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Performance of drug-coated balloons in East Asian and Caucasian patients: a post hoc analysis of the EASTBOURNE Registry. 药物包覆气球在东亚和高加索患者中的表现:伊斯特伯恩注册的事后分析。
AsiaIntervention Pub Date : 2025-07-30 eCollection Date: 2025-07-01 DOI: 10.4244/AIJ-D-24-00044
Antoine El Khoury, Sara Malakouti, Alfonso Ielasi, Jegan Sivalingam, Antonio Greco, Bharat Vashdev Khialani, Dario Gattuso, Bernardo Cortese
{"title":"Performance of drug-coated balloons in East Asian and Caucasian patients: a post hoc analysis of the EASTBOURNE Registry.","authors":"Antoine El Khoury, Sara Malakouti, Alfonso Ielasi, Jegan Sivalingam, Antonio Greco, Bharat Vashdev Khialani, Dario Gattuso, Bernardo Cortese","doi":"10.4244/AIJ-D-24-00044","DOIUrl":"10.4244/AIJ-D-24-00044","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Aims: </strong>In this <i>post hoc</i> analysis of the EASTBOURNE Registry, we aimed to assess differences in clinical outcomes between Caucasian and East Asian patients.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":72310,"journal":{"name":"AsiaIntervention","volume":"11 2","pages":"e129-e138"},"PeriodicalIF":0.0,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12308709/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144755178","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Clinical safety and performance of a biodegradable polymer-coated sirolimus-eluting stent in an all-comers population: results from the S-FLEX Russia registry. 可生物降解聚合物涂层西罗莫司洗脱支架在所有人群中的临床安全性和性能:来自S-FLEX俄罗斯注册的结果
AsiaIntervention Pub Date : 2025-07-30 eCollection Date: 2025-07-01 DOI: 10.4244/AIJ-D-24-00045
Alexey Protopopov, Nikita Litvinyuk, Dmitriy Stolyarov, Danil Rashytov, Oleg Krestyaninov, Aram Badoyan, Victor Maiskov, Denis Samochatov, Denis Shestov, Dmitriy Skrypnik, Andrey Kostin
{"title":"Clinical safety and performance of a biodegradable polymer-coated sirolimus-eluting stent in an all-comers population: results from the S-FLEX Russia registry.","authors":"Alexey Protopopov, Nikita Litvinyuk, Dmitriy Stolyarov, Danil Rashytov, Oleg Krestyaninov, Aram Badoyan, Victor Maiskov, Denis Samochatov, Denis Shestov, Dmitriy Skrypnik, Andrey Kostin","doi":"10.4244/AIJ-D-24-00045","DOIUrl":"10.4244/AIJ-D-24-00045","url":null,"abstract":"<p><strong>Background: </strong>The safety and clinical performance of the Supraflex Cruz sirolimus-eluting stent (SES) have not been explored within a Russian population until now.</p><p><strong>Aims: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":72310,"journal":{"name":"AsiaIntervention","volume":"11 2","pages":"e101-e109"},"PeriodicalIF":0.0,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12285379/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144710018","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Ultrathin-strut stents - towards zero stent-related events? 超薄支架支架-迈向零支架相关事件?
