Outcomes and performance of the ACURATE neo2 transcatheter heart valve in clinical practice: one-yearresults of the ACURATE neo2 PMCF Study.

BACKGROUND: Transcatheter aortic valve implantation is an effective treatment for patients with aortic stenosis; however, complications related to paravalvular leakage (PVL) persist, including increased risk of mortality, cardiovascular mortality, and rehospitalisation. AIMS: We sought to evaluate the clinical outcomes and valve performance at 1 year in patients with severe aortic stenosis treated with the ACURATE neo2 valve in a post-market clinical setting. METHODS: Valve Academic Research Consortium-2 safety events were assessed up to 1 year. Independent core laboratories evaluated echocardiographic measures of valve performance and hypoattenuated leaflet thickening (HALT; as measured by four-dimensional computed tomography). RESULTS: The study enrolled 250 patients (64% female; mean age: 81 years; baseline Society of Thoracic Surgeons risk score: 2.9±2.0%); 246 patients were implanted with ACURATE neo2. All-cause mortality was 0.8% at 30 days and 5.1% at 1 year. The 1-year rates for stroke and disabling stroke were 3.0% and 1.3%, respectively. Overall, HALT of >50% leaflet involvement of at least one leaflet was present in 9% of patients at 30 days and in 12% of patients at 1 year. No association was observed between the presence of HALT and 1-year clinical or haemodynamic outcomes. Early haemodynamic improvements were maintained up to 1 year (mean aortic valve gradient: 47.6±14.5 mmHg at baseline, 7.6±3.2 mmHg at 1 year; mean aortic valve area: 0.7±0.2 cm2 at baseline, 1.7±0.4 cm2 at 1 year). At 1 year, 99% of patients had mild or no/trace PVL (<1% had moderate PVL; no patient had severe PVL). CONCLUSIONS: The study outcomes confirm favourable performance and safety up to 1 year in patients treated with ACURATE neo2 in routine clinical practice. (ClinicalTrials.gov: NCT04655248).

Clinical outcomes of the ACURATE neo2 transcatheter heart valve: a prospective, multicenter, observational, post-market surveillance study.

BACKGROUND: The next-generation ACURATE neo2 transcatheter aortic valve was designed for simplified implantation and to mitigate the risk of paravalvular leak (PVL) compared to the earlier device. AIMS: To collect clinical outcomes and device performance data, including echocardiography and 4-dimensional computed tomography (4D-CT) data, with the ACURATE neo2 transcatheter heart valve in patients with severe aortic stenosis (AS). METHODS: ACURATE neo2 PMCF is a single-arm, multicentre study of patients with severe AS treated in routine clinical practice. The primary safety endpoint was all-cause mortality at 30-days. The primary imaging endpoint was hypo-attenuated leaflet thickening (HALT), measured by core laboratory-adjudicated 4D-CT at 30 days. Secondary endpoints included VARC safety endpoints, procedural success, and evaluation of valve performance via core laboratory-adjudicated echocardiography. RESULTS: The study enrolled 250 patients at 18 European centres (mean age: 80.8 years; 63.6% female; mean STS score: 2.9±2.0%); 246 (98.4%) were successfully treated with ACURATE neo2. The 30-day rates for mortality and disabling stroke were 0.8% and 0%, respectively. The new permanent pacemaker implantation rate was 6.5%. HALT >50% was present in 9.3% of patients at 30 days. Valve haemodynamics improved from baseline to 30 days (mean aortic valve gradient: from 47.6±14.5 mmHg to 8.6±3.9 mmHg; mean aortic valve area: from 0.7±0.2 cm2 to 1.6±0.4 cm2). At 30 days, PVL was evaluated as none/trace in 79.2% of patients, mild in 18.9%, moderate in 1.9%, and severe in 0%. CONCLUSIONS: The study results support the safety and efficacy of TAVI with ACURATE neo2 in patients in routine clinical practice.

Safety and efficacy of minimalist transcatheter aortic valve implantation using a new-generation balloon-expandable transcatheter heart valve in bicuspid and tricuspid aortic valves.

