ACURATE Neo Transcatheter Heart Valve Research Articles

In-Series Transcatheter Aortic Valve Replacement-in-Transcatheter Aortic Valve Replacement: ACURATE neo Transcatheter Heart Valve Degeneration Successfully Managed with Myval, Avoiding Coronary Flow Obstruction—A Case Report

•Durability is vital for transcatheter aortic valve replacement in younger patients.•Aortic insufficiency is one of the features of structural valve degeneration.•Degenerated ACURATE neo can be treated with low implantation of an oversized Myval.

Impact of Commissural Misalignment onHydrodynamic Function Following Valve-in-Valve Intervention With the ACURATE neo.

Limited evidence is available regarding valve-in-valve (VIV) intervention with the ACURATE neotranscatheter heart valve (THV). Low implantation has demonstrated leaflet interaction between the surgical bioprosthesis and the THV, leading to impaired hydrodynamic performance. It is unknown if commissural alignment (CA) can affect this phenomenon. Novel techniques have now been developed to achieve CA with the ACURATE neoTHV. The aim of this study was to assess the impact of commissural misalignment (CMA) on hydrodynamic function following VIV intervention with the ACURATE neo THV using a bench model. VIV intervention was performed with the ACURATE neo (a self-expanding THV with supra-annular leaflet position) implanted deep in the surgical bioprosthetic aortic valve (Mitroflow). Hydrodynamic function at CA (0°) and 3different degrees of CMA (30°, 60°, and 90°) was tested. As per the International Organization for Standardization, a regurgitant fraction<20% is considered optimal. Following VIV, the central THV regurgitant fraction at 0°, 30°, 60°, and 90° of CMA was 8.6% ± 2.0%, 30.3% ± 12.0%, 42.6% ± 11.9%, and 66.7% ± 25.4% (P< 0.0001), respectively. On high-speed video there was no evidence of leaflet interaction at CA, whereas at 30°, 60°, and 90° of CMA there was clear evidence of THV leaflet interaction with those of the surgical valve, leading to impaired leaflet closure and to severe central THV regurgitation. In VIV using the ACURATE neo THV at deep implantation, increasing degree of CMA was associated with THV leaflet interaction with those of the surgical valve and worsening regurgitant fraction. THV leaflet interaction was prevented when there was CA.

Rationale and Design of the Project to Look for Early Discharge in Patients Undergoing TAVR With ACURATE (POLESTAR Trial)

BackgroundTranscatheter aortic valve replacement (TAVR) is now an established treatment strategy for elderly patients with symptomatic aortic stenosis (AS) across the entire operative risk spectrum. Streamlined TAVR protocols along with reduced procedure time and expedited ambulation promote early hospital discharge. Selection of patients suitable for safe early discharge after TAVR might improve healthcare efficiency. Study designThe POLESTAR trial is an international, multi-center, prospective, observational study which aims to evaluate the safety of early discharge in selected patients who undergo TAVR with the supra-annular functioning self-expanding ACURATE Neo transcatheter heart valve (THV). A total of 250 patients will be included based on a set of baseline criteria indicating potential early discharge (within 48 h post-TAVR). Primary study endpoints include Valve Academic Research Consortium (VARC)-3 defined safety at 30 days and VARC-3 defined efficacy at 30 days and 1 year. Endpoints will be compared between early discharge and non-early discharge cohorts with a distinct landmark analysis at 48 h post-TAVR. Secondary endpoints include quality of life assessed using EQ5D-5L and Kansas City Cardiomyopathy Questionnaire (KCCQ) questionnaires and resource costs compared between discharge groups. SummaryThe POLESTAR trial prospectively evaluates safety and feasibility of an early discharge protocol for TAVR using the ACURATE Neo THV.

Transcatheter Aortic Valve Replacement With Self-Expanding ACURATE neo2: PostproceduralHemodynamic and Short-Term ClinicalOutcomes.