AsiaIntervention Pub Date : 2025-07-30 eCollection Date: 2025-07-01 DOI: 10.4244/AIJ-E-25-00004
Sripal Bangalore
{"title":"Ultrathin-strut stents - towards zero stent-related events?","authors":"Sripal Bangalore","doi":"10.4244/AIJ-E-25-00004","DOIUrl":"10.4244/AIJ-E-25-00004","url":null,"abstract":"","PeriodicalId":72310,"journal":{"name":"AsiaIntervention","volume":"11 2","pages":"e97-e98"},"PeriodicalIF":0.0,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12285411/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144710022","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Assessing mortality rates and predictors of cardiac death in diabetic and non-diabetic patients after left main percutaneous coronary intervention with the Resolute zotarolimus-eluting stent in Bangladesh: a comprehensive analysis. 评估孟加拉国使用Resolute佐他莫司洗脱支架的糖尿病和非糖尿病患者左主干经皮冠状动脉介入治疗后的死亡率和心脏死亡预测因素:一项综合分析。
AsiaIntervention Pub Date : 2025-07-30 eCollection Date: 2025-07-01 DOI: 10.4244/AIJ-D-24-00034
Fazila Tun-Nesa Malik, Mohammad Kalimuddin, Nazir Ahmed, Mohammad Badiuzzaman, Mir Nesaruddin Ahmed, Ashok Dutta, Dhiman Banik, Mohammad Habibur Rahman, Tawfiq Shahriar Huq
{"title":"Assessing mortality rates and predictors of cardiac death in diabetic and non-diabetic patients after left main percutaneous coronary intervention with the Resolute zotarolimus-eluting stent in Bangladesh: a comprehensive analysis.","authors":"Fazila Tun-Nesa Malik, Mohammad Kalimuddin, Nazir Ahmed, Mohammad Badiuzzaman, Mir Nesaruddin Ahmed, Ashok Dutta, Dhiman Banik, Mohammad Habibur Rahman, Tawfiq Shahriar Huq","doi":"10.4244/AIJ-D-24-00034","DOIUrl":"10.4244/AIJ-D-24-00034","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Aims: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":72310,"journal":{"name":"AsiaIntervention","volume":"11 2","pages":"e119-e128"},"PeriodicalIF":0.0,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12285398/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144710017","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Mitral annular calcification in interventional cardiology: address all fears. 介入心脏病学中的二尖瓣环钙化:消除所有恐惧。
AsiaIntervention Pub Date : 2025-07-30 eCollection Date: 2025-07-01 DOI: 10.4244/AIJ-D-24-00039
Kyriakos Dimitriadis, Christina Drikou, Chrysali-Eirini Georgoulea, Nikolaos Pyrpyris, Panagiotis Tsioufis, Panagiotis Iliakis, Eirini Beneki, Christina Chrysohoou, Mony Shuvy, Konstantinos Aznaouridis, Konstantina Aggeli, Konstantinos Tsioufis
{"title":"Mitral annular calcification in interventional cardiology: address all fears.","authors":"Kyriakos Dimitriadis, Christina Drikou, Chrysali-Eirini Georgoulea, Nikolaos Pyrpyris, Panagiotis Tsioufis, Panagiotis Iliakis, Eirini Beneki, Christina Chrysohoou, Mony Shuvy, Konstantinos Aznaouridis, Konstantina Aggeli, Konstantinos Tsioufis","doi":"10.4244/AIJ-D-24-00039","DOIUrl":"10.4244/AIJ-D-24-00039","url":null,"abstract":"<p><p>Mitral annular calcification (MAC) is a particularly challenging pathological condition that can prove difficult to address. It consists of calcium depositions in the mitral valve ring, secondary to chronic inflammation and complex molecular pathogenetic mechanisms of injury and cellular response. MAC has been associated with worse survival in patients with valvulopathies compared to individuals without MAC, as well as with an enhanced risk for cardiovascular events and all-cause mortality. MAC also complicates interventions in the aortic and mitral valves, with several reports showcasing suboptimal results after transcatheter aortic valve implantation (TAVI). For mitral interventions, it is currently being evaluated whether transcatheter edge-to-edge repair (TEER) or transcatheter mitral valve replacement (TVMR) would best suit these patients, in the presence of severe mitral regurgitation (MR), with both procedures showing benefit in early study results. However, the limitations of each procedure for certain phenotypes and anatomies necessitate more extensive research, aiming to identify the most suitable candidates for each intervention. The purpose of this review is, thus, to present a summary of the factors that affect MAC, explore available diagnostic and therapeutic approaches, and provide a framework to anticipate and overcome the potential challenges that may arise during MAC-associated mitral valve disease treatment.</p>","PeriodicalId":72310,"journal":{"name":"AsiaIntervention","volume":"11 2","pages":"e139-e148"},"PeriodicalIF":0.0,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12285396/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144710019","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
