Eurointervention最新文献

Background: There are limited head-to-head randomised trials comparing the performance of different transcatheter heart valves (THVs).

Aims: We aimed to evaluate the non-inferiority of the balloon-expandable Myval THV series compared to the balloon-expandable SAPIEN THV series or the self-expanding Evolut THV series.

Methods: The LANDMARK trial randomised 768 patients in a 1:1 ratio, (Myval THV series [n=384] vs contemporary series with 50% SAPIEN THV series [n=192] and 50% Evolut THV series [n=192]). The non-inferiority of Myval over the SAPIEN or Evolut THV series in terms of the 30-day primary composite safety and effectiveness endpoint as per the third Valve Academic Research Consortium (VARC-3) was tested in an intention-to-treat population with a predefined statistical power of 80% (1-sided alpha of 5%) for a non-inferiority margin of 10.44%.

Results: The Myval THV series achieved non-inferiority for the primary composite endpoint over the SAPIEN THV series (24.7% vs 24.1%, risk difference [95% confidence interval {CI}]: 0.6% [not applicable {NA} to 8.0]; p=0.0033) and the Evolut THV series (24.7% vs 30.0%, risk difference [95% CI]: -5.3% [NA to 2.5]; p<0.0001). The incidences of pacemaker implantation were comparable (Myval THV series: 15.0%, SAPIEN THV series: 17.3%, Evolut THV series: 16.8%). At 30 days, the mean pressure gradient and effective orifice area were significantly better with the Myval THV series compared to the SAPIEN THV series (p<0.0001) and better with the Evolut THV series than with the Myval THV series (p<0.0001). At 30 days, the proportion of moderate to severe prosthetic valve regurgitation was numerically higher with the Evolut THV series compared to the Myval THV series (7.4% vs 3.4%; p=0.06), while not significantly different between the Myval THV series and the SAPIEN THV series (3.4% vs 1.6%; p=0.32).

Conclusions: The Myval THV series is non-inferior to the SAPIEN THV series and the Evolut THV series in terms of the primary composite endpoint at 30 days.

Clinical trial registration: ClinicalTrials.gov: NCT04275726; EudraCT number 2020-000,137-40.

Background: The ACURATE neo2 is a contemporary transcatheter aortic valve implantation (TAVI) system approved for the treatment of severe aortic stenosis in Europe. The ACURATE neo2 has not been evaluated in bicuspid aortic valve (BAV) stenosis.

Aims: We sought to evaluate the safety and efficacy of ACURATE neo2 in patients with BAV stenosis.

Methods: We retrospectively analysed consecutive severe BAV stenosis patients undergoing TAVI with ACURATE neo2 at 10 European centres. Imaging data from preprocedural multislice computed tomography, pre- and postprocedural echocardiography, and procedural cinefluoroscopy were evaluated by a core laboratory. Valve Academic Research Consortium 3 (VARC-3)-defined 30-day procedure safety and efficacy were the primary endpoints. Adverse events were site-reported according to VARC-3 criteria.

Results: Among 181 patients with BAV stenosis treated with the ACURATE neo2, the mean age was 77.5±7.2 years, 58.0% were female, and the Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score was 2.3% (1.6-3.7%). Most procedures were transfemoral, and predilatation was performed in all cases. A second valve was required in 4 cases (2.2%). VARC-3-defined technical success was 95.6%. The primary endpoints of device success and early safety occurred in 90.6% and 82.3%, respectively. At 30 days, cardiovascular death occurred in 2.2% (N=4) and stroke in 1.6% (N=3). Core laboratory-adjudicated echocardiography reported an effective orifice area of 2.0 (1.7-2.5) cm² and a mean transvalvular gradient of 6.5 (4.6-9.0) mmHg. Half of all cases (51.2%) had no paravalvular leak, while moderate leak occurred in 4.3%. A new permanent pacemaker was required in 11 patients (6.5%).

Conclusions: The ACURATE neo2 demonstrated favourable clinical outcomes and bioprosthetic valve performance at 30 days in selected patients with severe BAV stenosis.

