Considerations for Optimal Device Selection in TAVR

Claessen BE, Tang GH, Kini AS, Sharma SK.
Considerations for Optimal Device Selection in Transcatheter Aortic Valve Replacement: A Review. JAMA Cardiol 2020;Sep 9:[Epub ahead of print].

The following are key points to remember from this review on considerations for optimal device selection in transcatheter aortic valve replacement (TAVR):

  1. There are several devices from which to choose when performing TAVR for aortic stenosis (AS). Food and Drug Administration (FDA)-approved current-generation devices include SAPIEN 3, SAPIEN 3 Ultra, Evolut PRO+, and LOTUS Edge. Devices currently under clinical investigation include ACURATE neo2 and Portico, also the JenaValve and J-valve, which can be used in aortic insufficiency. The devices have different characteristics with regard to expansion (balloon vs. self vs. mechanically expandable), intra- vs. supra-annular leaflet position, repositionability, frame material, leaflet tissue, and sheath sizes.
  2. Factors to consider in TAVR device selection include: TAVR valve hemodynamics and long-term durability, annular size, aortic valve and aortic root calcification, vascular access and complications, risk of new persistent conduction abnormalities, coronary re-access and risk of coronary occlusion, bicuspid aortic valves, and valve-in-valve TAVR.
  3. TAVR Valve Function and Long-Term Durability: Hemodynamic parameters, including mean gradient (MG), effective orifice area (EOA), and paravalvular leak (PVL) differ among devices. Current literature has shown lower MG and larger EOA in supra-annular self-expanding valves. Long-term durability of TAVR devices beyond 5 or 6 years has not yet been established. Incidence and degree of PVL varies between devices but incidence of moderate and severe PVL have decreased with all current-generation devices, which have incorporated new design features to reduce PVL.
  4. Annular Size: While TAVR devices are available in a range of sizes (as assessed by annular area, perimeter, or diameter), in small annuli a supra-annular valve may result in superior hemodynamics and avoid patient-prosthesis mismatch (PPM). In very large annuli, TAVR devices have been used beyond manufacturer recommendations.
  5. Aortic Valve and Aortic Root Calcification: While TAVR devices require leaflet calcification to anchor in place, in patients with significant annular or left ventricular outflow tract calcification, TAVR may result in significant PVL. Also, heavy calcification has been associated with annular rupture, particularly with oversized valves. In patients with thickened but not calcified leaflets, the JenaValve or J-valve, which affix to the native leaflets by a clipping mechanism, may be ideal.
  6. Vascular Access and Vascular Complications: Smaller sheath size is associated with reduction in bleeding and vascular complications, especially in patients with small femoral artery diameter.
  7. Risk of New Persistent Conduction Abnormalities. Need for new permanent pacemaker implantation (PPI) depends on patient characteristics, valve type, and valve deployment technique. There is “trade-off” between degree of PVL and need for new PPI, as PVL may be reduced by greater radial force of the TAVR device on the annulus, but greater force on the conduction system increases risk of PPI. Device choice and implantation depth may need to be altered for patients with underlying risk factors (right bundle branch block, shorter membranous septal length).
  8. Coronary Re-access and Risk of Coronary Occlusion: Coronary re-access in patients with coronary artery disease (CAD) or who develop CAD is affected by anatomic factors (sinotubular junction dimensions, sinus height, leaflet length and bulkiness, sinus of Valsalva width, and coronary ostial height), device factors (commissural tab orientation, sealing skirt height, device frame height), and procedural factors (deployment depth). Algorithms/apps on coronary re-access for angiography or percutaneous coronary intervention have been developed. In patients at risk for acute coronary obstruction, a retrievable or repositionable TAVR device may be preferable.
  9. Bicuspid Aortic Valve (BAV): In patients with BAV, leaflet asymmetry, presence of a raphe, variable leaflet calcification, left ventricular outflow tract calcification, and sometimes large annular dimensions may hinder optimal TAVR positioning and expansion, resulting in increased risk of PVL. Several propensity-matched studies have shown conflicting data for outcomes of TAVR in bicuspid versus tricuspid AS. There are no data supporting one TAVR device type over another for patients with BAV and AS, but clinical trials are ongoing.
  10. Valve-in-Valve (ViV) TAVR: Optimal device selection for ViV TAVR requires identifying the mechanism of prosthetic valve failure: elevated gradients from structural valve degeneration vs. PPM vs. both. If PPM, ViV TAVR with a self-expanding valve may be more favorable in small bioprosthetic prostheses. Balloon fracture of the stent frame of certain prosthetic valves is an option to facilitate ViV TAVR with a larger device for better EOA. Incidence of acute coronary obstruction in ViV TAVR is higher and careful analysis on TAVR protocol computed tomography scan or 3D models should be performed. BASILICA (Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction During TAVR) or pre-emptive coronary protection are adjunctive techniques.

Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Prevention, Valvular Heart Disease, Atherosclerotic Disease (CAD/PAD), EP Basic Science, Aortic Surgery, Cardiac Surgery and Arrhythmias, Cardiac Surgery and VHD, Interventions and Coronary Artery Disease, Interventions and Imaging, Interventions and Structural Heart Disease, Angiography, Nuclear Imaging

Keywords: Aortic Valve Stenosis, Bundle-Branch Block, Cardiac Surgical Procedures, Coronary Angiography, Coronary Artery Disease, Coronary Occlusion, Heart Valve Diseases, Heart Valve Prosthesis, Hemodynamics, Pacemaker, Artificial, Percutaneous Coronary Intervention, Risk Factors, Secondary Prevention, Sinus of Valsalva, Stents, Tomography, Transcatheter Aortic Valve Replacement, Vascular Diseases

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