Andreas Rück

@DFCapodanno The new ACURATE Prime had excellent results as we showed in the Early ACURATE Prime registry at EuroPCR. The previous gen ACURATE neo2 was equivalent to other TAVI in Swedish registry data at 1 year, shown at CRT, and in other European studies. It just needed a little finesse.

In the field of interventional cardiology, today’s news is that Boston Scientific Corporation has announced the discontinuation of global sales of its ACURATE neo2™ and ACURATE Prime™ aortic valve systems. Over the years, various iterations of this valve have been evaluated in three randomized trials, all of which failed to meet noninferiority endpoints. One of them was our own SCOPE-2 trial, published in 2020, in which the ACURATE neo1 narrowly missed the noninferiority margin (P=0.0549). Even then, early concerns were already evident. There was hope that the second-generation neo2 would address these limitations. It is regrettable—the device featured a refined delivery mechanism, and the pacemaker rate was acceptable for a self-expanding valve—but the rate of residual paravalvular leak remained higher than with competing devices. Moreover, the results of the recent ACURATE IDE trial were particularly concerning. So be it—on to the next.

@bostonsci @KarolinskaUnsju @TAVRBot @PCRonline @GilbertTangMD

Early ACURATE Prime 30d data today at #EuroPCR2025. 517 ACURATE #TAVI at 12 EU sites. Postdil done in 50%. 30d echo only 1.2% PVL, mean gradient 7 mmHg. Mortality 0.4%, new pacemaker 9.8%. This device clearly works. We will provide frame expansion data and longer FUP later.

Prime results in the Early ACURATE Prime registry! 30d results at HOTLINE TAVI2 session tomorrow at #EuroPCR. Room 242AB at 0945. 517 all-comer #TAVI cases from 12 EU sites enrolled in 6 months, clinical outcomes + core lab echo at 30 days will be shown. @TAVRBot @GilbertTangMD

TAVI possible? @GilbertTangMD @TAVRBot @tavrkapadia @JoaoLCavalcante @bapat_savrtavr

Calcium shelf in front of left main. #TAVI CT. Have you seen this before? Angiogram not done yet, left main may be occluded. #TAVR possible?

181 bicuspid #TAVR with Acurate neo2: only 4% moderate PVL, mean gradient 6 mmHg, new pacemaker 6%. Read the paper at @EuroInterventio. @dmylotte @MSettergren

Just published on the occasion of #PCRLV: The Neo2 BAV registry evaluated the safety and efficacy of ACURATE neo2 in patients with BAV stenosis. @kiadeb87 asked first author @AndreasRck2 to share insights on the study⬇️

@GilbertTangMD I am still worried about longer term downsides with prosthesis in tricuspid: thrombus, gradient. My guess is that Tricuspid TEER will dominate the market, when used w 3D IntraCardiac Echo. Also a safer procedure.

#Evoque #TTVR #TRISCEND2 RCT showed no diff in ☠️HFH but ⬆️KCCQ 6MWD. Landmark analysis showed trend in ⬇️☠️in TTVR but not powered. Papers now in @NEJM @JACCJournals #TCT2024 @crfheart @hahn_rt @SusheelKodaliMD

@KarolinskaUnsju @GilbertTangMD @RodrigoBagur @J_Sathananthan

Karolinska fist to reach 25 #tavi with the new ACURATE Prime. Very promising results also in challenging cases. ⬆️ radial force seems to make a difference. The multicenter registry "Early ACURATE Prime" will present 500 cases 2025, contact us to join. @TAVRBot @bostonsci

@DFCapodanno The study result was almost entirely driven by TAVR within 6 mo in the conservative arm, which was included as unplanned hospitalization (!). That's why the curves look so strange with the inflection point at 6 mo. Not sure this is enough to tilt the guidelines.

EARLY TAVR published. Among patients with asymptomatic severe aortic stenosis, a strategy of early TAVR was superior to clinical surveillance in reducing the incidence of death, stroke, or unplanned hospitalization for cardiovascular causes, driven by the latter. The study's findings may be limited by factors such as its unavoidable unblinded nature, trial-specific vigilance levels, low-risk patient selection, and use of a single valve type. #TCT2024 nejm.org/doi/full/10.10…

@finnakerstrom @TAVRBot Not visible on fluoro… Large atria so might be hard to achieve sinus rythm?

@AndreasRck2 @TAVRBot What about AFib ablation?

Crowded heart! Can you name the devices and their location? #tavr @TAVRBot

@colum_owens @KarolinskaUnsju @BSCCardiology @TAVRBot Start with marker, then check upper crown vs leaflets after step 1A. Implant depth usually 4-5 mms in these. Check PCR London Valves for bicuspid study

@AndreasRck2 @KarolinskaUnsju @BSCCardiology @TAVRBot For bicuspid do you use the marker or upper crown interaction with the valve leaflets?

4 x ACURATE Prime #tavi at @KarolinskaUnsju today. 2x Bicuspid, 1x hostile access, 1x heavily calcified leaflets. Good result in all. Updated device with super-fast final release and ⬆️ radial strength. @BSCCardiology @TAVRBot Simultaneous start at 5 EU sites today

@kspargias @TAVRBot Full points!

@AndreasRck2 @TAVRBot Accurate in AV, metallic tilted disc in MV and 2 Pascal ACEs in TV and an ICE probe in RA. Well done 👍

Reference: sciencedirect.com/science/articl… @GilbertTangMD @GreggWStone @TAVRBot @NatalieGlaser10 @MSettergren @MichaelDismorr

SEX STUDY! Women do better after #TAVI than men. 10000+ patient @RealSwedeheart study. Better survival and fewer bleedings, mean 3 years FUP. Statistics: regression standardization. SAVR is not better in women than men. SAVR/#TAVR should be decided based on sex too!

Would you do PCI for this TAVI patient (2)? 75 yr old, 90% LAD stenosis, sometimes chest pain, normal LVEF, high gradient AS Vmax 5 m/s @GilbertTangMD @MGtberg @phillipfreeman @NEJM

Would you do PCI for this TAVI patient (1)? 85 yr old, 80% calcified long stenosis RCA, no chest pain, normal LVEF, high gradient AS Vmax 5 m/s

Preventive PCI for #TAVI patients? NOTION3 trial shows that PCI (63% was LAD, 80% single vessel, 74% before TAVI)⬇️myocardial infarction and urgent revasc, but same mortality over 2 yr FUP. 45% w/o angina before PCI+TAVI, CCS/NYHA post-TAVI same. nejm.org/doi/full/10.10…