Mechanically-expanding valve Lotus Edge was discontinued worldwide, as recently informed by its manufacturer, Boston Scientific. This is a voluntary recall of all Lotus valve inventory, and the immediate suspension of the program. The United States Food and Drug Administration (FDA) approved Lotus Edge in 2019 for patients with severe aortic stenosis and high surgical risk.…
Balloon-Expandable Valve Outdoes Itself
The objective of this paper recently published in J Am Coll Cardiol Intv was to compare the outcomes of transcatheter aortic valve replacement (TAVR) with the new Sapien 3 Ultra vs. Sapien 3. Successful implantation was extremely high with both balloon-expandable devices, which also had a very low adverse event rates. However, Sapien Ultra was significantly better…
AHA 2020 | Post-TAVR Anticoagulation in Patients with Atrial Fibrillation
Direct anticoagulant agents were associated with lower long-term mortality in patients with atrial fibrillation discharged after successful transcatheter aortic valve replacement (TAVR) compared with classic vitamin K inhibitors. Optimal anticoagulation in patients with atrial fibrillation (AF) undergoing TAVR is unclear. We are actually just starting to know what the ideal antiplatelet therapy is for patients undergoing…
AHA 2020 | Rise in Early Discharge After TAVR Has the Expected Cost
As hospitalization time after a transcatheter aortic valve replacement (TAVR) is reduced, we are observing a concomitant increase in re-hospitalizations due to conduction disorders. Early discharge is a great step, but it should be noted that conduction disorders can happen beyond 48 hours. A few years ago, pacemaker implantation rates after discharge were about 7%;…
Asymptomatic Severe Aortic Stenosis, When Should We Intervene?
Data from recent observational randomized studies suggest that most patients with asymptomatic severe aortic stenosis will eventually receive an indication for valve replacement. Mortality in this “asymptomatic” population is caused not only by sudden death, but also by cardiac death. Early intervention may prevent these deaths as a consequence of aortic stenosis symptoms. Researchers…
Conscious Versus General Anesthesia in TAVR
Patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) can safely undergo the procedure under conscious sedation. Conscious sedation has been adopted in clinical practice as a natural way of simplifying and conducting the procedure in the least invasive way possible. Currently, up to 50% of patients undergo TAVR under conscious sedation, but…
TCT 2020 | TAVR Appears to Be the Solution for All Dysfunctional Biological Valves
Transcatheter aortic valve replacement (TAVR) results durable at 5 years to treat failed surgical bioprosthetic valves and at one year to treat valves percutaneously. Regardless the type of the failed valve, the solution is TAVR. The 5 year follow up of the PARTNER 2 valve-in-valve (ViV) showed that TAVR as treatment for failed surgical bioprosthetic…
TCT 2020 | Surprising Differences in Stroke between SAPIEN 3 and Evolut R
One-year outcomes of the head to head trial between CoreValve Evolut R vs Sapien 3 showed a significantly higher difference in stroke vs. patients receiving the self-expanding valve (Sapien 3 6.9% vs Evolut R 1%; p=0.002). The SOLVE-TAVI randomized 2×2 patients with severe aortic stenosis and high surgical risk to Sapien 3 or Evolut R and…
TCT 2020 | Efficacy of Cerebral Protection Device TriGUARD 3 During TAVR
Cerebral protection device TriGUARD 3, designed to cover all supra-aortic vessels during transcatheter aortic valve replacement (TAVR), is safe to use, according to the outcomes of the REFLECT II study. The technical feasibility of the device, which requires transfemoral access, does not seem to have an impact over clinical events. The primary safety endpoint was a VARC-2-defined…
TCT 2020 | Acurate Neo Does Not Meet Non-Inferiority vs. CoreValve Evolut
The self-expanding Acurate Neo (Boston Scientific) did not meet non-inferiority vs. the self-expanding CoreValve Evolut (Medtronic) in the SCOPE 2 study published in Circulation simultaneously and presented at the virtual TCT 2020. These are bad news for the Acurate Neo, that had already failed to show non-inferiority vs. the Sapien 3 in the SCOPE 1…
Death, Stroke, and Hospitalization while Waiting for TAVR
The consequences of deferring transcatheter aortic valve replacement (TAVR) procedures because of the COVID 19 pandemic are piling up. Untreated severe aortic stenosis patients who had been scheduled for TAVR are seeing increased risk of all events, even mortality. According to recent studies published in JAMA, deferring TAVR in patients with symptomatic aortic stenosis is…