The first-generation ACURATE neo transcatheter heart valve (THV) (Boston Scientific) was associated with a non-negligible occurrence of moderate or greater paravalvular aortic regurgitation (AR) following transcatheter aortic valve replacement. To overcome this issue, the ACURATE neo2 iteration, which incorporates a taller outer skirt aimed at reducing the occurrence of paravalvular AR, has recently been developed. The aim of this study was to assess the efficacy and safety of the ACURATE neo2 (Boston Scientific) THV in patients with severe aortic valve stenosis. ITAL-neo was an observational, retrospective, multicenter registry enrolling consecutive patients with severe aortic valve stenosis, treated with first- and second-generation ACURATE neo THVs, via transfemoral and trans-subclavian access, in 13 Italian centers. One-to-one propensity score matching was applied to account for baseline characteristics unbalance. The primary endpoint was the occurrence of moderate or greater paravalvular AR on predischarge echocardiographic assessment. Secondary endpoints included postprocedural technical success and 90-day device success and safety. Among 900 patients included in the registry, 220 received the ACURATE neo2 THV, whereas 680 were treated with the first-generation device. A total of 410 patients were compared after 1:1 propensity score matching. The ACURATE neo2 THV was associated with a 3-fold lower frequency of postprocedural moderate or greater paravalvular AR (11.2% vs 3.5%; P< 0.001). No other hemodynamic differences were observed. Postprocedural technical success was similar between the 2 cohorts. Fewer adverse events were observed in patients treated with the ACURATE neo2 at 90days. Transfemoral transcatheter aortic valve replacement using the ACURATE neo2 was associated with a significant lower frequency of moderate or greater paravalvular AR compared with the earlier generation ACURATE neo device, with encouraging short-term safety and efficacy.

Paravalvular Aortic Regurgitation Severity Assessed by Quantitative Aortography: ACURATE neo2 versus ACURATE neo Transcatheter Aortic Valve Implantation.

The new-generation ACURATE neo2 system was commercially released in September 2020. In this study, we sought to compare the aortic regurgitation (AR) severity of the ACURATE neo2 versus the ACURATE neo transcatheter heart valve, using quantitative videodensitometric angiography (qAR). This is a retrospective, Corelab analysis of final post-transcatheter aortic valve implantation (TAVI) aortograms of patients treated with the ACURATE neo2 and ACURATE neo systems. The ACURATE neo2 cohort comprised consecutive patients treated between September 2020 and January 2021 at two centers. The ACURATE neo cohort included consecutive patients treated before September 2020. Our primary objective was to compare AR severity on qAR following TAVI with ACURATE neo2 and ACURATE neo. Out of 401 aortograms, 228 (56.9%) were analyzable, with 120 in the ACURATE neo2 cohort, and 108 in the ACURATE neo cohort. The mean AR fraction was 4.4 ± 4.8% in the neo2 cohort, and 9.9 ± 8.2% in the neo cohort (p < 0.001). Furthermore, moderate or severe AR (qAR > 17%) was detected in 2 aortograms (1.7%) in the neo2 cohort and 15 aortograms (13.9%) in the neo cohort (p < 0.001). Quantitative aortography shows a lower rate of moderate or severe paravalvular AR in what is the first European experience of the new-generation, self-expanding ACURATE neo2 when compared to the first-generation ACURATE neo. Moreover, aortographic data need to be correlated and compared to Core Laboratory-adjudicated 30-day echocardiographic data.

Predictors of paravalvular leak following implantation of the ACURATE neo transcatheter heart valve: the PREDICT PVL study

ObjectivesReport predictors and the natural course of paravalvular leak (PVL) following implantation of the ACURATE neo transcatheter heart valve (THV).BackgroundUnderstanding the mechanisms of PVL may help to improve patient selection,...

Effectiveness and Safety of the ACURATE Neo Prosthesis in 1,000 Patients With Aortic Stenosis

The ACURATE neo transcatheter heart valve has demonstrated a balanced profile with low rates of permanent pacemaker implantation, low risk of coronary obstruction, and favorable hemodynamic properties whilst having an acceptable rate of ≥moderate paravalvular leakage (PVL). Here, we report in-hospital results and assess the learning curve for implantation of the ACURATE neo device in a large, single-center cohort. The cohort of this retrospective, observational study comprised 1,000 consecutive patients with severe aortic stenosis who underwent transfemoral transcatheter aortic valve implantation using the ACURATE neo prosthesis between May 2012 and December 2019. We determined procedural outcomes with emphasis on PVL and analyzed the learning curve. The median age was 81.9 years [IQR 78.8; 85.1], and the Euroscore II was 4.2% [IQR 2.7; 7.3]. The rate of PVL ≥moderate measured by echocardiography at discharge was 3.7% (37 of 988). We observed a learning curve, with a decline in ≥moderate PVL from 6.7% in the first quartile to 0.8% in the last quartile, that was related to better patient selection, more oversizing, and consideration of the amount and distribution of aortic valve calcification. In this thus far largest single-center experience using the ACURATE neo prosthesis, we demonstrate that after completing a learning curve and observation of precepts that include patient selection, careful sizing, and procedural aspects, the rate of ≥moderate PVL may be reduced to <1%.

