Clinical Impact of Standardized TAVR Technique and Care Pathway: Insights From the Optimize PRO Study. 

 -  2023 
<br/><br/>Available online through MWHC library: 2008 - present 
<br/><br/> BACKGROUND: Procedural success and clinical outcomes after transcatheter aortic valve replacement (TAVR) have improved, but residual aortic regurgitation (AR) and new permanent pacemaker implantation (PPI) rates remain variable because of a lack of uniform periprocedural management and implantation.  CONCLUSIONS: The use of the TAVR care pathway and COT resulted in favorable clinical outcomes with no moderate or severe AR and low PPI rates at 30 days while facilitating early discharge and reproducible outcomes across various sites and operators. (Optimize PRO; NCT04091048). Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.  METHODS: Optimize PRO, a nonrandomized, prospective, postmarket study conducted in the United States, Canada, Europe, Middle East, and Australia, is enrolling patients with severe symptomatic aortic stenosis and no pre-existing pacemaker. Sites follow a standardized TAVR care pathway, including early discharge and a conduction disturbance management algorithm, and transfemoral deployment using the COT.  OBJECTIVES: The Optimize PRO study evaluates valve performance and procedural outcomes using an "optimized" TAVR care pathway and the cusp overlap technique (COT) in patients receiving the Evolut PRO/PRO+ (Medtronic) self-expanding valves.  RESULTS: A total of 400 attempted implants from the United States and Canada comprised the main cohort of this second interim analysis. The mean age was 78.7 +/- 6.6 years, and the mean Society of Thoracic Surgeons predictive risk of mortality was 3.0 +/- 2.4. The median length of stay was 1 day. There were no instances of moderate or severe AR at discharge. At 30 days, all-cause mortality or stroke was 3.8%, all-cause mortality was 0.8%, disabling stroke was 0.7%, hospital readmission was 10.1%, and cardiovascular rehospitalization was 6.1%. The new PPI rate was 9.8%, 5.8% with 4-step COT compliance. In the multivariable model, right bundle branch block and the depth of the implant increased the risk of PPI, whereas using the 4-step COT lowered 30-day PPI. 
<br/><br/><br/>English 
<br/><br/><label>ISSN: </label>1936-8798 
<br/><br/><label>Standard No.: </label>10.1016/j.jcin.2023.01.016 [doi] S1936-8798(23)00017-1 [pii] 
<br/><br/><label>Subjects--Topical Terms: </label><br/>*Aortic Valve Insufficiency<br/>*Aortic Valve Stenosis<br/>*Heart Valve Prosthesis<br/>*Stroke<br/>*Transcatheter Aortic Valve Replacement<br/>Aged<br/>Aged, 80 and over<br/>Aortic Valve Insufficiency/et [Etiology]<br/>Aortic Valve Stenosis/co [Complications]<br/>Aortic Valve Stenosis/dg [Diagnostic Imaging]<br/>Aortic Valve Stenosis/su [Surgery]<br/>Aortic Valve/dg [Diagnostic Imaging]<br/>Aortic Valve/su [Surgery]<br/>Critical Pathways<br/>Heart Valve Prosthesis/ae [Adverse Effects]<br/>Humans<br/>Prospective Studies<br/>Risk Factors<br/>Transcatheter Aortic Valve Replacement/ae [Adverse Effects]<br/>Treatment Outcome<br/>United States
<br/><br/><label>Subjects--Geographic Terms: </label><br/>MedStar Union Memorial Hospital
<br/><br/><label>Index Terms--Occupation: </label><br/>Intrerventional Cardiology
<br/><br/><label>Index Terms--Function: </label><br/>Journal Article