Transcatheter Aortic Valve Replacement Program in the Post-Food and Drug Administration Approval Era: Early Outcomes at an Academic Medical Center

Abstract

<jats:sec><jats:title>Objective</jats:title><jats:p> Transcatheter aortic valve replacement (TAVR) has recently become a suitable alternative for treatment of symptomatic aortic stenosis in patients who are at very high risk for morbidity and mortality with conventional corrective surgery. In the fall of 2011, the Food and Drug Administration approved the use of TAVR, allowing for reimbursement at institutions outside of investigative trials. We report the initiation of a TAVR-based program at an academic tertiary care facility that did not participate in the Placement of Aortic Transcatheter Valves (PARTNER) 1 or PARTNER II trials. </jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p> A total of 160 patients were evaluated for TAVR from May 2012 through June 2013. Transcatheter aortic valve replacement was found to be appropriate for 50 (31%). </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> In this experience, morbidity and mortality were similar to those reported for the PARTNER trial (30-day hospital mortality was 8%). A single case of presumed cerebrovascular accident was observed. These results demonstrate that the real-world application can be done with comparable results. Implementation of lessons learned in the trials allowed a very short learning curve and excellent results after only a limited number of patients. Use of computed tomography reconstructed images for operative planning, including fluoroscopic angle, facilitated minimal use of contrast in each case. </jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p> Transcatheter aortic valve replacement is a viable option for patients at very high risk for surgical intervention in the post-Food and Drug Administration approval era. Real-world results comparable with published outcomes from experienced centers involved in the PARTNER trial can be achieved. </jats:p></jats:sec>

The Association of Economic Outcome and Geriatric Syndromes among Older Adults with Transcatheter Aortic Valve Replacement (TAVR)

“…Since the US Food and Drug Administration approved TAVR in 2011, indications for TAVR have expanded, and it is now considered to be standard for frail older adults with severe aortic stenosis. 1 , 2 Patients who are undergoing TAVR tend to be older and frail, and are subsequently at higher risk of developing delirium. 3 – 5 Delirium after a cardiac procedure such as TAVR is associated with adverse clinical and economic outcomes, including higher perioperative mortality, longer hospital stay, and higher total hospital cost.…”

The utility of live video capture to enhance debriefing following transcatheter aortic valve replacement

“…This expansion has brought new physical, technical, and environmental demands to the hospital teams asked to support these new endeavors. Transcatheter aortic valve replacement (TAVR) is an example of a relatively new procedure (Food and Drug Administration approval in the United States in 2011)[12] performed in a procedural setting with multiple medical teams working together. In our institution, this procedure is done in our Heart Catheterization Laboratory with teams from interventional cardiology, cardiovascular surgery, echocardiography, and cardiovascular anesthesia sharing a space typically reserved for the cardiology team alone.…”

“…TAVR is indicated for inoperable or high-risk patients for surgical aortic valve replacement and has demonstrated success in intermediate-risk patients as well (partner 2 trial). [2] The nature of these high-risk patients increases the technical and organizational demands and challenges of institutions to provide high-quality care with an increasing focus on patient safety.…”