Background: New conduction disturbances are frequent after transcatheter aortic valve implantation (TAVI). Refining our ability to predict high-grade atrioventricular block (AVB) occurring later than 24 hours after the procedure would be useful in order to select patients eligible for early discharge.

Aims: This study was designed to identify predictors of high-grade AVB occurring between 24 hours and 30 days after TAVI and to develop and validate a predictive risk score.

Methods: We analysed clinical, procedural, and electrocardiographic parameters of 1,290 TAVI patients. Independent predictors of delayed high-grade AVB were used to develop the predictive score, which was then externally validated in a cohort of 936 patients.

Results: Implantation of self-expanding valves, greater implantation depth, longer PR interval in preprocedural electrocardiogram (ECG) and greater increase of PR duration in next-day ECG, preprocedural right bundle branch block (RBBB) and new-onset left bundle branch block or RBBB that persisted in next-day ECG were independent predictors of delayed high-grade AVB and were combined to develop the Delayed atrioventricular block Prediction for eArly disChargE (D-PACE) score. The areas under the curve of the score were 0.879 (95% confidence interval [CI]: 0.835-0.923) and 0.799 (95% CI: 0.730-0.868) in the derivation and validation cohorts, respectively. Based on the score, patients can be classified into three risk categories; low-risk patients demonstrated an incidence of delayed AVB of less than 1% and are ideal candidates for next-day discharge.

Conclusions: The D-PACE score can be used to stratify TAVI patients according to their risk of delayed high-grade AVB and thereby identify those suitable for next-day discharge.

Background: Redo-transcatheter aortic valve implantation (TAVI) may be unfeasible because of the risk of compromising coronary flow or coronary access by the pinned back leaflets of the index transcatheter aortic valve.

Aims: We aimed to evaluate the feasibility of redo-TAVI using the balloon-expandable SAPIEN 3 (S3) implanted within the self-expanding ACURATE neo2 (ACn2) valve and to identify predictors associated with a high risk of compromising coronary flow.

Methods: A total of 153 post-ACn2 TAVI cardiac computed tomography scans were analysed. Redo-TAVI using an S3 was simulated in two positions: S3 outflow to the ACn2 upper crown (low implant) and S3 outflow to the base of the ACn2 commissural posts (high implant). The risk for coronary flow compromise and inaccessibility was determined by the height of the neoskirt created by the pinned back leaflets and the valve-to-aorta distances.

Results: At a low S3 implant position, risk of coronary flow compromise was predicted in only 8% of patients and this increased to 60% with a high S3 position. In accordance, coronary access was predicted to be unrestricted in 52% versus 13% of patients with a low versus high S3 implantation. Female sex, a small aortic annular dimension and a sinotubular junction-to-aortic annulus mean diameter ratio <1.15 were independent predictors associated with a high risk for coronary flow compromise.

Conclusions: The feasibility of redo-TAVI with an S3 in an ACn2 depends on the implant depth of the S3 and the geometry of the surrounding aorta. A low S3 implant may reduce the risk of coronary flow compromise and inaccessibility.

Background: Little is known about the effects of left ventricular ejection fraction (LVEF) worsening after transcatheter edge-to-edge valve repair (TEER) for mitral regurgitation (MR).

Aims: This study investigated the predictors and clinical impact of LVEF worsening after TEER for primary MR (PMR) and secondary MR (SMR).

Methods: This study included 2,019 patients (493 with PMR and 1,526 with SMR) undergoing successful TEER (postprocedural MR grade ≤2+) in the OCEAN-Mitral registry. The patients were categorised into worsened LVEF (wEF), defined as a relative decrease of >12.9% in LVEF at discharge, and preserved LVEF (pEF). The serial changes in left ventricular (LV) function at 1 year were also evaluated.

Results: Following TEER, 657 (32%) patients demonstrated wEF. The pEF group demonstrated both decreased left ventricular end-diastolic volumes (LVEDV) and end-systolic volumes (LVESV), and the wEF group showed significantly increased LVESV at discharge. Higher LVEF, larger LVEDV, higher B-type natriuretic peptide levels, and moderate/severe aortic regurgitation predicted wEF. Compared with baseline, the wEF group still demonstrated lower LVEF (46% to 43%; p<0.001) but significantly increased stroke volume (48 mL to 53 mL; p=0.001) at 1 year. The incidence of death or heart failure hospitalisation was similar between the wEF and pEF groups (hazard ratio 1.14, 95% confidence interval: 0.72-1.80; p=0.84) and also in patients with PMR and SMR.