BACKGROUND: Bicuspid aortic valve may be associated with increased complications during transcatheter aortic valve implantation (TAVI). AIMS: Compare balloon-expandable transcatheter heart valve (THV) safety and efficacy in severe tricuspid (TAV) and bicuspid (BAV) aortic stenosis. METHODS: Transfemoral TAVI was performed in 743 patients (Jan 2014-June 2019) using the SAPIEN 3 THV. Aortic valve morphology was determined using computed tomography. Valve Academic Research Consortium-2 (VARC-2) derived safety and efficacy endpoints at 1 year were evaluated. RESULTS: BAV patients (n = 78), were younger (77 [72, 81] vs. 81 [78, 85] years, p < 0.001) with lower surgical risk (EuroSCORE II 2.96% vs. 4.51% p < 0.001). Bicuspid valves were more calcified (BAV 1308mm3, TAV 848mm3 p < 0.001) with more asymmetric calcification (BAV 63/78 (81%), TAV 239/665 (36%), p < 0.001). Device success (BAV 94%, TAV 90%, p = 0.45) and major vascular complications (BAV 6%, TAV 9%, p = 0.66) were comparable. At 1 year, there was a trend toward lower combined all-cause mortality and rehospitalization for congestive heart failure in BAV patients (BAV 7%, TAV 13%, p = 0.08) with significantly lower all-cause mortality in this cohort (BAV 1%, TAV 9%, p = 0.020). VARC-2 time-related valve safety (BAV 22%, TAV 20%, p = 0.60) was comparable; however, bioprosthetic valve thrombosis remained more common in BAV patients (BAV 7%, TAV 2%, p = 0.010, Hazard ratio 3.57 [95% confidence interval 1.26, 10.10]). After propensity score matching, only bioprosthetic valve thrombosis remained significantly different. CONCLUSIONS: Safety and efficacy of the SAPIEN 3 balloon-expandable THV in BAV is comparable with TAV. Higher rates of bioprosthetic valve thrombosis require further investigation.

Evaluation of a Low-Dose Radiation Protocol During Transcatheter Aortic Valve Implantation.

We aimed to evaluate the efficacy and safety of a low-dose imaging protocol to reduce intraprocedural radiation during transcatheter aortic valve implantation (TAVI). Observational analysis: 802 transfemoral TAVI patients receiving balloon-expandable devices ≥23 mm at a high-volume centre. After propensity score matching, a standard-dose group (SD, n = 333) treated between January 2014 and February 2016 was compared with a low-dose group (LD, n = 333) treated between August 2017 and March 2019 after departmental uptake of a low-dose imaging protocol (reduced field size, high table height, use of "fluoro save," 3.75 frames/second acquisition, increased filtering). Primary end point was dose-area product (DAP). Secondary safety end points were VARC-2 device success and a composite of in-hospital complications. The LD protocol was associated with lower DAP (4.64 [2.93, 8.42] vs 22.73 [12.31, 34.58] Gy⋅cm2, p <0.001) and fluoroscopy time (10.4 [8.1, 13.9] vs 11.5 [9.1, 15.3] minutes, p = 0.001). Contrast use was higher in the LD group (LD 110 [94, 130] vs SD 100 [80, 135] milliliters, p = 0.042). Device success (LD 88.3% vs SD 91.3%, p = 0.25), and the composite end point (LD 8.1% vs SD 11.4%, p = 0.19) were similar. In multivariate analysis, the low-dose protocol was associated with a 19.8 Gy⋅cm2 reduction in procedural DAP (p <0.001). In conclusion, compared with standard imaging, a low-dose protocol for TAVI significantly reduced radiation dose without compromising outcomes.

The Clinical Impact of Psoas Muscle Cross-Sectional Area on Medium-Term Mortality After Transcatheter Aortic Valve Implantation.

AIM: Psoas muscle cross-sectional area (CSA) is a proposed marker of frailty associated with mortality after transcatheter aortic valve implantation (TAVI). We assessed the impact of psoas CSA on medium-term mortality over 5 years in a large cohort, adjusted for pre-procedural variables. METHOD: This single-centre registry-derived analysis assessed 1,731 consecutive TAVI patients between 2007 and 31 April 2015 with available abdominal computed tomography scans. Sex-stratified, height-adjusted psoas CSA was measured mid-body of the fourth lumbar vertebra. Kaplan-Meier survival distributions across psoas CSA quartiles were compared. Cox and logistic regression models were used to assess baseline variables associated with the primary outcome, which was mortality within 5 years. RESULTS: Median age was 81 years (interquartile range, 77 - 85); 52.5% were women. The primary endpoint occurred in 555 patients over a mean follow-up of 775 days. Lower psoas CSA quartile patients were older, had a lower body mass index, lower creatinine clearance, and lower rates of previous cardiac surgery, with higher rates of diabetes, coronary artery disease, pacemaker, anaemia, hypoalbuminaemia, and higher European System for Cardiac Operative Risk Evaluation (EuroSCORE). Unadjusted survival by psoas CSA quartile was significantly different in men (log rank p=0.041) but not women (p=0.099). In Bonferroni-adjusted multivariate analysis, psoas CSA quartiles were not significantly associated with mortality. Hypoalbuminaemia (hazard ratio [HR], 2.10; 95% confidence interval [CI], 1.53 - 2.87 [p<0.001]) and increasing age (HR, 1.03 per year; 95% CI, 1.01 - 1.05 [p=0.002]) were associated with increased risk; female sex (HR, 0.63; 95% CI 0.51 - 0.78 [p<0.001]), and hypercholesterolaemia (HR, 0.67; 95%, CI 0.54 0.83 [p<0.001]) with reduced risk. CONCLUSIONS: Psoas CSA was not significantly associated with mortality after adjusting for pre-procedural variables. Hypoalbuminaemia, sex, hypercholesterolaemia, and age were significantly associated with mortality after TAVI.

