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.
{"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}
Pub Date : 2025-07-30eCollection Date: 2025-07-01DOI: 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}
Pub Date : 2025-07-30eCollection Date: 2025-07-01DOI: 10.4244/AIJ-D-24-00069
Yoshinobu Murasato, Kyohei Meno, Soichiro Omura, Yujiro Ura, Takahiro Mori
Background: 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.
Aims: 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.
Methods: 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.
Results: 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).
Conclusions: RWT is challenging in complex CBLs with calcification, significant tortuosity, and small vessels. BBT offers a viable alternative in these cases.
背景:反向导丝技术(RWT)采用天鹅颈状导丝,用于解决复杂冠状动脉分叉病变(CBLs)中具有挑战性的侧支(SB)布线。然而,它的成功并不能保证。目的:本研究旨在确定与RWT失败相关的因素,并评估远端主血管(MV)球囊阻断技术(BBT)作为替代方案的可行性。方法:回顾性分析32例连续发生的复杂cbl伴SB连线困难的病例。患者被分为两组:RWT成功者(RWT- s, n=17)和在RWT失败或作为主要方法接受BBT的患者(RWT- f /BBT, n=15)。研究了RWT失败的危险因素。结果:SB连接BBT成功率为80%。RTW-F/BBT与较少的左前降支受累量(40% vs 71%)、较小直径的MV支架植入(2.8±0.5 mm vs 3.2±0.5 mm)、更宽的远端MV和中端SB之间的分叉角(BA-β: 51.6±29.8°vs 36.4±18.6°)和更小的远端MV最小管腔直径(MLD)(1.72±0.68 mm vs 2.14±0.58 mm)相关。SB钙化(33% vs 0%;p=0.01), MV远端严重弯曲(53% vs 12%;p=0.02)和SB严重弯曲(73% vs 24%;p=0.01), RTW-F/BBT组更常见。手术前BA-β >34.1°,远端MV MLD。结论:RWT对钙化、明显扭曲和血管小的复杂CBLs具有挑战性。在这些情况下,BBT提供了一个可行的选择。
{"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}
Pub Date : 2025-03-20eCollection Date: 2025-03-01DOI: 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}
Pub Date : 2025-03-20eCollection Date: 2025-03-01DOI: 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
Background: 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.
Aims: 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.
Methods: 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).
Results: 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.
Conclusions: 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.
背景:经导管主动脉瓣植入术(TAVI)是治疗严重主动脉瓣狭窄(AS)的一种微创选择。Crea主动脉瓣(CAV)是一种新型的自膨胀经导管主动脉瓣植入物,已经成功地在临床前研究中进行了测试。目的:我们旨在评估CAV系统的技术成功、设备性能和早期安全性,这是该设备在严重AS患者中的首次人体研究。方法:采用瓣膜学术研究联盟(Valve Academic Research Consortium, VARC)-3标准对3例重度AS高危患者的CAV进行前瞻性评估。进行计算机断层血管造影和经胸超声心动图(TTE)评估,然后按照标准方案进行TAVI。术前、术后、出院前、临床随访1月和6月分别行TTE监测主动脉瓣面积、最大流速(Vmax)、平均压力(MG)和峰值压力梯度、瓣旁漏(PVL)。结果:CAV植入成功,患者1采用尖端重叠技术,患者2和患者3采用共面视图,输送系统可用性好,定位最佳,Vmax降低至。结论:CAV植入成功,系统性能符合VARC-3标准。该装置应在更大的临床研究中进行评估,以获得进一步的有效性和安全性数据。
{"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}
{"title":"Percutaneous device closure of a perimembranous ventricular septal defect in a 2-month-old infant.","authors":"Kalyan Munde, Anant Munde, Mohan Paliwal, Hariom Kolapkar, Anagh T Shetru","doi":"10.4244/AIJ-D-24-00038","DOIUrl":"10.4244/AIJ-D-24-00038","url":null,"abstract":"","PeriodicalId":72310,"journal":{"name":"AsiaIntervention","volume":"11 1","pages":"64-66"},"PeriodicalIF":0.0,"publicationDate":"2025-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11905105/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143671880","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}
Pub Date : 2025-03-20eCollection Date: 2025-03-01DOI: 10.4244/AIJ-D-24-00033
Puneet K Verma, Sanjeev Sroa, Paras Koushal
Background: Despite the significant advancements in interventional cardiology, there is a need for new, metal-free bioresorbable stent systems that preserve the vasomotor function of the treated vessel and decrease the risk of restenosis associated with metal stents and the risk of thrombosis associated with first-generation bioresorbable scaffolds.
