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Published on: February 26, 2013
30-Day and 1-Year Outcomes From the Optimize PRO TAVR Evolut FX Addendum Study
Hemal Gada1, Ramzi F Khalil2, Stanley J Chetcuti3
1University of Pittsburgh Medical Center Central Pennsylvania Hospitals, Harrisburg, Pennsylvania, USA.
Insights
Transcatheter aortic valve replacement (TAVR) with the Evolut FX device using the cusp overlap technique (COT) showed low permanent pacemaker implantation (PPI) rates and no severe aortic regurgitation (AR) at one year. Post-procedure computed tomography (CT) confirmed good valve alignment.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Devices
Background:
- The Optimize PRO study previously showed transcatheter aortic valve replacement (TAVR) using the cusp overlap technique (COT) yielded low rates of permanent pacemaker implantation (PPI) and no moderate or severe aortic regurgitation (AR).
- This follow-up study aimed to further assess outcomes with the Evolut FX device and COT.
Purpose of the Study:
- To evaluate the clinical outcomes of Evolut FX device implantation using the COT in patients with severe aortic stenosis.
- To assess the accuracy of postprocedural computed tomography (CT) in evaluating transcatheter aortic valve orientation and alignment.
Main Methods:
- A prospective, multicenter, nonrandomized study involving 151 patients undergoing TAVR with the Evolut FX device and COT.
- Evaluation of COT adherence, comparison of CT-assessed valve orientation with fluoroscopic guidance, and assessment of commissural and coronary alignment.
Main Results:
- The refined COT adherence was 86.0%, with a median length of stay of 1 day.
- At 1 year, the rate of all-cause mortality or stroke was 7.5%, and the PPI rate was 8.8%.
- No severe AR was observed at 1 year. CT and fluoroscopy showed good agreement for commissural alignment (86.9% vs 91.5%), with CT indicating no severe coronary misalignment in over 92% of patients.
Conclusions:
- Implantation of the Evolut FX device using a refined COT is associated with favorable clinical outcomes, including low PPI rates and no severe AR at one year.
- Postprocedural CT is a reliable tool for assessing valve alignment, confirming consistent commissural and coronary positioning.
Background:
Primary results from the Optimize PRO study demonstrated that transcatheter aortic valve replacement (TAVR) with the cusp overlap technique (COT) resulted in low 30-day permanent pacemaker implantation (PPI) rates and no moderate or greater aortic regurgitation (AR).
Objectives:
The aim of this study was to evaluate outcomes after Evolut FX implantation using the COT and postprocedural computed tomography (CT).
Methods:
The Optimize PRO FX Addendum study is a postmarket, prospective, multicenter, nonrandomized study. Patients with severe aortic stenosis underwent TAVR with the Evolut FX using the COT protocol. Postprocedurally, COT adherence was evaluated to identify key steps, and CT-assessed transcatheter aortic valve orientation was compared with fluoroscopically guided commissural alignment.
Results:
A total of 151 patients received the Evolut FX device from September 2022 to October 2023. The median duration of follow-up was 371 days (Q1-Q3: 352-388 days). Compliance with the refined COT was 86.0%. The median length of stay was 1 day. The rate of the primary endpoint of all-cause mortality or all stroke was 2.7% (95% CI: 1.0%-6.9%) at 30 days and 7.5% (95% CI: 4.2%-13.1%) at 1 year. The new PPI rate was 6.7% (95% CI: 3.7%-12.1%) at 30 days and 8.8% (95% CI: 5.2%-14.6%) at 1 year. One patient had moderate AR and none had severe AR at 1 year. The rate of commissural alignment was 91.5% (107 of 117) when assessed by marker positioning on fluoroscopy and 86.9% (113 of 130) when assessed using CT, indicating good agreement. CT indicated no severe coronary misalignment in >92% of patients.
Conclusions:
Implantation of the Evolut FX device with a refined COT was associated with low PPI rates and no severe AR at 1 year. Postprocedural CT demonstrated consistent commissural and coronary alignment.
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