What do we need to maximise the effect of drug-coated balloons? An Asian perspective. 我们需要怎样才能使涂有药物的气球发挥最大的作用?亚洲人的视角。
AsiaIntervention Pub Date : 2025-07-30 eCollection Date: 2025-07-01 DOI: 10.4244/AIJ-E-25-00003
Takashi Muramatsu
{"title":"What do we need to maximise the effect of drug-coated balloons? An Asian perspective.","authors":"Takashi Muramatsu","doi":"10.4244/AIJ-E-25-00003","DOIUrl":"10.4244/AIJ-E-25-00003","url":null,"abstract":"","PeriodicalId":72310,"journal":{"name":"AsiaIntervention","volume":"11 2","pages":"e99-e100"},"PeriodicalIF":0.0,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12285389/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144710023","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Predictors of failure in the reverse wire technique for complex coronary bifurcation lesions. 复杂冠状动脉分叉病变反丝技术失败的预测因素。
AsiaIntervention Pub Date : 2025-07-30 eCollection Date: 2025-07-01 DOI: 10.4244/AIJ-D-24-00069
Yoshinobu Murasato, Kyohei Meno, Soichiro Omura, Yujiro Ura, Takahiro Mori
{"title":"Predictors of failure in the reverse wire technique for complex coronary bifurcation lesions.","authors":"Yoshinobu Murasato, Kyohei Meno, Soichiro Omura, Yujiro Ura, Takahiro Mori","doi":"10.4244/AIJ-D-24-00069","DOIUrl":"10.4244/AIJ-D-24-00069","url":null,"abstract":"<p><strong>Background: </strong>The reverse wire technique (RWT), with a guidewire shaped in a swan-neck configuration, is used to address challenging side branch (SB) wiring in complex coronary bifurcation lesions (CBLs). However, its success is not guaranteed.</p><p><strong>Aims: </strong>This study aimed to identify factors associated with RWT failure and to assess the feasibility of the balloon blocking technique (BBT) in the distal main vessel (MV) as an alternative.</p><p><strong>Methods: </strong>Thirty-two consecutive complex CBLs with difficult SB wiring were retrospectively analysed. Patients were divided into two groups: those with successful RWT (RWT-S, n=17) and those who underwent BBT, either after RWT failure or as a primary approach (RWT-F/BBT, n=15). Risk factors for RWT failure were examined.</p><p><strong>Results: </strong>The success rate of SB wiring with BBT was 80%. RTW-F/BBT was associated with less involvement of the left anterior descending artery (40% vs 71%), smaller-diameter MV stent implantation (2.8±0.5 mm vs 3.2±0.5 mm), wider bifurcation angle (BA) between the distal MV and middle SB (BA-β: 51.6±29.8° vs 36.4±18.6°), and smaller minimum lumen diameter (MLD) in the distal MV (1.72±0.68 mm vs 2.14±0.58 mm). SB calcification (33% vs 0%; p=0.01), severe bending in the distal MV (53% vs 12%; p=0.02) and severe bending in the SB (73% vs 24%; p=0.01) were more common in the RTW-F/BBT group. A receiver operating characteristic curve analysis showed that a combination of preprocedural BA-β >34.1°, distal MV MLD <1.77 mm, and SB calcification had good discrimination ability for predicting RWT failure (area under the curve 0.85, 95% confidence interval: 0.71-0.98).</p><p><strong>Conclusions: </strong>RWT is challenging in complex CBLs with calcification, significant tortuosity, and small vessels. BBT offers a viable alternative in these cases.</p>","PeriodicalId":72310,"journal":{"name":"AsiaIntervention","volume":"11 2","pages":"e110-e118"},"PeriodicalIF":0.0,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12285399/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144710020","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Successful bailout using perfusion balloon for iatrogenic catheter-induced coronary artery dissection. 应用灌注球囊成功救助医源性导管诱导的冠状动脉夹层。
AsiaIntervention Pub Date : 2025-07-30 eCollection Date: 2025-07-01 DOI: 10.4244/AIJ-D-24-00070
Ryota Miyamoto, Norihito Kageyama, Yuta Fujimoto, Yuko Maegawa, Hiroyuki Fujinaga