Aims: The aim of this study was to assess the safety and efficacy of the MeRes100 bioresorbable scaffold in complex de novo and in-stent restenotic coronary lesions.
Methods: We conducted a retrospective single-centre study that included 86 patients with coronary artery disease who had been implanted with a next-generation MeRes100 sirolimus-eluting bioresorbable vascular scaffold system and followed up to 12 months after the procedure.
Results: The scaffold was successfully delivered to the target lesion with satisfactory stent expansion in 98.84% of cases. Only one patient died, and the in-hospital mortality rate was as low as 1.16% (cardiac death). No cases of major adverse cardiac events, cardiac death, myocardial infarction, ischaemia-driven target lesion revascularisation, or scaffold thrombosis were reported during the follow-up.
Conclusions: Our preliminary data suggest that the thin-strut sirolimus-eluting bioresorbable scaffold appears to be a clinically acceptable, safe, reliable and reproducible strategy to treat both de novo and in-stent restenotic coronary artery lesions. Long-term follow-up of a larger patient population is warranted.
{"title":"A real-world experience with a thin-strut bioresorbable vascular scaffold system: a single-centre study.","authors":"Puneet K Verma, Sanjeev Sroa, Paras Koushal","doi":"10.4244/AIJ-D-24-00033","DOIUrl":"10.4244/AIJ-D-24-00033","url":null,"abstract":"<p><strong>Background: </strong>Despite the significant advancements in interventional cardiology, there is a need for new, metal-free bioresorbable stent systems that preserve the vasomotor function of the treated vessel and decrease the risk of restenosis associated with metal stents and the risk of thrombosis associated with first-generation bioresorbable scaffolds.</p><p><strong>Aims: </strong>The aim of this study was to assess the safety and efficacy of the MeRes100 bioresorbable scaffold in complex <i>de novo</i> and in-stent restenotic coronary lesions.</p><p><strong>Methods: </strong>We conducted a retrospective single-centre study that included 86 patients with coronary artery disease who had been implanted with a next-generation MeRes100 sirolimus-eluting bioresorbable vascular scaffold system and followed up to 12 months after the procedure.</p><p><strong>Results: </strong>The scaffold was successfully delivered to the target lesion with satisfactory stent expansion in 98.84% of cases. Only one patient died, and the in-hospital mortality rate was as low as 1.16% (cardiac death). No cases of major adverse cardiac events, cardiac death, myocardial infarction, ischaemia-driven target lesion revascularisation, or scaffold thrombosis were reported during the follow-up.</p><p><strong>Conclusions: </strong>Our preliminary data suggest that the thin-strut sirolimus-eluting bioresorbable scaffold appears to be a clinically acceptable, safe, reliable and reproducible strategy to treat both <i>de novo</i> and in-stent restenotic coronary artery lesions. Long-term follow-up of a larger patient population is warranted.</p>","PeriodicalId":72310,"journal":{"name":"AsiaIntervention","volume":"11 1","pages":"26-34"},"PeriodicalIF":0.0,"publicationDate":"2025-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11905108/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143671789","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}
Background: Long stents reduce the risk for in-stent restenosis associated with percutaneous coronary interventions in long, tapered coronary lesions.
Aims: The Morph India study investigated the long-term safety and clinical performance of the BioMime Morph sirolimus-eluting stent (SES), a tapered stent used for treating long coronary lesions.
Methods: This is a prospective, multicentre, single-arm, real-world, post-marketing surveillance study conducted among patients with long coronary lesions (length >26 mm to ≤56 mm, reference vessel diameter 2.25-3.50 mm) implanted with the BioMime Morph SES. The primary endpoint was freedom from target lesion failure (TLF). The incidence of target vessel failure (TVF) - defined as a composite of cardiac death related to the target vessel, target vessel myocardial infarction (TVMI), and ischaemia-driven target vessel revascularisation (ID-TVR) - was the secondary endpoint. An angiographic follow-up was conducted at 9 months, and subjects were followed up for 3 years.
