Teiger E, Nejjari M, Rosseel L
… +8 more, Kefer J, Verheye S, Lancellotti P, Oliver L, Obadia JF, Asch FM, Blanke P, Dreyfus J
EuroIntervention
· 2025 Nov · PMID 41243777
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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 patient...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).
Yamamoto M, Hioki H, Kagase A
… +22 more, Tsunamoto H, Tokuda T, Sugiura A, Shimura T, Murata A, Yamaguchi R, Shirai S, Ishizu K, Ohno Y, Yashima F, Naganuma T, Watanabe Y, Yamanaka F, Nakazawa G, Noguchi M, Izumo M, Asami M, Nishina H, Fuku Y, Otsuka T, Hayashida K, The Ocean-Tavi Investigators OB
EuroIntervention
· 2025 Nov · PMID 41243775
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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 evalu...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 mm; 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.
Ishizu K, Shirai S, Hayashi M
… +20 more, Morofuji T, Isotani A, Ohno N, Kakumoto S, Ando K, Yamamoto M, Ochiai T, Tsunaki T, Hioki H, Shimura T, Yashima F, Asami M, Yamanaka F, Ohno Y, Nakazawa G, Hachinohe D, Fuku Y, Otsuka T, Hayashida K, Of The Ocean-Tavi Investigators OB
EuroIntervention
· 2025 Nov · PMID 41243774
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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 att...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).
Ohno Y, Kamioka N, Miyamoto J
… +18 more, Omura R, Horinouchi H, Hashimoto K, Noda S, Murakami T, Ikari Y, Okada K, Frazzetto M, Raheja H, Lodi H, Rushing G, Ukaigwe A, Filby S, Yoon S, Feroze R, Palma Dallan LA, Attizzani GF, Tavr Expanded Investigators OBOTC
EuroIntervention
· 2025 Nov · PMID 41243772
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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 o...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.
Tchétché D, Willemen Y, Cesario V
… +1 more, De Backer O
EuroIntervention
· 2025 Nov · PMID 41243771
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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 ab...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.
Deharo JC, Dreyfus J, Bongiorni MG
… +13 more, Burri H, Defaye P, Glikson M, Lever N, Mangieri A, Mondésert B, Nielsen JC, Shah M, Starck CT, Rao A, Leclercq C, Praz F, Reviewers
EuroIntervention
· 2025 Nov · PMID 41243769
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Up to one-third of patients referred for transcatheter tricuspid valve intervention (TTVI) have a transvalvular pacemaker (PPM) or implantable cardioverter-defibrillator (ICD) lead in place. Both the electrophysiology an...Up to one-third of patients referred for transcatheter tricuspid valve intervention (TTVI) have a transvalvular pacemaker (PPM) or implantable cardioverter-defibrillator (ICD) lead in place. Both the electrophysiology and interventional cardiology communities have been alerted to the complexity of decision-making in this situation due to potential interactions between the leads and the TTVI material, including the risk of jailing or damage to the leads. This document, commissioned by the European Heart Rhythm Association and the European Association of Percutaneous Cardiovascular Interventions of the ESC, reviews the scientific evidence to inform Heart Team discussions on the management of patients with a PPM or ICD who are scheduled for or have undergone TTVI. <span class="call_table_figure" style="color:#000000;font-size:15px;font-weight:bold;">Graphical abstract</span>.
