Pub Date : 2025-12-01Epub Date: 2025-10-28DOI: 10.1161/CIRCINTERVENTIONS.125.015577
Antonin Trimaille, Pedro Cepas-Guillén, Juan Hernando Del Portillo, Carlos Giuliani, Jean-Michel Paradis, Eric Dumont, Anthony Poulin, Dimitri Kalavrouziotis, Frederic Beaupré, Jean Porterie, Siamak Mohammadi, Josep Rodés-Cabau
Background: While balloon postdilation (BPD) during transcatheter aortic valve replacement may enhance hemodynamic performance by optimizing valve expansion, it was also linked with leaflet mechanical stress, potentially reducing valve durability. The aim of this study was to investigate the impact of BPD on long-term bioprosthetic valve durability.
Methods: We analyzed the data of a prospective single-center registry including consecutive patients undergoing transcatheter aortic valve replacement between May 2007 and March 2024 alive at 1-year and without a valve-in-valve procedure. To reduce imbalance in baseline and procedural characteristics, the effect of BPD on events was assessed using a propensity score-matched population (215 patients with BPD versus 761 patients without BPD, out of a total of 1911 patients). The primary end point was the occurrence of stage 2 or 3 hemodynamic valve deterioration according to Valve Academic Research Consortium-3.
Results: In the propensity-score matched population, BPD was associated with a lower risk of stage 2 or 3 hemodynamic valve deterioration occurrence compared with no-BPD (2.8% versus 5.8%; subdistribution hazard ratio, 0.37 [95% CI, 0.15-0.95]; P=0.039), and a lower rate of bioprosthetic valve failure (2.8% versus 5.1%; subdistribution hazard ratio, 0.39 [95% CI, 0.15-0.98]; P=0.046). Long-term echocardiographic follow-up up to 10 years showed better hemodynamic parameters over time in patients with BPD. A trend toward a higher prevalence of heart failure hospitalization was observed in patients with BPD.
Conclusions: BPD was associated with a lower incidence of stage 2 and 3 hemodynamic valve deterioration and bioprosthetic valve failure, along with improved bioprosthetic valve hemodynamic parameters over time. Further studies are warranted.
{"title":"Impact of Balloon Postdilation on Long-Term Bioprosthesis Durability After TAVR.","authors":"Antonin Trimaille, Pedro Cepas-Guillén, Juan Hernando Del Portillo, Carlos Giuliani, Jean-Michel Paradis, Eric Dumont, Anthony Poulin, Dimitri Kalavrouziotis, Frederic Beaupré, Jean Porterie, Siamak Mohammadi, Josep Rodés-Cabau","doi":"10.1161/CIRCINTERVENTIONS.125.015577","DOIUrl":"10.1161/CIRCINTERVENTIONS.125.015577","url":null,"abstract":"<p><strong>Background: </strong>While balloon postdilation (BPD) during transcatheter aortic valve replacement may enhance hemodynamic performance by optimizing valve expansion, it was also linked with leaflet mechanical stress, potentially reducing valve durability. The aim of this study was to investigate the impact of BPD on long-term bioprosthetic valve durability.</p><p><strong>Methods: </strong>We analyzed the data of a prospective single-center registry including consecutive patients undergoing transcatheter aortic valve replacement between May 2007 and March 2024 alive at 1-year and without a valve-in-valve procedure. To reduce imbalance in baseline and procedural characteristics, the effect of BPD on events was assessed using a propensity score-matched population (215 patients with BPD versus 761 patients without BPD, out of a total of 1911 patients). The primary end point was the occurrence of stage 2 or 3 hemodynamic valve deterioration according to Valve Academic Research Consortium-3.