AsiaIntervention最新文献

Background: The Hydra transcatheter heart valve (THV) utilised in the GENESIS-II study is equipped with an active release mechanism for tentacle deployment, distinguishing it from the Hydra THV used in earlier studies.

Aims: The primary objective of the GENESIS-II study is to assess the ongoing safety and performance of the Hydra THV in treating severe aortic stenosis in patients deemed at high surgical risk.

Methods: This is a prospective, multicentre, non-randomised, investigational study conducted between November 2021 and November 2023. The study enrolled a total of 40 patients exhibiting high surgical risk and symptomatic severe aortic stenosis from 19 sites across India. The primary safety endpoint of the study was cardiovascular mortality at 30 days, while the primary performance endpoint was device success as defined by Valve Academic Research Consortium-2. The 6-month follow-up of the GENESIS-II study is ongoing.

Results: Among the 40 patients, the average age was 74.4±6.7 years, and 65% were male. The rate of device success was 95%. At 30 days, 2.5% of patients experienced cardiovascular mortality, and the incidence of new permanent pacemaker implantation was 7.9%. There was a progressive enhancement in the effective orifice area, transitioning from 0.6±0.2 cm² at baseline to 1.9±0.6 cm² at 30 days (p<0.001). Similarly, the mean aortic valve gradient demonstrated significant improvement from 53.1±12.5 mmHg at baseline to 8.4±4.0 mmHg at 30 days (p<0.001) post-intervention.

Conclusions: The Hydra THV is the first device with an active release mechanism for deploying the supra-annular valve. The observed high rates of device success and procedural safety in the GENESIS-II study may support the continued safety and performance of the device.

Background: Orbital atherectomy (OA) operates via high-speed elliptical crown rotation, enabling focal plaque modification through controlled forward and backward movement.

Aims: This study aimed to identify the anatomical conditions that optimise OA effectiveness on nodular calcium within curved lesions, using in vitro models to allow quantitative assessment of the debulked volume.

Methods: Forty stenotic vessel models containing nodular calcium were created with varying anatomical parameters: two calcium positions (inner vs outer curve), two curvature radii (CR: 10 mm or 20 mm), and two bending angles (BA: 100° or 60°). Each model underwent OA with the Diamondback 360 Coronary OA System, using two 30-second low-speed passes and one 30-second high-speed pass. Microcomputed tomography was performed pre- and post-ablation to measure the calcium volume reduction, maximum depth, and width.

Results: Ablation was significantly greater for nodular calcium on the inner curve compared to that on the outer curve (6.6±0.4 mm³ vs 2.7±0.4 mm³; p<0.0001). Among models with calcium on the inner curve, CR20/BA60 showed the highest volume reduction (8.3±1.4 mm³). For models with calcium on the outer curve, CR20/BA100 resulted in the greatest ablation (5.2±0.9 mm³). Ablation depth, more than width, correlated with the total ablated volume.

Conclusions: Nodular calcium located on the inner curve is more effectively treated with OA. The combination of curvature radius and the bending angle significantly influences procedural efficiency, underscoring the importance of lesion anatomy in OA planning.

Background: The treatment of coronary artery disease (CAD) has evolved significantly over the years with the emergence of drug-coated balloons (DCBs). Research has shown that ethnicity can influence procedural approaches and clinical outcomes. Despite this, there are still limited data on DCB performance in different ethnic groups - particularly Caucasian and East Asian patients.

Aims: In this post hoc analysis of the EASTBOURNE Registry, we aimed to assess differences in clinical outcomes between Caucasian and East Asian patients.

Methods: EASTBOURNE was a prospective, investigator-driven, multicentre, international study investigating the safety and efficacy of a sirolimus-coated balloon (SCB). A propensity-matching analysis was performed to mitigate differences in variables. The primary endpoint was target lesion revascularisation (TLR) at 12 months.

