From the article cited in the
announcement.......
Comprehensive Echocardiographic Assessment of Normal Transcatheter Valve Function - PubMed (nih.gov)Objectives:This study aims to establish parameters for identifying normal function for each of the 3 iterations of balloon-expandable valves and 2 iterations of self-expanding valves.
Background:Expected transthoracic echocardiographic Doppler-derived hemodynamic data for transcatheter aortic valves inform pre-implant decision-making and post-implanted monitoring of longitudinal valve function.
Methods:We collected the echocardiography core Lab measured mean gradients and effective orifice area (EOA) from discharge or 30-day echocardiograms from randomized trials; the PARTNER (Placement of Aortic Transcatheter Valves) trials for the balloon-expandable valves and the Medtronic CoreValve US Pivotal trial and Medtronic CoreValve Evolut R United States IDE Clinical Study for the self-expanding valves.
Results:For all SAPIEN (Edwards Lifesciences, Irvine, California) valve sizes, mean EOA is 1.70 ± 0.49 cm2 with a mean gradient of 9.36 ± 4.13 mm Hg. For all SAPIEN XT valve sizes, mean EOA is 1.67 ± 0.46 cm2 with a mean gradient of 9.52 ± 3.64 mm Hg. For all SAPIEN 3 valve sizes, the mean EOA is 1.66 ± 0.38 cm2 with a mean gradient of 11.18 ± 4.35 mm Hg. For all CoreValve valve sizes, the mean EOA is 1.88 ± 0.56 cm2 with a mean gradient of 8.85 ± 4.14 mm Hg. For all Evolut R valve sizes, the mean EOA is 2.01 ± 0.65 cm2 with a mean gradient of 7.52 ± 3.19 mm Hg. The SAPIEN 3 post-implant EOA was progressively larger for each quintile of baseline annular area by computed tomography (p < 0.001). Similarly, for the Evolut R valve, post-implantation EOA was significantly larger for each quintile of baseline annular perimeter (p < 0.001).
Conclusions:Tables of expected mean transcatheter aortic valve hemodynamics by valve type and size are essential in evaluating the function of these transcatheter prosthetic valves. Tables of expected EOA by the native annular anatomy may be useful for pre-implantation decision making. Criteria for defining structural valve dysfunction are proposed.
By no means am I down ramping, but the article clearly identifies a product that has similar mechanical (EOA and pressure gradient) performance to the DurARV reported performance.
Yes, the DurARV performance is noticably (if not significantly) different to the results from the Edwards products (Sapien, Sapien XT, Sapien 3) and the Medtronic CoreValve.
However, the Medtronic Evolut R produced results close to those of the DurARV......(2.01 v 2.2, 7.52 v 7.5)........not quite reflective of the EOA of 1.58 and pressure gradient of 11.94 cited in the announcement.......
I am a firm long time believer of the technology and product, however, the reporting here could perhaps have been done with a little more detail and completeness.
