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The ACURATE neo2 (NEO2) and Evolut PRO/PRO+ (PRO) bioprostheses are new-generation self-expanding valves developed for transcatheter aortic valve replacement (TAVR).We sought to compare the performance of the ACURATE neo2 and Evolut PRO/PRO+ devices.The NEOPRO-2 registry retrospectively included patients who underwent TAVR for severe aortic stenosis with either the NEO2 or PRO devices between August 2017 and December 2021 at 20 centres. In-hospital and 30-day Valve Academic Research Consortium (VARC)-3 defined outcomes were evaluated. Propensity score (PS) matching and binary logistic regression were performed to adjust the treatment effect for PS quintiles. A subgroup analysis assessed the impact of aortic valve calcification.A total of 2,175 patients (NEO2: n=763; PRO: n=1,412) were included. The mean age was 82±6.2 years and the mean Society of Thoracic Surgeons score was 4.2%. Periprocedural complications were low, and both groups achieved high rates of technical success (93.1% vs 94.1%; p=0.361) and predischarge intended valve performance (96.0% vs 94.1%; p=0.056), both in the unmatched and matched analysis (452 pairs). Device success at 30 days was comparable (84.3% vs 83.6%; p=0.688), regardless of aortic valve calcification severity (p0.05 for interaction). A suggestion for higher VARC-3 early safety in the NEO2 group was mainly driven by reduced rates of new permanent pacemaker implantation (7.7% vs 15.6%; p0.001).This retrospective analysis reports a similar short-term performance of the ACURATE neo2 platform compared with the new-generation Evolut PRO/PRO+ devices. Randomised studies are needed to confirm our exploratory findings.

BACKGROUND Bioprosthetic valve fracture (BVF) is a technique to reduce gradients in valve-in-valve transcatheter aortic valve implantation (VIV-TAVI) procedures. The outcome of VIV-TAVI with BVF has not been compared with VIV-TAVI without BVF. AIMS The aim of this study was to evaluate the outcome of VIV-TAVI with BVF compared to VIV-TAVI without BVF. METHODS In total, 81 cases of BVF VIV-TAVI (BVF group) from 14 centres were compared to 79 cases of VIV-TAVI without BVF (control group). RESULTS VARC-2-defined device success was 93% in the BVF group and 68.4% in the control group (p

Objectives The aim of this study was to determine clinical and echocardiographic characteristics, mechanisms of failure, and outcomes of mitral valve (MV) surgery after transcatheter edge-to-edge repair (TEER). Background Although >100,000 mitral TEER procedures have been performed worldwide, longitudinal data on MV surgery after TEER are lacking. Methods Data from the multicenter, international CUTTING-EDGE registry were retrospectively analyzed. Clinical and echocardiographic outcomes were evaluated. Median follow-up duration was 9.0 months (interquartile range [IQR]: 1.2-25.7 months) after MV surgery, and follow-up was 96.1% complete at 30 days and 81.1% complete at 1 year. Results From July 2009 to July 2020, 332 patients across 34 centers underwent MV surgery after TEER. The mean age was 73.8 ± 10.1 years, median Society of Thoracic Surgeons risk for MV repair at initial TEER was 4.0 (IQR: 2.3-7.3), and primary/mixed and secondary mitral regurgitation were present in 59.0% and 38.5%, respectively. The median interval from TEER to surgery was 3.5 months (IQR: 0.5-11.9 months), with overall median Society of Thoracic Surgeons risk of 4.8% for MV replacement (IQR: 2.8%-8.4%). The primary indication for surgery was recurrent mitral regurgitation (33.5%), and MV replacement and concomitant tricuspid surgery were performed in 92.5% and 42.2% of patients, respectively. The 30-day and 1-year mortality rates were 16.6% and 31.3%, respectively. On Kaplan-Meier analysis, the actuarial estimates of mortality were 24.1% at 1 year and 31.7% at 3 years after MV surgery. Conclusions In this first report of the CUTTING-EDGE registry, the mortality and morbidity risks of MV surgery after TEER were not negligible, and only

Background Permanent pacemaker implantation (PPI) remains one of the main drawbacks of transcatheter aortic valve replacement (TAVR), but scarce data exist on PPI after valve-in-valve (ViV) TAVR, particularly with the use of newer-generation transcatheter heart valves (THVs). Objectives The goal of this study was to determine the incidence, factors associated with, and clinical impact of PPI in a large series of ViV-TAVR procedures. Methods Data were obtained from the multicenter VIVID Registry and included the main baseline and procedural characteristics, in-hospital and late (median follow-up: 13 months [interquartile range: 3 to 41 months]) outcomes analyzed according to the need of periprocedural PPI. All THVs except CoreValve, Cribier-Edwards, Sapien, and Sapien XT were considered to be new-generation THVs. Results A total of 1,987 patients without prior PPI undergoing ViV-TAVR from 2007 to 2020 were included. Of these, 128 patients (6.4%) had PPI after TAVR, with a significant decrease in the incidence of PPI with the use of new-generation THVs (4.7% vs. 7.4%; p = 0.017), mainly related to a reduced PPI rate with the Evolut R/Pro versus CoreValve (3.7% vs. 9.0%; p = 0.002). There were no significant differences in PPI rates between newer-generation balloon- and self-expanding THVs (6.1% vs. 3.9%; p = 0.18). In the multivariable analysis, older age (odds ratio [OR]: 1.05 for each increase of 1 year; 95% confidence interval [CI]: 1.02 to 1.07; p = 0.001), larger THV size (OR: 1.10; 95% CI: 1.01 to 1.20; p = 0.02), and previous right bundle branch block (OR: 2.04; 95% CI: 1.00 to 4.17; p = 0.05) were associated with an increased risk of PPI. There were no differences in 30-day mortality between the PPI (4.7%) and no-PPI (2.7%) groups (p = 0.19), but PPI patients exhibited a trend toward higher mortality risk at follow-up (hazard ratio: 1.39; 95% CI: 1.02 to 1.91; p = 0.04; p = 0.08 after adjusting for age differences between groups). Conclusions In a contemporary large series of ViV-TAVR patients, the rate of periprocedural PPI was relatively low, and its incidence decreased with the use of new-generation THV systems. PPI following ViV-TAVR was associated with a trend toward increased mortality at follow-up.