Influence of marital status in patients undergoing transcatheter aortic valve implantation.

BACKGROUND: Marital status has been described to affect outcome in cardiovascular diseases, however its impact on patients undergoing transcatheter aortic valve implantation (TAVI) is unknown. We therefore aimed to assess the impact of marital status in patients undergoing TAVI. METHODS: Between 2011 and 2015, 779 patients undergoing transfemoral TAVI with known marital status were included in the analysis. The primary endpoint of the study was the composite of cardiac death and readmission for congestive heart failure (CHF) at one year. RESULTS: Mean age was 80.7±5.9 years, 47.8% were female and median logistic EuroScore was 12.7% (8.13-19.39%). Forty-three point three percent of patients were not married. Compared to married patients, unmarried patients were older (82.4±5.5 vs. 79.5±5.8 years; P<0.001), more often female (73.3% vs. 28.3%; P<0.001), presented with a higher logistic EuroScore [13.1% (9.5-21.5%) vs. 11.7% (7.0-18.5%); P<0.001], and more symptomatic with New York Heart Association functional class III/IV (69.7% vs. 60.6%; P=0.009). At one year the incidence of the primary endpoint was higher in unmarried patients (18.7% vs. 12.0%; P=0.011) which was mainly driven by more admissions for CHF (14.1% vs. 7.8%; P=0.007). After multivariable adjustment, marital status was borderline significant regarding CHF (HR 0.61, 95% CI: 0.37-1.02; P=0.06) but not the primary endpoint. CONCLUSIONS: Unmarried patients undergoing TAVI showed a higher incidence of cardiac death or CHF at one year. Hence, marital status should be taken into account in patients with aortic stenosis subjected to TAVI. Whether closer monitoring and intensified medical follow-up improves outcomes remains to be investigated in future studies.

Two birds with one stone: transcatheter valve-in-valve treatment of a failed surgical bioprosthesis with concomitant severe stenosis and paravalvular leak.

Implantation of bioprosthetic surgical valves has been a common procedure in elderly patients with severe aortic stenosis due to patients´ preferences avoiding anticoagulation therapy. However, this valve presents sometime certain deterioration degree (i.e., dysfunction due to stenosis or regurgitation) or even paravalvular leak. Transcatheter heart valve implantation is a good alternative in high-risk patients. The valve-in-valve procedure has been shown to be a safe and effective procedure. However, the presence of the fixed sewing ring of the surgical bioprosthesis can hamper appropriate expansion of the THV. For this reason, the use of cracking balloon seems to be a safe alternative to increase the effective orifice area. We present a case of a patient with a degenerated previous implanted biological valve and paravalvular leak. We used the treatment strategy of valve-in-valve with post-dilatation with high-pressure balloon, in a way to treat both, the degenerated valve and the paravalvular leak. The use of a single percutaneous procedure was enough and safe to treat both problems without further complications.

1-Year Outcomes of the CENTERA-EU Trial Assessing a Novel Self-Expanding Transcatheter Heart Valve.

OBJECTIVES: The purpose of this study is to report the 1-year results of the CENTERA-EU trial. BACKGROUND: The CENTERA transcatheter heart valve (THV) (Edwards Lifesciences, Irvine, California) is a low-profile (14-F eSheath compatible), self-expanding nitinol valve, with a motorized delivery system allowing for repositionability. The 30-day results of the CENTERA-EU trial demonstrated the short-term safety and effectiveness of the valve. METHODS: Implantations were completed in 23 centers in Europe, Australia, and New Zealand. Transfemoral access was used in all patients. Echocardiographic outcomes were adjudicated by a core laboratory at baseline, discharge, 30 days, 6 months, and 1 year. Major adverse clinical events were adjudicated by an independent clinical events committee. RESULTS: Between March 2015 and July 2016, 203 high-risk patients (age 82.7 ± 5.5 years, 67.5% women, 68.0% New York Heart Association functional class III or IV, Society of Thoracic Surgeons score 6.1 ± 4.2%) with severe, symptomatic aortic stenosis underwent transcatheter aortic valve replacement with the CENTERA THV. The primary endpoint of the study was 30-day mortality (1.0%). At 1 year, overall mortality was 9.1%, cardiovascular mortality was 4.6%, disabling stroke was 4.1%, new permanent pacemakers were implanted in 6.5% of patients at risk, and cardiac-related rehospitalization was 6.8%. Hemodynamic parameters were stable at 1 year, with a mean aortic valve gradient of 8.1 ± 4.7 mm Hg, a mean effective orifice area of 1.7 ± 0.42 cm2, and no incidences of severe or moderate aortic regurgitation. CONCLUSIONS: The CENTERA-EU trial demonstrated mid-term safety and effectiveness of the CENTERA THV, with low mortality, sustained improvements in hemodynamic performances, and low incidence of permanent pacemaker implantations in high-risk patients with symptomatic aortic stenosis. (Safety and Performance of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve [CENTERA-2]; NCT02458560).