{"title":"Successful bailout using perfusion balloon for iatrogenic catheter-induced coronary artery dissection.","authors":"Ryota Miyamoto, Norihito Kageyama, Yuta Fujimoto, Yuko Maegawa, Hiroyuki Fujinaga","doi":"10.4244/AIJ-D-24-00070","DOIUrl":"10.4244/AIJ-D-24-00070","url":null,"abstract":"","PeriodicalId":72310,"journal":{"name":"AsiaIntervention","volume":"11 2","pages":"e149-e150"},"PeriodicalIF":0.0,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12285388/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144710021","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Overcoming cardiogenic shock and vascular access challenges with LAVA-ECMO. 利用 LAVA-ECMO 克服心源性休克和血管通路难题。
AsiaIntervention Pub Date : 2025-03-20 eCollection Date: 2025-03-01 DOI: 10.4244/AIJ-D-24-00056
Alvin H Y Ko, Michael Chiang, Ivan Wong, Angus Shing Fung Chui, Michael Kang-Yin Lee
{"title":"Overcoming cardiogenic shock and vascular access challenges with LAVA-ECMO.","authors":"Alvin H Y Ko, Michael Chiang, Ivan Wong, Angus Shing Fung Chui, Michael Kang-Yin Lee","doi":"10.4244/AIJ-D-24-00056","DOIUrl":"https://doi.org/10.4244/AIJ-D-24-00056","url":null,"abstract":"","PeriodicalId":72310,"journal":{"name":"AsiaIntervention","volume":"11 1","pages":"44-45"},"PeriodicalIF":0.0,"publicationDate":"2025-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11905091/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143671877","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Initial experience with the Crea Aortic Valve System - a first-in-human study. Crea主动脉瓣系统的初步经验-首次人体研究。
AsiaIntervention Pub Date : 2025-03-20 eCollection Date: 2025-03-01 DOI: 10.4244/AIJ-D-24-00023
Carlos Calderas, Maurizio Taramasso, Jimmy Levy, Jose Rojas, Luane Piamo, Herman Rodriguez, George De Santolo, Marianela Reinaga, Flavio Ribichini, Kanchan V Bilgi
{"title":"Initial experience with the Crea Aortic Valve System - a first-in-human study.","authors":"Carlos Calderas, Maurizio Taramasso, Jimmy Levy, Jose Rojas, Luane Piamo, Herman Rodriguez, George De Santolo, Marianela Reinaga, Flavio Ribichini, Kanchan V Bilgi","doi":"10.4244/AIJ-D-24-00023","DOIUrl":"10.4244/AIJ-D-24-00023","url":null,"abstract":"<p><strong>Background: </strong>Transcatheter aortic valve implantation (TAVI) is a minimally invasive option for severe aortic stenosis (AS). The Crea Aortic Valve (CAV) is a new self-expanding transcatheter aortic valve implant that has been successfully tested in preclinical studies.</p><p><strong>Aims: </strong>We aimed to assess the technical success, device performance, and early safety of the CAV System in a first-in-human study for the device in patients with severe AS.</p><p><strong>Methods: </strong>We prospectively evaluated the CAV using the Valve Academic Research Consortium (VARC)-3 criteria in three high-risk patients with severe AS. A computed tomography angiography and transthoracic echocardiographic (TTE) assessment were carried out, which was followed by TAVI according to standard protocol. TTE was performed before and after the procedure, before discharge, and at the 1- and 6-month clinical follow-ups to monitor the aortic valve area, the maximum velocity (Vmax), the mean (MG) and peak pressure gradients, and paravalvular leak (PVL).</p><p><strong>Results: </strong>The CAV was successfully implanted, using the cusp-overlap technique for patient 1 and the coplanar view for patients 2 and 3, with good usability of the delivery system for optimal positioning, reduction of the Vmax to <2 m/s and MG to <10 mmHg, and trivial PVL. An atrioventricular block necessitating a permanent pacemaker occurred in one patient. There was no incidence of stroke, heart failure, or renal failure at 6 months of follow-up.</p><p><strong>Conclusions: </strong>The CAV was implanted with success, and the system performed as intended as per VARC-3 criteria. The device should be evaluated in a larger clinical study for further efficacy and safety data.</p>","PeriodicalId":72310,"journal":{"name":"AsiaIntervention","volume":"11 1","pages":"52-59"},"PeriodicalIF":0.0,"publicationDate":"2025-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11905096/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143671874","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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