Conclusions: LVEF worsening after TEER was not uncommon and was caused by the increased LVESV. LV volumes and some patient-specific factors predicted worsened LVEF which was not associated with long-term clinical outcomes. OCEAN-Mitral registry: UMIN-CTR ID: UMIN000023653.

Background: In patients undergoing transcatheter aortic valve implantation (TAVI), the presence of a low-flow, low-gradient (LFLG) status has been associated with higher mortality at short-term follow-up.

Aims: We aimed to evaluate long-term survival after TAVI in patients with classical (cLFLG) and paradoxical LFLG (pLFLG) aortic stenosis (AS) compared to high-gradient (HG)-AS.

Methods: Patients undergoing TAVI at our centre with a hypothetical minimum 5-year follow-up were divided into 3 groups: (1) HG-AS (mean gradient [MG] >40 mmHg), (2) cLFLG-AS (MG <40 mmHg, ejection fraction [EF] <50%), and (3) pLFLG-AS (MG <40 mmHg, EF ≥50%). The primary endpoint of the study was all-cause mortality. Propensity score-weighted survival analysis was performed to adjust for possible baseline confounders.

Results: A total of 574 subjects were included (73% HG-AS, 15% pLFLG-AS, 11% cLFLG-AS). The median survival time was 4.8 years, with a maximum of 12.3 years. Patients with cLFLG-AS presented the highest baseline cardiovascular risk. At unadjusted survival analysis, patients with cLFLG-AS showed the worst long-term prognosis, with a rapid decrease in survival within the first year, while pLFLG- and HG-AS patients presented similar survival rates (p=0.023). At weighted long-term analysis, cLFLG- and HG-AS had similar survival rates. Baseline EF was not related to long-term mortality, while patients with a post-TAVI left ventricular ejection fraction (LVEF) improvement >10% lived significantly longer (p=0.02).

Conclusions: Classical LFLG-AS patients had lower long-term survival rates as compared to pLFLG-AS and HG-AS patients. However, after adjustment for possible baseline confounders, a low-flow status per se did not have an impact on long-term mortality after TAVI. Post-TAVI LVEF recovery was associated with improved long-term outcome.

Background: The MitraCut procedure employs beating heart transapical (TA) cannulation and endoscopic scissors for dividing the anterior mitral leaflet (AML) to prevent left ventricular outflow tract (LVOT) obstruction in transapical transcatheter mitral valve replacement (TA-TMVR).

Aims: We present the first multicentre experience of the MitraCut procedure prior to TA-TMVR to prevent LVOT obstruction.

Methods: In 6 European centres, the clinical outcomes of all 13 high-risk patients who had undergone the MitraCut procedure during TA-TMVR procedures were retrospectively reviewed regarding technical success, procedural details and outcome.

Results: The MitraCut procedure was successfully completed in 11 patients with 1 cutting attempt, while 2 patients had 2 cutting attempts, with an average procedure duration of 9.0±5.4 min. No patient demonstrated postoperative LVOT obstruction, and all mitral valve (MV) prostheses were competent throughout the follow-up period. However, 1 patient developed a MitraCut-related paravalvular leak (PVL; technical success rate: 12/13). The mean LVOT gradient was 3.9±4.4 mmHg directly after valve expansion and 3.6±3.1 mmHg at follow-up. In-hospital and 30-day mortality were 0%. One patient experiencing MitraCut-related PVL was successfully treated by interventional PVL closure (reintervention rate: n=1). One patient died at 47 days due to cardiac arrhythmia, unrelated to the AML-directed procedure. The mean follow-up at the time of data analysis was 52±34 days.

Conclusions: The MitraCut procedure was effective and reproducible for preventing potential LVOT obstruction in TA-TMVR patients during its initial exploration in 6 European hospitals. Considerations regarding the scissors' characteristics, their handling and cut length are mandatory for safe performance of the procedure.