A bench test study of bioprosthetic valve fracture performed before versus after transcatheter valve-in-valve intervention.

Bioprosthetic valve fracture (BVF) may improve transvalvular gradients and transcatheter heart valve (THV) expansion during VIV interventions. However, the optimal timing of BVF is unknown. We assessed the impact of timing of BVF (before versus after) for valve-in-valve (VIV) intervention, on hydrodynamic function and THV expansion. Three THV designs were assessed, a 23 mm SAPIEN 3 (S3), small ACURATE neo (ACn) and 23 mm Evolut R, deployed into 21 mm Mitroflow bioprosthetic surgical valves. We evaluated each THV in three groups: 1) no BVF, 2) BVF before VIV, and 3) BVF after VIV. Hydrodynamic testing was performed using a pulse duplicator to ISO 5840:2013 standard. Transvalvular gradients were lower when BVF was performed after VIV for the S3 (no BVF 15.5 mmHg, BVF before VIV 8.0 mmHg, BVF after VIV 5.6 mmHg), and the ACn (no BVF 9.8 mmHg, BVF before VIV 8.4 mmHg, BVF after VIV 5.1 mmHg). Transvalvular gradients were similar for the Evolut R, irrespective of performance of BVF or timing of BVF. BVF performed after VIV resulted in better expansion in all three THV designs. The ACn and Evolut R samples all had a mild degree of pinwheeling, and BVF timing did not impact on pinwheeling severity. The S3 samples had severe pinwheeling with no BVF, and significant improvement in pinwheeling when BVF was performed after VIV. BVF performed after VIV was associated with superior THV expansion in all three THV designs tested, with lower residual transvalvular gradients in the S3 and ACn THVs. The Evolut R had similar hydrodynamic performance irrespective of BVF timing. Timing of BVF has potential implications on THV function.

Relevance of New Conduction Disorders After Implantation of the ACURATE Neo Transcatheter Heart Valve in the Aortic Valve Position

The ACURATE neo transcatheter heart valve has been associated with very low rates of new conduction disorders (CDs). We assessed the clinical relevance of new CDs in patients undergoing transcatheter aortic valve replacement (TAVR) with this valve. Data of consecutive patients without a pre-existing left bundle branch block (LBBB) or a permanent pacemaker (PPM) undergoing TAVR with the ACURATE neo were analyzed from the prospective SwissTAVI registry. Patients with new CDs were compared with patients with an unchanged electrocardiogram (ECG). ACURATE neo was implanted in 203 patients (mean age 82 ± 6 years, 63% women), CDs occurred in 28 patients (22 [11%] developed a LBBB, 6 [3%] required a PPM). New CDs resulted in a longer median duration of hospitalization (7 vs 5 days, interquartile range 4 to 13 vs 3 to 8 days, p = 0.04). At 1-year follow-up, left ventricular ejection fraction was significantly lower in patients with new CDs comparedwith patients with an unchanged ECG (54% ± 13% vs 61% ± 9%, p <0.01). Kaplan-Meier estimates of survival at 1-year were 89% in patients with new CDs and 95% in patients with an unchanged ECG (hazard ratio 2.0, 95% confidence interval 0.7 to 6.2, p = 0.22). After TAVR with the self-expanding ACURATE neo valve, the rate of new CDs, including complete LBBB was low and very few patients required a new PPM. However, new CDs prolonged initial hospitalization and increased the risk for left ventricular-dysfunction at 1-year follow-up. Patients without new CDs had excellent outcomes with a very high survival rate at 1-year follow-up.

