Eurointervention最新文献

Background: The latest-generation SAPIEN 3 Ultra RESILIA (S3UR) transcatheter heart valve (THV) incorporates several changes in leaflet design, including an improved anticalcification coating and modified commissural attachment. There are no established data on hypoattenuating leaflet thickening (HALT) following transcatheter aortic valve implantation (TAVI) using the S3UR.

Aims: Our study aimed to elucidate the clinical features of HALT following S3UR implantation.

Methods: As a subset of the OCEAN (Optimized CathEter vAlvular INtervention)-TAVI registry, we prospectively assessed patients who underwent cardiac computed tomography (CT) 30 days after S3UR implantation. HALT and potentially relevant THV geometry were analysed using four-dimensional CT data by an independent core laboratory.

Results: Of the 445 patients studied, HALT was detected in 95 patients (21.3%) 30 days after TAVI. The modification of the commissural attachment specific to the 20 mm and 23 mm S3UR THVs did not affect the incidence of HALT (22.1% for ≤23 mm; 20.2% for ≥26 mm; p=0.636). The hourglass-shaped THV frame (p<0.001) and asymmetricity of THV leaflets (p=0.002) were independently associated with HALT development. A trend toward higher mean aortic gradients at 30 days with greater degrees of HALT (HALT >25% vs HALT ≤25%: 10.3 [interquartile range [IQR] 7.0-13.0] mmHg vs 8.6 [IQR 6.3-11.6] mmHg; p=0.007; HALT >50% vs HALT ≤50%: 11.5 [IQR 7.0-14.3] mmHg vs 8.9 [IQR 6.3-11.9] mmHg; p=0.002) was noted.

Conclusions: The incidence of HALT for the S3UR was comparable with the already reported incidences for the previous-generation SAPIEN 3 THV. Given the haemodynamic impact of HALT severity and multiplicity, strategic planning to avoid deformation of the implanted THV might be required. (Clinical trial registration: UMIN000020423).

Background: Given the poor prognosis of tricuspid regurgitation (TR) patients, there is growing interest in addressing TR, particularly since the emergence of novel transcatheter tricuspid valve interventions for patients at high risk for surgery.

Aims: The TRICURE first-in-human (FIH) study evaluates the initial feasibility and clinical safety of the Topaz transcatheter tricuspid valve replacement (TTVR) system in treating TR. Featuring a novel dual-stent design, the system is specifically engineered for the unique anatomy of the tricuspid valve. It has a flexible outer stent with low radial force designed to accommodate annular dynamics and conform to the non-circular, variable shapes of the tricuspid valve, coupled to a rigid inner stent aiming to maintain valve function integrity.

Methods: TRICURE FIH is a prospective, multicentre, first-in-human study with follow-up extending to 5 years. The primary safety endpoint is a composite measure including all-cause mortality, heart failure rehospitalisation, and reintervention for failed tricuspid therapy at 30 days. The primary performance endpoint is device success, defined as a TR reduction ≥1 grade with no more than moderate TR post-procedure.

Results: A total of 20 patients were enrolled. The procedure time (from delivery system insertion to removal) was 35±16 minutes. At 30 days, the primary safety endpoint, a composite of major adverse events, was observed in 35%, and the primary performance endpoint was successfully achieved in all patients (100%), with all patients having a TR reduction of at least 3 grades, and none of the patients having more than mild TR post-procedure. No device-related pacemaker implant was reported. An exemplary case report demonstrates complete elimination of TR and a reverse remodelling of the right ventricle of 19% at 6 months.

Conclusions: The TRICURE FIH study provides evidence of the feasibility and safety of a novel TTVR system. Outcomes need to be confirmed in a larger series. (ClinicalTrials.gov: NCT05126030).

