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Background: Incomplete expansion of balloon-expandable (BE) transcatheter heart valves (THVs) is sometimes treated by ad hoc post-dilatation with an overfilled or larger valvuloplasty balloon. The efficacy of this approach has not been rigorously evaluated, although increased risk for adverse events has been demonstrated. Observational experience suggests that post-dilatation using the original delivery system balloon at the identical filling volume (i.e., double-tap) may routinely improve the degree of THV expansion with low risk.

Aims: We sought to assess the safety and efficacy of a strategy of routine double-tap after BE transcatheter aortic valve implantation (TAVI).

Methods: Patients undergoing TAVI with the SAPIEN 3 Ultra (S3U) valve were prospectively included. Patients with severe annular or subannular calcification were excluded. A validated method of fluoroscopic analysis was utilised to assess the cross-sectional area at the inflow, midpoint, and outflow of the THV before and after double-tap. Thirty-day clinical outcomes were documented.

Results: Routine double-tap was performed in 102 patients. Despite nominal deployment, all patients had some degree of THV underexpansion after the first inflation. Fluoroscopic analysis documented an increase in minimal THV expansion by cross-sectional area of 9.8% for the 20 mm S3U (p=0.151), 9.9% for the 23 mm S3U (p<0.001), 9.2% for the 26 mm S3U (p<0.001), and 8.6% for the 29 mm S3U (p=0.002). There was no stroke or cardiovascular mortality at 30 days.

Conclusions: In favourable anatomy, routine double-tap after BE TAVI improved THV expansion with no safety concerns. The impact of this strategy on THV function, haemodynamic profile, and durability remains to be determined.

Background: Photon-counting detector computed tomography (PCD-CT) offers enhanced spatial resolution and reduced blooming artefacts, potentially improving the evaluation of stented coronary vessels.

Aims: This study aimed to assess the diagnostic performance of dual-source PCD-CT in detecting obstructive in-stent restenosis (ISR).

Methods: We identified consecutive patients with prior coronary stent implantation who underwent clinically indicated coronary computed tomography angiography (CCTA) with PCD-CT and subsequent invasive coronary angiography within 90 days between 2023 and 2024. Obstructive ISR (≥50% diameter stenosis) was determined by visual assessment of CCTA and invasive quantitative coronary angiography (QCA) in a blinded fashion. The diagnostic performance of CCTA for ISR was compared with that of QCA.

Results: A total of 283 stented lesions from 171 patients were included. Of these, only 3 lesions (1.1%) were deemed indeterminate by PCD-CT. Using invasive QCA as the reference standard, PCD-CT demonstrated a lesion-level sensitivity of 80.0%, specificity of 90.4%, positive predictive value (PPV) of 58.2%, negative predictive value (NPV) of 96.4%, and an overall diagnostic accuracy of 88.9% for detecting obstructive ISR. In a subgroup analysis according to the stent diameter (<3.00 mm [n=83] vs ≥3.00 mm [n=108]), there were no significant differences in sensitivity (87.5% vs 86.7%; p=1.00), specificity (93.3% vs 92.5%; p=1.00), PPV (58.3% vs 65.0%; p=1.00), NPV (98.6% vs 97.7%; p=1.00), or overall diagnostic accuracy (92.8% vs 91.7%; p=1.00), respectively.

Conclusions: PCD-CT demonstrated good diagnostic performance for evaluating obstructive ISR using QCA as the reference standard, regardless of stent diameter.

Coronary artery disease (CAD) is the leading cause of heart failure with reduced ejection fraction (HFrEF). Coronary artery bypass grafting (CABG) improves long-term mortality in HFrEF. Percutaneous coronary intervention (PCI) is often performed as an alternative to CABG in patients at high surgical risk. However, in patients with HFrEF and limited myocardial reserve, PCI may result in haemodynamic instability, increasing risk and precluding optimal revascularisation. Mechanical circulatory support (MCS) during high-risk PCI may enhance haemodynamic stability during the procedure and enable complete revascularisation. We thus performed the PROTECT IV trial to determine whether PCI with routine use of the Impella CP microaxial flow pump improves early and late outcomes in patients with HFrEF and complex CAD compared with PCI with or without use of an intra-aortic balloon pump (IABP). PROTECT IV is a prospective, multicentre, randomised, parallel-controlled, open-label, superiority trial with an adaptive design. Patients with complex CAD and left ventricular ejection fraction ≤40% (n=1,252) deemed at excessive surgical risk for bypass grafting by the Heart Team will be randomised in a 1:1 ratio to PCI with Impella CP versus PCI with or without an IABP. The primary endpoint is the composite of all-cause death, stroke, myocardial infarction, unplanned clinically driven revascularisation, durable left ventricular assist device implant or heart transplant, or other hospitalisation for cardiovascular causes at 3-year follow-up, with at least 1-year follow-up in all patients. Prespecified substudies will evaluate the impact of MCS on renal function, the procedural role of right heart catheterisation, and the utility of myocardial viability assessment. The PROTECT IV trial will determine whether routine MCS with Impella CP during high-risk PCI improves the prognosis of patients with complex CAD and HFrEF.