Results: From September 2016 to December 2020, EASTBOURNE enrolled 2,123 patients from 38 centres. This analysis includes 2,084 patients: 1,657 in the Caucasian group and 427 in the East Asian group. After propensity matching, we analysed 602 patients with no significant differences in clinical characteristics. In procedural terms, the Caucasian population had higher baseline percentage diameter stenosis and contrast media usage, but they had lower predilatation rates and used shorter SCBs at higher pressures; the rate of bailout stenting was also higher. Twelve-month follow-up showed higher rates of TLR (6.0% vs 1.5%; p<0.001), whereas major adverse cardiovascular events, all-cause death, and spontaneous myocardial infarction did not differ significantly. Bleeding Academic Research Consortium Type 2-5 bleedings were lower (0.0 vs 5.0%; p<0.001).

Conclusions: In this subgroup analysis of the EASTBOURNE Registry comparing patients of Caucasian versus East Asian origin treated with SCBs, there were higher incidences of TLR but less bleeding in the Caucasian population compared to East Asian patients.

Background: The safety and clinical performance of the Supraflex Cruz sirolimus-eluting stent (SES) have not been explored within a Russian population until now.

Aims: The S-FLEX Russia registry was designed to evaluate the clinical safety and performance of the Supraflex Cruz SES in a real-world, all-comers Russian population undergoing percutaneous coronary intervention (PCI).

Methods: This was a prospective, multicentre, single-arm, observational registry that included 522 patients who underwent PCI with the Supraflex Cruz SES between August 2021 and February 2022, at five hospitals in Russia. Subgroups prespecified for data analysis included patients with diabetes mellitus, bifurcation lesions, type B2/C lesions and at least one long lesion (>20 mm). The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TVMI) and clinically driven target lesion revascularisation (CD-TLR) at 12-month follow-up.

Results: The mean age of the patient population was 64.26±9.46 years. Device and procedural success were 99.4% and 98.9%, respectively. At 12 months, TLF was observed in 16 (3.1%) patients, comprising 8 (1.5%) cardiac deaths, 6 (1.1%) TVMI, and 2 (0.4%) CD-TLR. Only 1 (0.2%) instance of definite stent thrombosis was observed at 12-month follow-up. In the high-risk subgroups, TLF at 12 months was 5.6% in patients with diabetes, 8.5% in bifurcation lesions, 2.8% in complex B2/C lesions, and 1.9% in long lesions (>20 mm).

Conclusions: Low rates of TLF and stent thrombosis at 12-month follow-up demonstrate the excellent safety and clinical performance of the Supraflex Cruz SES in a real-world, all-comers Russian population, including prespecified high-risk subgroups.

Background: Managing coronary artery disease in diabetic patients, especially left main coronary artery (LMCA) disease, requires complex decision-making. Drug-eluting stents, such as the Resolute zotarolimus-eluting stent (ZES), provide a less invasive alternative to coronary artery bypass grafting for revascularisation.

Aims: We aimed to compare the mortality rates between patients with or without diabetes following left main percutaneous coronary intervention (PCI) using the Resolute ZES and to assess the major predictors of cardiac death based on baseline characteristics, lesion features, and procedural details.

Methods: This retrospective cohort study conducted between 2010 and 2019 at a tertiary care cardiac hospital in Bangladesh involved 884 patients undergoing left main PCI with the Resolute ZES. The primary endpoint of this study was the difference in mortality between the two groups (diabetes vs non-diabetes). Descriptive and inferential statistics were used to analyse patient demographics, clinical characteristics, and outcomes. Survival analyses utilised Kaplan-Meier curves and Cox proportional hazards models for both univariate and multivariate analyses.

Results: All-cause mortality (hazard ratio [HR] 0.87, 95% confidence interval [CI]: 0.47-1.61; p=0.67) and cardiac death rates (HR 0.84, 95% CI: 0.43-1.65; p=0.61) were similar for the diabetes and non-diabetes groups, and the predictors of cardiac death in the multivariate analysis included age (HR 1.09, 95% CI: 1.06-1.13; p<0.001), elevated creatinine levels (HR 4.45, 95% CI: 1.80-11.02; p<0.001), and post-dilatation (HR 0.10, 95% CI: 0.03-0.39; p<0.001); the Medina classification also showed a significant association with cardiac death.

Conclusions: The use of the Resolute ZES was associated with comparable outcomes in diabetic and non-diabetic patients undergoing left main PCI. Age, renal function, and certain procedural techniques are key predictors of cardiac death, emphasising the need for individualised patient assessment in LMCA disease management.