Early clinical and haemodynamic matched comparison of balloon-expandable valves

Abstract

ObjectivesThe balloon-expandable Sapien-3 valve demonstrated superior results in terms of residual aortic regurgitation when compared with self-expandable devices. We aimed to compare for the first-time early outcomes of Sapien-3 transcatheter heart valve (THV) with the balloon-expandable Myval device.MethodsConsecutive real-world patients from nine European institutions with symptomatic severe aortic stenosis treated either with Sapien-3 or Myval THV devices after June 2018 were compared. Early clinical outcomes were prospectively gathered and blinded analysis of 30-day echocardiography was conducted. Matching for the following variables was performed: age, body surface area, Society of Thoracic Surgeons risk score, left ventricular function, mean gradient, transfemoral approach, aortic valvular calcium, aortic annulus mean diameter, area and eccentricity index.ResultsA total of 416 patients treated either with the Sapien-3 (n=286, 68.7%) or with Myval THV (n=130, 31.3%) were included and 103 pairs compared after matching. Baseline characteristics were similar. Procedural success rate (Sapien-3: 94.2%; Myval: 93.2%, p=0.219), 30-day mortality (Sapien-3: 2.9%; Myval: 0.97%, p=0.625), clinical efficacy (12.6 vs 4.9%, p=0.057) and early safety (12.6 vs 4.9%, p=0.096) were comparable. There was a lower need for new permanent pacemaker (15.5 vs 5.8% p=0.020) with Myval. No significant differences were found in terms of ≥moderate aortic regurgitation (1% for Sapien-3, 0% for Myval, p=0.314), but mean gradients were higher following Sapien-3 than after Myval (p<0.001).ConclusionsThe new Myval balloon-expandable THV was favourable in terms of safety, with low rate of permanent pacemaker and with favourable residual gradients and paravalvular leak rate according to blinded echocardiographic analysis.

Next‐generation balloon‐expandable Myval transcatheter heart valve in low‐risk aortic stenosis patients

“…Moreover, the use of intermediate‐sized prosthesis might help to prevent aortic annular excessive overexpansion potentially reducing risk of rupture. These finding are in agreement with preliminary reports suggesting no difference in terms of residual moderate or severe AR (Myval: 0.8%, Sapien 3: 2.5%, p = 0.625) and lower transvalvular mean gradients following Myval (Myval: 9 ± 4.7 mm Hg, Sapien 3: 12.1 ± 5.3 mmHg, p < 0.001), as well as a lower rate of permanent pacemaker (7.4 vs. 14.8%, p = 0.042) 6 . Both, hemodynamics and conduction disturbances rate are part of the primary composite endpoint of the ongoing LANDMARK trial that will recruit 768 patients allocated in a 1:1 randomization to Myval, Sapien, or Evolut THV series 9 .…”

“…The balloon‐expandable (BE) Myval transcatheter heart valve (THV) is a new device with initial positive reports for the treatment of intermediate and high‐risk AS patients 3 . Results from MYVAL‐1 study include a 1‐year all‐cause mortality of 13% and a rate of new pacemaker of 2%, 4 and more recent research comparing alternative balloon expandable devices suggest favorable residual aortic regurgitation (AR) rate, 5 adequate residual gradients, similar mortality, and persistent lower rate of pacemaker need 6 . However, unlike more‐frequently used self‐expandable (SE) and BE TAVR systems, little is known on the outcomes of the Myval THV in low‐surgical risk patients.…”

Clinical Comparison of a Novel Balloon-Expandable Versus a Self-Expanding Transcatheter Heart Valve for the Treatment of Patients with Severe Aortic Valve Stenosis: The EVAL Registry

“…Additionally, such profile of efficacy, with a particularly low rate of PPI and hemodynamically significant PVL, was also confirmed when compared with the most commonly used cobalt chromium BE THVs. Notably, in the first comparison of the Sapien-3 and the Myval THV in a case-matched population, the use of a nickel-cobalt frame was associated with favorable short-term early safety and clinical efficacy, along with a better transvalvular gradient, similar residual PVL and a lower PPI rate [22,23].…”

Quantitative Angiographic Assessment of Aortic Regurgitation Following 11 TAVR Devices: An Update of a Multicenter Pooled Analysis

“…7,30 The outstanding performance of the Myval THV in comparison to the other available BEVs is in line with the result of other studies. 31,32 Likewise, the Chinese valves, VitaFlow and Venus-A, have acceptable results even in Chinese patients with their more challenging anatomy such as high calcification and bicuspid anatomy. 28 VitaFlow and Venus-A are SEVs and have received China Food and Drug Administration approval and are used in daily clinical practice in China.…”