Background: Bleeding remains a frequent complication after transcatheter aortic valve implantation (TAVI). Recently, the Valve Academic Research Consortium High Bleeding Risk (VARC-HBR) criteria were introduced to identify patients at (very) high risk of bleeding.

Aims: This study aimed to evaluate the validity of the VARC-HBR criteria for predicting bleeding risk in TAVI patients and to compare its performance with other existing criteria.

Methods: Data were obtained from the POPular PAUSE TAVI trial, a randomised clinical trial that evaluated the safety and efficacy of continuation versus interruption of oral anticoagulation during TAVI. Major and minor bleeding risk criteria were identified at baseline, and bleeding events were recorded up to 30 days after TAVI. Patients were classified into three groups: those with ≤1 minor criterion (moderate risk), those with 1 major or 2 minor criteria (high risk), and those with ≥2 major or ≥3 minor criteria (very high risk).

Results: A total of 856 patients were included: 332 (39%) were classified at moderate bleeding risk, 337 (39%) at high bleeding risk, and 187 (22%) at very high bleeding risk. Major bleeding occurred in 4.2% of moderate-risk patients, 9.5% in the high-risk group, and 15.0% in the very high-risk group (p<0.001). Receiver operating characteristic analysis showed moderate discriminative performance (area under the curve=0.64, 95% confidence interval: 0.58-0.70). Despite higher-than-expected event rates, the VARC-HBR criteria demonstrated good calibration with observed outcomes.

Conclusions: The VARC-HBR criteria effectively identified distinct subgroups with a stepwise increase in major bleeding post-TAVI. However, their predictive performance for individual risk was moderate.

Background: Intracoronary imaging-guided percutaneous coronary intervention (PCI) has demonstrated clinical benefit over angiography-guided PCI for left main coronary artery (LM) disease. However, the optimal minimal stent area (MSA) thresholds to predict cardiovascular outcomes remain incompletely defined.

Aims: This study aimed to evaluate intravascular ultrasound (IVUS)-measured segmental MSA after LM crossover stenting.

Methods: We identified 829 consecutive patients who underwent IVUS-guided PCI for unprotected LM disease using a single-stent crossover technique. The final MSA was measured at the proximal LM, distal LM, and left anterior descending artery (LAD) ostium. The primary outcome was 5-year major adverse cardiac events (MACE), including all-cause death, myocardial infarction, and target lesion revascularisation.

Results: The MSA cutoff values best predicting 5-year MACE were 11.4 mm² for the proximal LM (area under the curve [AUC] 0.62), 8.4 mm² for the distal LM (AUC 0.58), and 8.1 mm² for the LAD ostium (AUC 0.57). Based on these cutoff values, stent underexpansion in the proximal LM was significantly associated with increased risk of 5-year MACE (adjusted hazard ratio [HR] 2.34; p<0.001). Additionally, patients with simultaneous stent underexpansion in both the distal LM and LAD ostium exhibited a significantly higher risk of 5-year MACE compared with those having adequate expansion or only single-site underexpansion (adjusted HR 2.57; p<0.001).

Conclusions: Achieving sufficient stent expansion in the proximal LM and preventing underexpansion in both the distal LM and LAD ostium are critical for improving long-term clinical outcomes. The identified MSA thresholds may serve as practical benchmarks for stent optimisation during LM PCI.

Editorial note: On 28 May 2025, the manufacturer announced the global discontinuation of sales of its ACURATE neo2 and ACURATE Prime aortic valve systems. The following correspondence, submitted and accepted prior to the market withdrawal, discusses clinical experience with this device. Though no longer relevant for current practice, the Editorial Board believes it is important to document these findings in the interest of transparency and completeness of the scientific record. Accordingly, we are publishing this work as a Research Correspondence, with acknowledgement of the device's discontinued status.