Tiong D, Pinilla-Echeverri N, Wood DA
… +17 more, Mehran R, Storey RF, Feldman L, Moreno R, Rao S, Cantor WJ, Welsh R, Bainey KR, Cohen EA, Tsang MB, Sibbald M, Natarajan MK, Wijesena D, Mani T, Nguyen H, Cairns JA, Mehta SR
EuroIntervention
· 2025 Oct · PMID 41117658
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BACKGROUND: The COMPLETE trial demonstrated a reduction in cardiovascular (CV) death or new myocardial infarction (MI) after complete, rather than culprit-only, revascularisation in patients with ST-segment elevation myo...BACKGROUND: The COMPLETE trial demonstrated a reduction in cardiovascular (CV) death or new myocardial infarction (MI) after complete, rather than culprit-only, revascularisation in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease (MVD). However, it is unknown whether this benefit varies according to baseline left ventricular ejection fraction (LVEF). AIMS: We aimed to determine the effects of complete versus culprit-only revascularisation according to LVEF. METHODS: Baseline LVEF was available for 2,214 of 4,041 randomised patients. The effect of both strategies on the first co-primary outcome of CV death or new MI and the second co-primary outcome of CV death, new MI, or ischaemia-driven revascularisation (IDR) was determined within the prespecified LVEF ranges of <45% (N=660) and ≥45% (N=1,554). An analysis of clinical outcomes by LVEF according to thirds was also conducted. RESULTS: Patients with LVEF <45% experienced a significantly higher incidence of the first co-primary outcome compared with those with LVEF ≥45% (4.2%/year vs 2.8%/year; hazard ratio [HR] 1.51, 95% confidence interval [CI]: 1.15-1.98; p=0.003). Compared with a culprit-only strategy, complete revascularisation consistently reduced the first co-primary outcome in patients with LVEF <45% (3.0%/year vs 5.5%/year; HR 0.55, 95% CI: 0.36-0.86) and those with LVEF ≥45% (2.4%/year vs 3.2%/year; HR 0.74, 95% CI: 0.52-1.04; interaction p=0.31). Complete revascularisation also consistently reduced the second co-primary outcome in patients with LVEF <45% (3.5%/year vs 7.3%/year; HR 0.49, 95% CI: 0.33-0.74) and those with LVEF ≥45% (2.7%/year vs 6.3%/year; HR 0.44, 95% CI: 0.33-0.60; interaction p=0.67). Consistent results were observed for both co-primary outcomes when LVEF was further stratified into categories of LVEF ≤35%, 36-49% and ≥50%. CONCLUSIONS: Among patients presenting with STEMI and MVD, those with reduced LVEF are at higher risk of ischaemic events than patients with preserved LVEF. There is a consistent benefit of complete revascularisation regardless of baseline LVEF.
Dumpies O, van Wiechen M, Jobs A
… +12 more, Abdelhafez A, Detto Loria JR, Richter I, Feistritzer HJ, Majunke N, Noack T, Desch S, Thiele H, Dumonteil N, Tchétché D, van Mieghem N, Abdel-Wahab M
EuroIntervention
· 2025 Oct · PMID 41117657
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BACKGROUND: Percutaneous large-bore arteriotomy closure devices are either suture- or plug-based. The comparative efficacy and safety of both techniques and optimal patient selection remain controversial. AIMS: We aimed...BACKGROUND: Percutaneous large-bore arteriotomy closure devices are either suture- or plug-based. The comparative efficacy and safety of both techniques and optimal patient selection remain controversial. AIMS: We aimed to conduct a patient-level meta-analysis of randomised trials comparing suture-based ProGlide versus plug-based MANTA large-bore vascular closure devices (VCDs). METHODS: We searched PubMed, the Cochrane Central Register of Controlled Trials, and Google Scholar for randomised controlled trials comparing vascular closure with the ProGlide-based and the MANTA-based technique. The primary endpoint of this analysis was access site-related vascular complications defined according to the Valve Academic Research Consortium-3 criteria. RESULTS: We identified 2 trials that enrolled a total of 722 patients undergoing transcatheter aortic valve implantation. The primary endpoint was significantly less common after vascular closure with the ProGlide-based technique (odds ratio [OR] 0.54, 95% confidence interval [CI]: 0.35-0.82). Access site-related bleeding events were also less common with the ProGlide-based technique (OR 0.41, 95% CI: 0.18-0.94). Prespecified subgroup analyses did not reveal any subgroup favouring the plug-based technique. Clinical outcomes with the MANTA-based technique were better in larger-sized vessels. Patients who received the ProGlide-based technique were less likely to undergo endovascular stenting or vascular surgery (OR 0.22, 95% CI: 0.06-0.79). CONCLUSIONS: In this patient-level meta-analysis of randomised trials, the ProGlide-based technique for large-bore arterial access was superior to the MANTA-based technique in terms of vascular and bleeding complications.