</p><p><strong>Results: </strong>In the propensity-score matched population, BPD was associated with a lower risk of stage 2 or 3 hemodynamic valve deterioration occurrence compared with no-BPD (2.8% versus 5.8%; subdistribution hazard ratio, 0.37 [95% CI, 0.15-0.95]; <i>P</i>=0.039), and a lower rate of bioprosthetic valve failure (2.8% versus 5.1%; subdistribution hazard ratio, 0.39 [95% CI, 0.15-0.98]; <i>P</i>=0.046). Long-term echocardiographic follow-up up to 10 years showed better hemodynamic parameters over time in patients with BPD. A trend toward a higher prevalence of heart failure hospitalization was observed in patients with BPD.</p><p><strong>Conclusions: </strong>BPD was associated with a lower incidence of stage 2 and 3 hemodynamic valve deterioration and bioprosthetic valve failure, along with improved bioprosthetic valve hemodynamic parameters over time. Further studies are warranted.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e015577"},"PeriodicalIF":7.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145387573","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-10-24DOI: 10.1161/CIRCINTERVENTIONS.125.015430
Rishi Puri, Holger Thiele, Stephan Fichtlscherer, Dirk Westermann, Raj Makkar, Ron Waksman, Samer Hakmi, Lars Sondergaard, Mark Groh, Joseph K Montarello, Joerg Kempfert, Gerald Yong, Francesco Bedogni, Francesco Maisano, Stephen G Worthley, Josep Rodes-Cabau, Gregory P Fontana, Helge Möllmann
Background: There is a paucity of data regarding the longer-term durability of transcatheter heart valves. This analysis aimed to describe the 5-year clinical outcomes and valve durability for patients treated with the Portico transcatheter heart valves across 3 studies harmonized in their prospective enrollment, inclusion/exclusion criteria, centralized independent core laboratory echocardiographic analysis, and independent clinical events committee adjudication.
Methods: Patient-level data from the PORTICO IDE randomized controlled trial, the PORTICO I postmarket study, and the PORTICO continued access protocol were pooled using a random-effects meta-analysis model. All 3 studies collected follow-up data at discharge, 30 days, and annually through 5 years. Adverse events and pooled echocardiographic data were assessed using Valve Academic Research Consortium-2 definitions. Durability definitions were adapted from Valve Academic Research Consortium-3 and European Association of Percutaneous Cardiovascular Interventions/European Society of Cardiology/European Association for Cardio-Thoracic Surgery consensus guidelines.
Results: A total of 1464 patients with severe symptomatic aortic stenosis and high or extreme surgical risk were included. Median age was 83 years, 61.7% were women, and the median Society of Thoracic Surgeons score was 4.9%. At 5 years, all-cause mortality and stroke rates were 49.4% and 12.3%, respectively. Transvalvular gradient and effective orifice area at 5 years were 6.2 mm Hg and 1.83 cm2, respectively, with paravalvular leak ≥moderate severity occurring in 1.9%. The 5-year bioprosthetic valve failure rate was 2.7%, including a 0.7% valve-related death rate and a 2.0% valve reintervention rate, but no patients with severe hemodynamic structural valve deterioration. Moderate hemodynamic structural valve deterioration occurred in 0.9% of the patients at 5 years. Hemodynamic performance and transcatheter heart valve durability remained stable irrespective of annular size.
Conclusions: The use of the Portico transcatheter heart valve system in patients at high or extreme surgical risk demonstrated favorable clinical outcomes and hemodynamic performance with low transvalvular gradients and greater than mild paravalvular leak. Furthermore, bioprosthetic valve failure rates were low with no incidence of severe hemodynamic structural valve deterioration at 5 years, irrespective of annular size.
Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02000115 and NCT01802788.