Valve-in-Valve Implantation Using the ACURATE Neo in Degenerated Aortic Bioprostheses: An International Multicenter Analysis

ObjectivesThis study reports an international experience using the transfemoral ACURATE neo transcatheter heart valve (Boston Scientific, Marlborough, Massachusetts) for the treatment of degenerated surgical aortic bioprostheses. BackgroundTranscatheter valve-in-valve procedures have emerged as an alternative to redo surgery. Supra-annular prostheses might be particularly useful in this indication. MethodsThis is an international multicenter analysis including 85 patients from 14 centers in Europe and Canada undergoing an ACURATE neo valve-in-valve procedure from March 2015 to February 2019. ResultsInternal diameter of the degenerated bioprosthesis was 20.3 ± 2.1 mm. Prosthesis size S was used in 70 (82%) procedures. The median depth of implantation was 3 mm and the upper crown of the ACURATE neo was positioned above the stent posts of the degenerated bioprosthesis in 54 (64%) and inside in 31 (36%). Mean transvalvular gradient before discharge was significantly lower if the upper crown was above the degenerated bioprosthesis (13.7 ± 5.9 mm Hg vs. 19.5 ± 10.0 mm Hg; p = 0.001). However, a high position of the ACURATE neo resulted in embolization in 1 patient, conversion to open-heart surgery in 1, and need for reintervention due to transcatheter heart valve failure within the first 18 months of follow-up in 4. ConclusionsThis early experience shows that a high implantation of the ACURATE neo with the upper crown above the stent posts of the degenerated bioprosthesis resulted in lower mean transvalvular gradients but a higher rate of malpositioning and early valve degeneration.

Impact of implant depth on hydrodynamic function with the ACURATE neo transcatheter heart valve following valve-in-valve transcatheter aortic valve replacement in Mitroflow bioprosthetic valves: an ex vivo bench study.

We aimed to assess the impact of implant depth on hydrodynamic function following valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) using the ACURATE neo transcatheter heart valve (THV) through an ex vivo bench study. Multiple implantation depths were tested at incremental depths of 2 mm using a small size ACURATE neo valve for VIV TAVR in 19 mm, 21 mm, 23 mm, and 25 mm Mitroflow bioprosthetic valves. Multimodality imaging and hydrodynamic evaluation was performed at each implantation depth. A low implantation was associated with higher transvalvular gradients. The highest transvalvular gradient was observed at -10 mm depth for 19 mm (40.0±0.5 mmHg), -8 mm for 21 mm (15.3±0.2 mmHg), -6 mm for 23 mm (14.7±0.3 mmHg) and -8 mm for 25 mm (8.4±0.2 mmHg) surgical valves. The lowest transvalvular gradient was observed at 0 mm depth for the 19 mm (14.9±0.2 mmHg)/21 mm (7.2±0.1 mmHg), and +2 mm depth for the 23 mm (5.7±0.1 mmHg)/25 mm (5.8±0.1 mmHg) surgical valves. At low implantation depth, there was worse leaflet pin-wheeling and also evidence of interaction of THV leaflets with those of the surgical valve that impaired leaflet coaptation, resulting in a high regurgitant fraction (42.5% in the 21 mm and 83.3% in the 23 mm surgical valve at -10 mm depths). A high implant is desirable to facilitate favourable hydrodynamic function when performing VIV TAVR using the ACURATE neo THV for Mitroflow aortic bioprostheses sized ±25 mm. In a 19 mm Mitroflow valve, positioning the upper crown of the ACURATE neo THV above the posts of the surgical valve is desirable to facilitate favourable transvalvular gradients. Low implantation results in higher transvalvular gradients and worse pin-wheeling, and THV leaflet dysfunction can be severe due to interaction with the surgical valve.

The SAVI-TF Registry: 1-Year Outcomes of the European Post-Market Registry Using the ACURATE neo Transcatheter Heart Valve Under Real-World Conditions in 1,000 Patients

