Global Results From the Optimize PRO Study: Standardized TAVR Technique and Care Pathway

Figures

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  Figure 1. Patient flowchart. The Optimize PRO study flowchart through the 30-day follow-up. Prior to transcatheter aortic valve replacement, 1 patient exited on the day of the procedure due to the inability to obtain vascular access and this was classified as an unsuccessful procedure. Overall, 652 patients received a transcatheter aortic valve replacement implant; 3 patients died and 649 were discharged. Following discharge, 3 patients withdrew, and 3 patients died. At the 30-day follow-up, data were expected for 643 patients, and 640 patients completed the 30-day follow-up.

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  Figure 2. Echocardiographic hemodynamics. (A) Aortic valve mean gradient (MG) (solid line) and effective orifice area (EOA) (dashed line) at baseline and discharge. Plot reports mean ± SD at each time point. (B) Prosthesis-patient mismatch (PPM) at discharge. PPM definition per Valve Academic Research Consortium-3.12

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  Figure 3. Aortic regurgitation at discharge. (A) Total aortic regurgitation and paravalvular regurgitation (PVR) at discharge. (B) PVR at discharge by valve size.

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  Figure 4. Thirty-day pacemaker implantation rate. (A) New 30-day permanent pacemaker implantation (PPI) Kaplan-Meier rate for patients based on compliance to 4-step cusp overlap technique (COT) and those with/or without preexisting right bundle branch block (RBBB) or baseline electrocardiogram RBBB. (B) New 30-day PPI Kaplan-Meier rate with or without Lunderquist wire breakdown by valve size. (C) New 30-day PPI Kaplan-Meier rate by noncoronary cusp (NCC) depth of implant, reported by the core laboratory.

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  Figure 5. Quality of life through 30 days. (A) Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score at baseline and 30 days and change from baseline, reported as mean ± SD. (B) KCCQ ordinal outcomes at 30 days using VARC-3 criteria: worsened = decrease from baseline >5 points; no change = change between –5 and <5 points; mildly improved = increase between 5 and <10 points; moderately improved = increase between 10 and <20 points; and substantially improved = increase ≥20 points. (C) New York Heart Association (NYHA) classification at baseline and 30 days. Patients who died prior to the 30-day visit are not included in the figure.

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  Central Illustration. Primary and secondary outcomes for the Optimize PRO global cohort. Outcomes were reported as Kaplan-Meier estimates at 30 days, median days from index procedure to discharge, or percentage of patients with ≥ moderate aortic regurgitation at discharge.