ACURATE neo2 Transcatheter aortic valve implantation without balloon aortic valvuloplasty - direct ACURATE neo2.

BACKGROUND: ACURATE neo2 (Neo2) implantation is performed after systematic Balloon Aortic Valvuloplasty (BAV) in most patients. No reports exist about the feasibility and safety of direct Neo2 transcatheter aortic valve implantation (TAVI) in comparison to the standard practice. AIM: We aimed to identify the patients' baseline anatomical characteristics, procedural, and early post-procedural outcomes in patients treated using Neo2 with and without BAV. METHODOLOGY: This is a retrospective multicentre analysis of 499 patients with severe aortic stenosis who underwent TAVI using Neo2. The comparison was done according to the performance or omission of BAV. Echocardiography and computed tomography were analysed by an independent Core Lab. Propensity score matching (PSM) was performed based on the annular diameter and AV calcium volume, which identified 84 matched pairs. RESULTS: Among the cohort included, 391 (78%) patients received BAV (BAV-yes) and 108 (22%) were not attempted (BAV-no or Direct TAVI). Patients in BAV-no cohort had smaller annular diameter (22.6 vs 23.4 mm; p < 0.001) and lower calcium volume (163 vs 581 mm3; p < 0.001) compared to BAV-yes cohort. In the matched cohort, VARC-3 device technical success was similar (95%) and all other outcome measures were statistically comparable between cohorts. CONCLUSION: Direct TAVI using ACURATEneo2 without pre-TAVI balloon aortic valvuloplasty in patients with mild or less valve calcifications might be feasible and associated with comparable early outcomes compared to patients with similar anatomical features undergoing systematic balloon valvuloplasty.

Multicenter comparison of transcatheter aortic valve implantation with the self-expanding ACURATE neo2 versus Evolut PRO transcatheter heart valves.

BACKGROUND: New-generation self-expanding transcatheter aortic heart valves (THV) were designed to overcome technical constraints of their preceding generations. We sought to compare the efficacy and safety of the self-expanding ACURATE neo2 (Neo2) versus Evolut PRO (PRO) devices. METHODS: Seven hundred nine patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) with either Neo2 (n = 496) or PRO (n = 213) were included. Propensity score matching (PSM) was performed to account for differences in baseline characteristics. In-hospital and 30-day clinical outcomes were evaluated according to Valve Academic Research Consortium-3 criteria. RESULTS: Baseline characteristics were comparable between both groups after PSM (Neo2: n = 155, Evolut Pro: n = 155). Technical success rates were high in both groups (Neo2: 94.8% vs PRO: 97.4%; p = 0.239). Need for permanent pacemaker implantation was less frequent with Neo2 compared with PRO (7.5% vs 20.6%; p = 0.002), whereas major vascular complications were more frequent with Neo2 (Neo2: 11.6% vs PRO: 4.5%; p = 0.022). Intended valve performance at discharge was high in both groups without relevant differences among groups (Neo2: 97.4% vs. 95.3%; p = 0.328). CONCLUSIONS: Short-term outcomes after TAVI using latest-generation self-expanding THV were excellent, with overall low rates of adverse events. However, Neo2 was associated with lower pacemaker rates and reduced the prevalence of moderate-severe paravalvular leakage. Transprosthetic gradients after TAVI were higher with Neo2 compared with PRO.

The Early neo2 Registry: Transcatheter Aortic Valve Implantation With ACURATE neo2 in a European Population.

Background ACURATE neo2 is a transcatheter aortic valve implantation system consisting of a self-expanding bioprosthetic valve with supra-annular leaflet position and featuring innovations to facilitate placement accuracy and reduce paravalvular regurgitation. Methods and Results The goal of the Early neo2 (Early neo2 Registry of the ACURATE neo2 TAVI Prosthesis) was to gather real-life data on safety and efficacy in a European transcatheter aortic valve implantation population treated with ACURATE neo2. Data were collected from 554 consecutive patients treated with ACURATE neo2 at 12 European sites (mean age, 82 years; 66% women; mean European System for Cardiac Operative Risk Evaluation II, 4.5%±3.8%) between September 2020 and March 2021. The composite primary end point was the occurrence of any of the following: postoperative (in-hospital) paravalvular regurgitation grade ≥2, in-hospital acute kidney injury stage 3, postoperative pacemaker implantation, 30-day death, and 30-day stroke. The primary end point occurred in 12.6% of patients. The 30-day rates for all-cause death and all stroke were 1.3% and 2.7%, respectively, and 1.5% of patients exhibited stage 3 acute kidney injury. A total of 34 patients (6.2%) received a postoperative permanent pacemaker. Per core laboratory-adjudicated echocardiographic analysis, mean postoperative aortic valve gradient was 7.6±3.3 mm Hg, and 2.8% of patients exhibited paravalvular regurgitation grade ≥2. Conclusions In this report of postmarket use of the ACURATE neo2 valve in a real-world transcatheter aortic valve implantation population, patients exhibited favorable postoperative hemodynamics and clinical outcomes and a low rate of postoperative pacemaker implantation.

