality (PROM) score as part of the TAVR screening process. The expansion of the TAVR instructions for use to include lower-risk patients has resulted in a decline in STS scores. The Annals of Thoracic Surgery 2016 101, 789-800DOI: (10.1016/j.athoracsur.2015.10.049) Copyright © 2016 The Society of Thoracic Surgeons and the American College of Cardiology Foundation Terms and Conditions

Fig 5 Heart Team Reason for TAVR. The heart team is mandated to evaluate all patients undergoing transcatheter aortic valve replacement (TAVR). The reason for the indication for TAVR, in terms of patient risk, continues to evolve. The Annals of Thoracic Surgery 2016 101, 789-800DOI: (10.1016/j.athoracsur.2015.10.049) Copyright © 2016 The Society of Thoracic Surgeons and the American College of Cardiology Foundation Terms and Conditions

Fig 6 Aortic Regurgitation at Discharge (%) Post-TAVR. The small, but significant, changes in site-read aortic regurgitation post-transcatheter aortic valve replacement (TAVR) may have important implications. (Echo = echocardiography.) The Annals of Thoracic Surgery 2016 101, 789-800DOI: (10.1016/j.athoracsur.2015.10.049) Copyright © 2016 The Society of Thoracic Surgeons and the American College of Cardiology Foundation Terms and Conditions

Fig 7 Cardiac Complications of Patients Undergoing TAVR. The need for and placement of a new pacemaker or implantable cardioverter-defibrillator (ICD) has probably increased, in part, because of the introduction of new transcatheter aortic valve replacement (TAVR) devices. (Afib = atrial fibrillation.) The Annals of Thoracic Surgery 2016 101, 789-800DOI: (10.1016/j.athoracsur.2015.10.049) Copyright © 2016 The Society of Thoracic Surgeons and the American College of Cardiology Foundation Terms and Conditions

Fig 8 Neurological Complications of Patients Undergoing TAVR. Although infrequent, neurological complications following transcatheter aortic valve replacement (TAVR) identify patients at increased risk of subsequent mortality. (TIA = transient ischemic attack.) The Annals of Thoracic Surgery 2016 101, 789-800DOI: (10.1016/j.athoracsur.2015.10.049) Copyright © 2016 The Society of Thoracic Surgeons and the American College of Cardiology Foundation Terms and Conditions

Fig 9 Bleeding and Vascular Complications of Patients Undergoing TAVR. Newer technology, with smaller devices and improved vascular access management techniques, has led to a decreasing incidence of both vascular and bleeding complications. (TAVR = transcatheter aortic valve replacement.) The Annals of Thoracic Surgery 2016 101, 789-800DOI: (10.1016/j.athoracsur.2015.10.049) Copyright © 2016 The Society of Thoracic Surgeons and the American College of Cardiology Foundation Terms and Conditions

Fig 10 In-Hospital Mortality of Patients Undergoing TAVR. Unadjusted in-hospital mortality in patients undergoing transcatheter aortic valve replacement (TAVR) is decreasing; with improved technology, operator experience, and case selection, this trend can be expected to continue. The Annals of Thoracic Surgery 2016 101, 789-800DOI: (10.1016/j.athoracsur.2015.10.049) Copyright © 2016 The Society of Thoracic Surgeons and the American College of Cardiology Foundation Terms and Conditions