Results: Out of 448 enrolled patients, 420 patients completed the 3-year follow-up. The rate of freedom from TLF was 99.31% at 12 months and 98.80% at 3 years. In 3 years, there were 4 events each of TVMI, TVR (including ID-TVR) and ischaemia-driven target lesion revascularisation (all 0.95%). Quantitative coronary angiography analysis at a mean of 9.2 months revealed in-segment late lumen loss (LLL) of 0.29±0.23 mm and in-device LLL of 0.35±0.11 mm. The in-device minimal lumen diameter improved from 0.63±0.42 mm at preprocedure to 2.13±0.37 mm (p<0.001) at 9.2 months.
Conclusions: The 3-year safety and clinical outcomes of BioMime Morph SES for treating long coronary lesions were satisfactory. Further long-term comparative studies are necessary to validate these results.
{"title":"Long-term safety and performance of the BioMime Morph sirolimus-eluting coronary stent system for very long coronary lesions in real-world settings.","authors":"Deepak Davidson, Mukul Misra, Sharad Chandra, Raghu Thagachagere Ramegowda, Bharat Bhushan Chanana, Shuvanan Ray, Keyur Parikh, Sanjeeb Roy, Rajendra Kumar Jain, Sivakumar Rathnavel, Viji Samuel Thomson, Rajalekshmi Subramanian, Pannala Lakshmi Narasimha Kapardhi, Ganesan Manohar, Rajesh Thachathodiyl, Raja Sekhar Varma, Arun Kumar Chopra, Jagdish S Hiremath, Manojkumar Bhavarilal Chopada, Ashokkumar Thakkar","doi":"10.4244/AIJ-D-24-00008","DOIUrl":"10.4244/AIJ-D-24-00008","url":null,"abstract":"<p><strong>Background: </strong>Long stents reduce the risk for in-stent restenosis associated with percutaneous coronary interventions in long, tapered coronary lesions.</p><p><strong>Aims: </strong>The Morph India study investigated the long-term safety and clinical performance of the BioMime Morph sirolimus-eluting stent (SES), a tapered stent used for treating long coronary lesions.</p><p><strong>Methods: </strong>This is a prospective, multicentre, single-arm, real-world, post-marketing surveillance study conducted among patients with long coronary lesions (length >26 mm to ≤56 mm, reference vessel diameter 2.25-3.50 mm) implanted with the BioMime Morph SES. The primary endpoint was freedom from target lesion failure (TLF). The incidence of target vessel failure (TVF) - defined as a composite of cardiac death related to the target vessel, target vessel myocardial infarction (TVMI), and ischaemia-driven target vessel revascularisation (ID-TVR) - was the secondary endpoint. An angiographic follow-up was conducted at 9 months, and subjects were followed up for 3 years.</p><p><strong>Results: </strong>Out of 448 enrolled patients, 420 patients completed the 3-year follow-up. The rate of freedom from TLF was 99.31% at 12 months and 98.80% at 3 years. In 3 years, there were 4 events each of TVMI, TVR (including ID-TVR) and ischaemia-driven target lesion revascularisation (all 0.95%). Quantitative coronary angiography analysis at a mean of 9.2 months revealed in-segment late lumen loss (LLL) of 0.29±0.23 mm and in-device LLL of 0.35±0.11 mm. The in-device minimal lumen diameter improved from 0.63±0.42 mm at preprocedure to 2.13±0.37 mm (p<0.001) at 9.2 months.</p><p><strong>Conclusions: </strong>The 3-year safety and clinical outcomes of BioMime Morph SES for treating long coronary lesions were satisfactory. Further long-term comparative studies are necessary to validate these results.</p>","PeriodicalId":72310,"journal":{"name":"AsiaIntervention","volume":"11 1","pages":"14-25"},"PeriodicalIF":0.0,"publicationDate":"2025-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11905104/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143671875","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}
Pub Date : 2025-03-20eCollection Date: 2025-03-01DOI: 10.4244/AIJ-D-24-00001
Abdul Hakeem, Babar Hasan, Asad Pathan
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