Xu K, Fu X, Yang W
… +10 more, Wu Y, Li C, Ding D, Wang Z, Chu M, Qian J, He B, Tu S, Shen L, Ge J
EuroIntervention
· 2025 Oct · PMID 41117656
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BACKGROUND: The drug delivery eï¬ciency of drug-coated balloons (DCBs) in de novo coronary artery disease is correlated with atherosclerotic plaque characteristics. It remains to be elucidated whether plaque composition...BACKGROUND: The drug delivery eï¬ciency of drug-coated balloons (DCBs) in de novo coronary artery disease is correlated with atherosclerotic plaque characteristics. It remains to be elucidated whether plaque composition and vulnerability can affect the efficacy of DCBs. AIMS: This study aimed to explore the association between a novel angiography-based radial wall strain (RWS) measurement for plaque vulnerability and DCB efficacy in de novo small vessel disease (SVD). METHODS: This study is a post hoc analysis of 266 SVD lesions in 260 patients treated with a paclitaxelâcoated balloon or plain old balloon angioplasty (POBA) from the PEPCAD China SVD study. The baseline maximum RWS (RWS) ≥13% was selected as the cutoff value for vulnerable plaques. The primary outcome was in-segment late lumen loss (LLL) at 9-month follow-up. RESULTS: A total of 152 and 72 lesions in the DCB and POBA groups, respectively, completed the 9-month angiographic follow-up. In the DCB group, lesions with RWS ≥13% had higher in-segment LLL (0.24±0.53 mm vs 0.05±0.16 mm; p=0.0009), greater binary restenosis (14.9% vs 1.9%; p=0.0040) and more target lesion failure (10.2% vs 1.6%; p=0.022) than those with RWS <13%. Among all the lesions with RWS ≥13%, no significant difference was observed in in-segment LLL (0.24±0.53 mm vs 0.32±0.48 mm; p=0.49) between the DCB and POBA groups. CONCLUSIONS: Angiographically derived RWS has the potential to predict the angiographic and clinical outcomes of DCB treatment for de novo SVD (PEPCAD China SVD study; ClinicalTrials.gov: NCT03625830).
Fezzi S, Scheller B, Rissanen TT
… +8 more, Malivojevic R, Tavella D, Lunardi M, Cortese B, Banning A, Pesarini G, Ribichini F, Scarsini R
EuroIntervention
· 2025 Oct · PMID 41071571
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Coronary bifurcation lesions (CBLs) represent a common and challenging subset of coronary artery disease requiring percutaneous coronary intervention (PCI). While drug-eluting stents (DES) remain the cornerstone of treat...Coronary bifurcation lesions (CBLs) represent a common and challenging subset of coronary artery disease requiring percutaneous coronary intervention (PCI). While drug-eluting stents (DES) remain the cornerstone of treatment, their use is associated with risks such as restenosis, thrombosis, side branch (SB) jailing and the need for prolonged dual antiplatelet therapy. Drug-coated balloons (DCBs) have emerged as a promising alternative, delivering antiproliferative drugs without permanent implants, thereby reducing the risk of late complications and preserving native vessel geometry. This review explores the role of DCBs in CBL management, particularly for SB treatment within the provisional stenting strategy. Evidence from clinical studies indicates that DCBs significantly reduce late lumen loss and restenosis in the SB compared to plain balloon angioplasty, while simplifying PCI procedures and avoiding extensive stenting. Furthermore, hybrid/blended strategies combining DCBs with DES have shown superior clinical and angiographic outcomes in true CBLs compared to DES-only approaches. Despite their potential, the adoption of DCBs faces challenges, including the need for optimal lesion preparation and a lack of standardised procedural techniques. Existing randomised controlled trials are limited by small sample sizes, design heterogeneity, inclusion of bare metal stents either as comparators or as part of the treatment strategy, and inconsistent use of key procedural steps such as proximal optimisation technique and kissing balloon inflation. This manuscript aims to provide interventional cardiologists with practical guidance for managing CBLs, focusing on the effective integration of DCBs into standalone and hybrid strategies. By emphasising procedural optimisation and complication reduction, this review seeks to promote more standardised and reproducible approaches in clinical practice.