1. Clinical Impact of Standardized TAVR Technique and Care Pathway: Insights From the Optimize PRO Study.
- Author
-
Grubb KJ, Gada H, Mittal S, Nazif T, Rodés-Cabau J, Fraser DGW, Lin L, Rovin JD, Khalil R, Sultan I, Gardner B, Lorenz D, Chetcuti SJ, Patel NC, Harvey JE, Mahoney P, Schwartz B, Jafar Z, Wang J, Potluri S, Vora AN, Sanchez C, Corrigan A, Li S, and Yakubov SJ
- Subjects
- Humans, United States, Aged, Aged, 80 and over, Aortic Valve diagnostic imaging, Aortic Valve surgery, Critical Pathways, Prospective Studies, Risk Factors, Treatment Outcome, Transcatheter Aortic Valve Replacement adverse effects, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis surgery, Aortic Valve Stenosis complications, Aortic Valve Insufficiency etiology, Stroke, Heart Valve Prosthesis adverse effects
- Abstract
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., 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., 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., 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., 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)., Competing Interests: Funding Support and Author Disclosures This study was funded by Medtronic. Dr Grubb is a proctor, principal investigator, and on the advisory board for Medtronic; and serves on the advisory board or is a consultant for Ancora Heart, Boston Scientific, Abbott, Gore, BioVentrix, and Edwards Lifesciences. Dr Gada has served as a consultant to Abbott, Bard Medical Corporation, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Mittal has received honoraria/consultant fees from Abbott, Boston Scientific, and Medtronic. Dr Nazif is consultant for and has received institutional grants from Edwards LifeSciences, Medtronic, and Boston Scientific. Dr Rodes-Cabau has received institutional research grants from Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Fraser is a proctor for Medtronic; and receives speaker fees from Edwards and Medtronic. Dr Rovin is a physician proctor with Medtronic and Abbott; and is a consultant for Medtronic and Abbott. Dr Sultan receives institutional research support from Abbott, Atrivion, Boston Scientific, Edwards Lifesciences, and Medtronic; and is a consultant for Medtronic Vascular. Dr Gardner has received research support from Abbott; and is on the advisory board, is a consultant, and has received research support from Medtronic. Dr Chetcuti has received grant support and fees for proctoring from Medtronic; and is a consultant for Jena valve. Dr Patel is a speaker for Medtronic and Penumbra; and is on the advisory board of St. Jude Medical. Dr Harvey has served as a consultant; and is on the advisory board for Boston Scientific. Dr Mahoney is a proctor and consultant for Medtronic, Edwards Lifesciences, and Boston Scientific. Dr Schwartz is an investigator for Medtronic. Dr Jafar is an investigator for Medtronic. Dr Wang is a speaker and consultant for Boston Scientific; is a consultant for Cordis; and is a consultant for Edwards Lifesciences. Dr Potluri has received honoraria from Boston Scientific, Medtronic, Edwards Lifesciences, Zoll, Gore, Abbott, and Cardinal. Dr Vora serves as a consultant for Medtronic. Dr Sanchez is a consultant for Edwards Lifesciences and Medtronic. Ms Corrigan is an employee and shareholder of Medtronic. Dr Li is an employee and shareholder of Medtronic. Dr Yakubov has received institutional research grants from Medtronic; and serves on an advisory board for Medtronic and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)
- Published
- 2023
- Full Text
- View/download PDF