ACURATE neo2 versus SAPIEN 3 Ultra for transcatheter aortic valve implantation.

BACKGROUND: No comparative data exist with the latest generation self-expanding ACURATE neo2 (Neo2) and the balloon-expandable SAPIEN 3 Ultra (Ultra) transcatheter heart valves (THV). AIMS: We aimed to compare the outcomes after transcatheter aortic valve implantation (TAVI) using the Neo2 and the Ultra THV. METHODS: A total of 1,356 patients at 4 centres were treated either with the Neo2 (n=608) or the Ultra (n=748). The primary endpoint was device success according to the latest Valve Academic Research Consortium definitions. The association of the THV used and the primary endpoint was assessed using inverse probability treatment weighting (IPTW) and 1:1 propensity score matching (PSM), which identified 472 matched pairs.  Results: After PSM, there were no relevant differences between the groups. While rates of moderate to severe paravalvular leakage (PVL) were overall low (0.6% vs 1.1%; p=0.725), elevated transvalvular gradients (≥20 mmHg) were less frequent with the Neo2 (2.4% vs 7.7%; p<0.001), which translated into a significantly higher rate of device success with the Neo2 compared with the Ultra (91.9% vs 85.0%; p<0.001). Consistently, the Neo2 was associated with higher rates of device success in the IPTW analysis (odds ratio [OR] 1.961, 95% confidence interval [CI]: 1.269-3.031; p=0.002). Rates of mild PVL were significantly lower with the Ultra compared with the Neo2 (20.0% vs 32.8%; p<0.001). Clinical events at 30 days were comparable between the 2 groups. CONCLUSIONS: Short-term outcomes after TAVI using the Neo2 or Ultra THV were excellent and, overall, comparable. However, transvalvular gradients were lower with the Neo2, which translated into higher rates of device success. Rates of mild PVL were significantly lower with the Ultra THV.

Recovery From Eccentric Squat Exercise in Resistance-Trained Young and Master Athletes With Similar Maximum Strength: Combining Cold Water Immersion and Compression.

The aim of this study was to investigate whether recovery from eccentric squat exercise varies depending on age and to assess whether the use of a mixed-method recovery (MMR) consisting of cold water immersion and compression tights benefits recovery. Sixteen healthy and resistance-trained young (age, 22.1±2.1years; N=8) and master male athletes (age, 52.4±3.5years; N=8), who had a similar half squat 1-repetition maximum relative to body weight, completed two identical squat exercise training sessions, separated by a 2-week washout period. Training sessions were followed by either MMR or passive recovery (PR). Internal training loads [heart rate and blood lactate concentration (BLa)] were recorded during and after squat sessions. Furthermore, maximal voluntary isometric contraction (MVIC) force, countermovement jump (CMJ) height, resting twitch force of the knee extensors, serum concentration of creatine kinase (CK), muscle soreness (MS), and perceived physical performance capability (PPC) were determined before and after training as well as after 24, 48, and 72h of recovery. A three-way mixed ANOVA revealed a significant time effect of the squat protocol on markers of fatigue and recovery (p<0.05; decreased MVIC, CMJ, twitch force, and PPC; increased CK and MS). Age-related differences were found for BLa, MS, and PPC (higher post-exercise fatigue in younger athletes). A significant two-way interaction between recovery strategy and time of measurement was found for MS and PPC (p<0.05; faster recovery after MMR). In three participants (two young and one master athlete), the individual results revealed a consistently positive response to MMR. In conclusion, master athletes neither reach higher fatigue levels nor recover more slowly than the younger athletes. Furthermore, the results indicate that MMR after resistance exercise does not contribute to a faster recovery of physical performance, neuromuscular function, or muscle damage, but promotes recovery of perceptual measures regardless of age.

QRS-T angle in patients with Hypertrophic Cardiomyopathy - A comparison with Cardiac Magnetic Resonance Imaging.

Objective: We sought to investigate the possible association of a wide QRS-T angle on the surface EKG and myocardial fibrosis on contrast-enhanced cardiovascular magnetic (CMR) imaging in patients with hypertrophic cardiomyopathy (HCM). Background: Risk stratification in HCM patients is challenging. Late gadolinium enhancement (LGE) visualizes myocardial fibrosis with unique spatial resolution and is a strong and independent prognosticator in these patients. The QRS-T angle from the surface EKG is a promising prognostic marker in various cardiac pathologies. Methods: 70 patients with HCM obtained a standardized digital 12-lead EKG for the calculation of the QRS-T angle and underwent comprehensive CMR imaging for visualization of fibrosis by LGE. Patients were divided into groups according to the absence or presence of fibrosis on CMR. Results: 43 of 70 patients with HCM showed LGE on CMR following contrast administration. HCM patients with LGE (fibrosis) had wider QRS-T angles as compared to the patient group without LGE (100±54 vs. 46±31; <0.001). A QRS-T angle of 90 degrees or more was a strong predictor (OR 32.84, CI 4.08-264.47; p <0.001) of HCM with LGE. Conclusion: There is a strong association of a wide QRS-T angle and myocardial fibrosis in patients with HCM.