ObjectivesThe SAVI-TF (Symetis ACURATE neo Valve Implantation Using Transfemoral Access) registry was initiated to study the ACURATE neo transcatheter heart valve in a large patient population treated under real-world conditions. BackgroundThe self-expanding, supra-annular ACURATE neo prosthesis is a transcatheter heart valve that gained the Conformité Européene mark in 2014, but only limited clinical data are available so far. MethodsThis prospective, multicenter registry enrolled 1,000 patients at 25 European centers who were followed for 1 year post-procedure. ResultsMean patient age was 81.1 ± 5.2 years; mean logistic European System for Cardiac Operative Risk Evaluation I score, European System for Cardiac Operative Risk Evaluation II score, and Society of Thoracic Surgeons score were 18.1 ± 12.5%, 6.6 ± 7.5%, and 6.0 ± 5.6%, respectively. At 1 year, 8.0% (95% confidence interval [CI]: 6.3% to 9.7%) of patients had died, 2.3% (95% CI: 1.3% to 3.2%) had disabling strokes, and 9.9% (95% CI: 8.1% to 11.8%) had permanent pacemaker implantations. Through 1 year, 5 reinterventions (0.5%; 95% CI: 0.1% to 1.0%) were performed: 3 valve-in-valve and 2 surgical aortic valve replacements. Mean effective orifice area was 1.84 ± 0.43 cm2, mean gradient was 7.3 ± 3.7 mm Hg, and greater than mild paravalvular leakage was observed in 3.6% of patients. ConclusionsTransfemoral implantation of the ACURATE neo prosthesis resulted in favorable 1-year clinical and echocardiographic outcomes with very low mortality and new pacemaker rates.

Transfemoral TAVI using the self-expanding ACURATE neo prosthesis: one-year outcomes of the multicentre "CE-approval cohort".

The aim of this study was to assess the safety and performance of the ACURATE neo transcatheter heart valve and its transfemoral delivery system. The prospective, multicentre "CE-approval cohort" consists of a prospective series of the first 89 patients implanted with the ACURATE neo prosthesis. The primary endpoint was all-cause mortality at 30 days. Mean patient age was 83.7±4.4 years and logistic EuroSCORE I was 26.5±7.7%. Procedural success was obtained in 84 patients (94.4%). At 30 days, three patients had died, and two major strokes and one reintervention for a ventricular septal defect occurred, leading to a major adverse cardiac and cerebrovascular event (MACCE) rate of 6.7%. Eight patients (10.3%) received a permanent pacemaker. At one year, 20 patients (22.5%) had died and the MACCE rate was 27%. Effective orifice area was 1.76±0.34 cm2, and mean gradient 7.5±2.8 mmHg. Only three patients (4.5%) had moderate paravalvular regurgitation. NYHA Class III/IV was present in 94.4% of patients at baseline, in 9.9% at 30 days and in 4.5% at one year post procedure. This first-in-human experience with a novel self-expanding heart valve showed low rates of procedural mortality, major stroke and pacemaker implantation, and good performance outcomes.

Transfemoral aortic valve implantation using a self-expanding transcatheter heart valve without pre-dilation

BackgroundThe aim of the present study was to investigate whether transfemoral implantation of the Acurate neo transcatheter heart valve without pre-dilation is feasible. MethodsBetween December 2014 and December 2016, 294 patients were treated with the Acurate neo prosthesis at our center. Of these, 72 cases were performed without pre-dilation. The decision to omit pre-dilation was at the discretion of the operator, preferably in the case of mild to moderate aortic valve calcification (AVC). Propensity matching (1:1) resulted in 48 cases in each group. Main outcomes of interest were device success according to VARC-2 criteria, residual aortic regurgitation (AR) ≥2°, and rate of post-dilation. ResultsMedian [IQR] age in patients without pre-dilation was 82.7years [78.6–85.6], STS score was 4.6% [3.4–6.1], and AVC-score was 1436AU [1043–1682] with mild and moderate AVC in 63.9% and 36.1% of cases, respectively. Device success was achieved in 94.4% of cases, post-dilation was necessary in 26.4%, and one (1.4%) patient had moderate AR. In the matched population, there were no differences regarding device success, rate of AR ≥2°, need for post-dilation, and post-procedural mean gradient, but the group without pre-dilation had shorter procedure (34.0min [27.0–38.8] vs. 43.0min [34.3–52.0]; p<0.001) and fluoroscopy times (7.4min [5.7–9.0] vs. 9.9min [7.9–13.5]; p<0.001). ConclusionIn select patients with mild to moderate AVC, transfemoral implantation of the Acurate neo without pre-dilation is feasible and safe. This allows for a straightforward procedure that may be performed without rapid pacing in the majority of cases.