OBJECTIVE To evaluate the risk for brain lesions in valve in valve (VIV)-transcatheter aortic valve replacement (TAVR) compared to native valve procedures (NV-TAVR). BACKGROUND TAVR is associated with the risk of stroke and a high incidence of brain lesions in diffusion-weighted magnetic resonance imaging (DW-MRI). The risk in VIV procedures is unknown. METHODS Patients were included, if they received a Sapien-3 or an Evolut-R valve for an NV-TAVR or VIV-TAVR and a DW-MRI within 3-5 days after the procedure. RESULTS Two hundred nine patients had NV-TAVR and 41 patients had VIV-TAVR. The VIV group was significantly younger (mean 82.3 vs. 74.7 years old, p

Background Late Stanford type A aortic dissections (TAADs) are a very rare complication after transcatheter aortic valve implantation (TAVI). Surgery is the treatment of choice, but perioperative mortality (25%) and neurological complications (18%) remain high. Case summary An 85-year-old male patient presented with acute chest pain 5 months after a transfemoral Evolut R 34 mm transcatheter heart valve (THV) implantation. On multi-slice computed tomography (MSCT) a TAAD was found with a 7 mm primary entry at the supra-annular aortic edge of the THV expanding to the innominate artery without re-entry. Due to extensive comorbidities including two bypass operations in the history, the Heart Team declined surgery. Within 6 months of watchful waiting the maximal aortic diameter (MAD) increased from 57 to 62 mm. The decision was made to perform an endovascular closure of the inflow to the false lumen by implanting a 25 mm Amplatzer™ Cribriform Septal Occluder. MSCT 4 weeks after occlusion showed the false lumen almost completely filled with thrombus, MSCT 3 months later showed a MAD reduction to 55 mm with shrinkage of the false lumen. Discussion Presumably, the late TAAD was caused by the supra-annular edge of the Evolut-stent. Because of the extreme risk surgical repair was not an option and a stent graft would have occluded the vein grafts. This case shows that in absence of any other treatment options endovascular closure of the entry to the false lumen can be successfully performed in a TAAD after TAVI.

OBJECTIVES To evaluate outcome and its predictors of bioprosthetic valve fracture (BVF) in patients undergoing valve-in-valve transcatheter aortic valve replacement (VIV-TAVR). BACKGROUND BVF is feasible and reduces transvalvular gradients in VIV-TAVR-procedures, but follow-up-data and information on factors influencing the outcome are missing. METHODS The 81 cases of BVF-VIV-TAVR were collected from 14 international centers. RESULTS Predominantly transcatheter heart valve (THV) was implanted first, followed by BVF. VARC-2 defined device success was 93%, most failures were attributed to residual high gradients. Mean gradients decreased from 37��������13���mmHg to 10.8��������5.9���mmHg (p��

The Direct Flow Medical® (DFM) Valve (Direct Flow Medical Inc., Santa Rosa, CA) is a nonmetallic transcatheter heart valve (THV) which was approved in Europe in October 2014 for the treatment of ao...

AIMS The aim of this study was to determine the feasibility of rotational atherectomy (RA) in chronic total occlusion (CTO) PCI and compare the success and complication rates of RA in CTO lesions versus non-occluded lesions. Data on RA in CTO are rare and it is unknown how procedural success and risk of RA in CTO lesions compare to RA in non-CTO lesions. METHODS AND RESULTS RA was performed in 392 out of 17,919 PCI procedures (2.2% of the PCI cohort) and classified as RA CTO (n=75) and RA non-CTO (n=317). Procedural success and MACCE in both groups were assessed by two investigators. All RA procedures were analysed for dissections prior to RA, which were defined according to the NHLBI classification. Baseline characteristics were not significantly different in the two groups but, in RA CTO, lesion type was more complex (p

Recently published 30-day all-stroke data from PARTNER 3 (SAPIEN vs. surgery) and the EVOLUT LOW RISK trial (Evolut vs. surgery) revealed a lower stroke rate with the balloon-expandable valve (0.6% vs. 3.4%). A head-to-head comparison of both valve types regarding stroke, however, is not available.

A significant number of patients (pts) after surgical aortic valve replacement (SAVR) show prosthesis-patient mismatch (PPM), which increases mortality. Bioprosthetic valve fracture (BVF) reduces residual gradients after valve-in-valve transcatheter aortic valve replacement (VIV-TAVR).Our aim was to

Transcatheter aortic valve replacement (TAVR) is associated with the risk of embolic stroke and of diffusion-weighted magnetic resonance imaging (DW-MRI) lesions. The embolic risk in valve in valve procedures (VIV-TAVR) is uncertain. This study aimed to evaluate the risk for brain lesions after TAVR