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Echo Assessment of Normal TAVR Function
Study Questions:
What are normal hemodynamics for currently available balloon-expandable and self-expanding transcatheter aortic valve replacement (TAVR) devices?
Methods:
Echocardiography core laboratory-derived mean pressure gradient and effective orifice area (EOA) were collected from discharge or 30-day post-TAVR echocardiograms in randomized clinical trials; data for balloon-expandable valves (Edwards Lifesciences; Irvine, CA) were derived from the PARTNER (Placement of Aortic Transcatheter Valves) trials, and data for self-expanding valves (Medtronic; St. Paul, MN) were derived from the Medtronic CoreValve US Pivotal trial and CoreValve Evolut R US IDE clinical study.
Results:
For all SAPIEN valve sizes, all SAPIEN XT valve sizes, and all SAPIEN 3 valve sizes, respective mean gradients were 9.4 ± 4.1 mm Hg, 9.5 ± 3.6 mm Hg, and 11.2 ± 4.4 mm Hg; and respective EOAs were 1.70 ± 0.49 cm2, EOA 1.67 ± 0.46 cm2, and 1.66 ± 0.38 cm2. For all three balloon-expandable devices, mean gradient decreased and EOA increased for larger compared to smaller valve sizes. For all CoreValve valve sizes and all Evolut R valve sizes, respective mean gradients were 8.9 ± 4.1 mm Hg and 7.5 ± 3.2 mm Hg; and respective EOAs were 1.88 ± 0.56 cm2 and 2.01 ± 0.65 cm2. For the two self-expanding devices, EOA progressively increased for larger compared to smaller valve sizes, and mean gradient was highest for the smallest valve size. For SAPIEN 3, the post-implantation EOA was progressively larger for each quintile of baseline computed tomography-derived aortic valve annular area (p < 0.001). Similarly, for the Evolut R valve, the post-implantation EOA was significantly larger for each quintile of baseline aortic valve annular perimeter (p < 0.001).
Conclusions:
This study provides expected data for mean gradient, EOA, and dimensionless valve index (DVI) by TAVR device type and size; and the authors propose definitions of structural valve dysfunction related to changes in hemodynamics, regurgitation, and/or valve morphology. The authors concluded that tables of normal TAVR hemodynamics are essential in evaluating the function of these devices, and that tables of expected EOA by native aortic valve annular anatomy may be useful for pre-implantation decision making.
Perspective:
This study provides echo core lab-derived data for pre-discharge or 30-day post-implantation echocardiographic hemodynamics (mean gradient, EOA, DVI) by valve size for balloon-expandable (SAPIEN, SAPIEN XT, SAPIEN 3) and self-expanding (CoreValve, Evolut R) TAVR devices. In addition, the authors propose criteria for possible subclinical structural valve dysfunction (gradient increase >10 mm Hg with decrease in EOA >25% and/or stroke volume index [SVI] >20%; new ≥ mild or increase ≥1 grade in aortic regurgitation [AR]; changes in morphology and/or leaflet mobility) and clinically relevant structural valve dysfunction (gradient increase >20 mm Hg with decrease in EOA >50% and/or SVI >40%; severe prosthetic aortic stenosis; new or increase ≥1 grade in AR resulting in ≥ moderate AR; severe changes in morphology and/or leaflet mobility).
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Imaging, Interventions and Structural Heart Disease, Computed Tomography, Echocardiography/Ultrasound, Nuclear Imaging
Keywords: Aortic Valve Insufficiency, Aortic Valve Stenosis, Cardiac Surgical Procedures, Diagnostic Imaging, Echocardiography, Heart Valve Diseases, Heart Valve Prosthesis, Hemodynamics, Stroke Volume, Tomography, Tomography, Emission-Computed, Transcatheter Aortic Valve Replacement
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