Transcatheter aortic valve implantation (TAVI) has become an established treatment option for symptomatic patients suffering from aortic stenosis. A bicuspid aortic valve (BAV) is the most frequent congenital valvular abnormality. With the expansion of the indications for TAVI to patients at lower risk, including younger populations, a BAV is expected to be more frequently encountered. Several challenges are associated with BAVs, from diagnosis and classification to interventional or surgical treatment. Transcatheter prostheses, designed to treat tricuspid aortic valves, have shown promising results in BAV anatomies. However, technical limitations, such as underexpansion, ellipticity or procedural complications, have been identified. Several issues for transcatheter procedures are still a matter of discussion. In this state-of-the-art review, we explore the knowledge acquired about TAVI for BAVs, the sizing and technical specificities of interventional procedures, as well as the remaining evidence gaps and future perspectives.

Background: Evidence regarding the long-term outcomes and durability of balloon-expandable transcatheter heart valves (BE-THVs) after transcatheter aortic valve implantation (TAVI) is still scarce.

Aims: This study evaluates these outcomes and further examines their association with the annular size in patients.

Methods: A total of 2,699 patients who had undergone TAVI with a BE-THV at least 5 years prior to our study were analysed. A small aortic annulus (SAA) was defined as an area ≤430 mm²; any larger annuli were labelled large aortic annuli (LAA). The primary endpoints were the incidence of all-cause mortality and bioprosthetic valve failure (BVF) between the SAA and LAA groups. As a subanalysis, the primary endpoints were examined in relation to postprocedural mean pressure gradient (mPG) ≥20 mmHg, severe prosthesis-patient mismatch (PPM), and sex differences, comparing SAA and LAA each time.

Results: Overall, 66.4% (n=1,793) of patients were categorised into the SAA group. At 7 years after TAVI, the cumulative all-cause mortality showed differences between the SAA and LAA groups (55.2% vs 58.6%), while BVF assessed by Gray's test was similar between the groups (3.3% vs 2.7%). The Cox multivariable analysis revealed no association between SAA and worse prognosis (hazard ratio 1.07, 95% confidence interval: 0.85-1.36; p=0.56). There were no significant differences in mortality or BVF regarding an mPG ≥20 mmHg, severe PPM, or sex between the SAA and LAA groups (allp>0.05).

Conclusions: Annular size differences were not found to influence long-term outcomes or valve durability following TAVI with a BE-THV, suggesting that other factors warrant further investigation.

Background: The new-generation supra-annular, self-expanding Evolut FX system has the potential to facilitate commissural alignment.

Aims: We sought to assess the feasibility of coronary cannulation (CC) and the impact of commissural and coronary alignment on CC execution, as confirmed by post-transcatheter aortic valve implantation (TAVI) computed tomography (CT).

Methods: The CANNULATE TAVR EXPANDED study is a multicentre, prospective study which included consecutive patients who underwent transfemoral TAVI with the Evolut FX, CC, and angiography after valve deployment. Post-TAVI CT was performed to assess commissural and coronary alignment. Moderate-to-severe commissural and coronary misalignments based on the ALIGN-TAVR Consortium definition were categorised as the misalignment group. The primary endpoint was the rate of successful CC after Evolut FX implantation.

Results: A total of 126 patients were included. CC was successful in 100% of cases for the left coronary artery (LCA) and 96.7% for the right coronary artery (RCA). Moderate-to-severe commissural misalignment was observed in 13.5%, and moderate-to-severe coronary misalignment was observed in 20.6% (LCA) and 22.2% (RCA). Misaligned LCA and RCA required significantly longer CC times. In multivariable analysis, factors associated with suboptimal LCA cannulation were coronary height (odds ratio [OR] 0.73, 95% confidence interval [CI]: 0.57-0.90; p=0.006) and coronary misalignment (OR 4.58, 95% CI: 1.45-14.47; p=0.009), whereas right coronary cusp width (OR 0.63, 95% CI: 0.44-0.90; p=0.007) and coronary misalignment (OR 4.64, 95% CI: 1.29-16.74; p=0.019) were identified for the RCA.

Conclusions: High rates of CC, and commissural and coronary alignment post-TAVI with the Evolut FX were observed in this prospective, multicentre study. Coronary misalignment was identified as the strongest predictor of suboptimal CC for both the LCA and the RCA.