背景:关于经导管心脏瓣膜的长期耐用性的数据缺乏。本分析旨在描述3项研究中使用Portico经导管心脏瓣膜治疗患者的5年临床结果和瓣膜耐久性,这些研究在前瞻性入组、纳入/排除标准、集中独立核心实验室超声心动图分析和独立临床事件委员会裁决方面进行了协调。方法:采用随机效应荟萃分析模型,将来自PORTICO IDE随机对照试验、PORTICO I上市后研究和PORTICO持续准入协议的患者水平数据汇总。所有3项研究都收集了出院时、30天和每年随访5年的数据。不良事件和汇总超声心动图数据采用瓣膜学术研究协会-2定义进行评估。持久性定义改编自瓣膜学术研究联盟-3和欧洲经皮心血管干预协会/欧洲心脏病学会/欧洲心胸外科协会共识指南。结果:共纳入1464例有严重症状性主动脉瓣狭窄且手术风险高或极高的患者。中位年龄为83岁,61.7%为女性,胸外科学会评分中位数为4.9%。5年时,全因死亡率和中风率分别为49.4%和12.3%。5年经瓣梯度和有效孔口面积分别为6.2 mm Hg和1.83 cm2, 1.9%发生瓣旁渗漏≥中度。5年生物人工瓣膜失败率为2.7%,包括0.7%的瓣膜相关死亡率和2.0%的瓣膜再介入率,但没有患者出现严重的瓣膜血流动力学结构恶化。5年时,0.9%的患者出现中度血流动力学结构性瓣膜恶化。血流动力学性能和经导管心脏瓣膜耐久性保持稳定,与环大小无关。结论:在高或极端手术风险患者中使用Portico经导管心脏瓣膜系统具有良好的临床效果和血流动力学性能,经瓣梯度低,瓣旁泄漏大于轻度。此外,无论瓣膜环大小如何,生物假体瓣膜失败率很低,5年内没有发生严重的瓣膜血流动力学结构恶化。注册:网址:https://www.clinicaltrials.gov;唯一标识符:NCT02000115和NCT01802788。
{"title":"Five-Year Clinical Outcomes and Durability of a Self-Expanding Transcatheter Heart Valve With Intra-Annular Leaflets.","authors":"Rishi Puri, Holger Thiele, Stephan Fichtlscherer, Dirk Westermann, Raj Makkar, Ron Waksman, Samer Hakmi, Lars Sondergaard, Mark Groh, Joseph K Montarello, Joerg Kempfert, Gerald Yong, Francesco Bedogni, Francesco Maisano, Stephen G Worthley, Josep Rodes-Cabau, Gregory P Fontana, Helge Möllmann","doi":"10.1161/CIRCINTERVENTIONS.125.015430","DOIUrl":"10.1161/CIRCINTERVENTIONS.125.015430","url":null,"abstract":"<p><strong>Background: </strong>There is a paucity of data regarding the longer-term durability of transcatheter heart valves. This analysis aimed to describe the 5-year clinical outcomes and valve durability for patients treated with the Portico transcatheter heart valves across 3 studies harmonized in their prospective enrollment, inclusion/exclusion criteria, centralized independent core laboratory echocardiographic analysis, and independent clinical events committee adjudication.</p><p><strong>Methods: </strong>Patient-level data from the PORTICO IDE randomized controlled trial, the PORTICO I postmarket study, and the PORTICO continued access protocol were pooled using a random-effects meta-analysis model. All 3 studies collected follow-up data at discharge, 30 days, and annually through 5 years. Adverse events and pooled echocardiographic data were assessed using Valve Academic Research Consortium-2 definitions. Durability definitions were adapted from Valve Academic Research Consortium-3 and European Association of Percutaneous Cardiovascular Interventions/European Society of Cardiology/European Association for Cardio-Thoracic Surgery consensus guidelines.</p><p><strong>Results: </strong>A total of 1464 patients with severe symptomatic aortic stenosis and high or extreme surgical risk were included. Median age was 83 years, 61.7% were women, and the median Society of Thoracic Surgeons score was 4.9%. At 5 years, all-cause mortality and stroke rates were 49.4% and 12.3%, respectively. Transvalvular gradient and effective orifice area at 5 years were 6.2 mm Hg and 1.83 cm<sup>2</sup>, respectively, with paravalvular leak ≥moderate severity occurring in 1.9%. The 5-year bioprosthetic valve failure rate was 2.7%, including a 0.7% valve-related death rate and a 2.0% valve reintervention rate, but no patients with severe hemodynamic structural valve deterioration. Moderate hemodynamic structural valve deterioration occurred in 0.9% of the patients at 5 years. Hemodynamic performance and transcatheter heart valve durability remained stable irrespective of annular size.</p><p><strong>Conclusions: </strong>The use of the Portico transcatheter heart valve system in patients at high or extreme surgical risk demonstrated favorable clinical outcomes and hemodynamic performance with low transvalvular gradients and greater than mild paravalvular leak. Furthermore, bioprosthetic valve failure rates were low with no incidence of severe hemodynamic structural valve deterioration at 5 years, irrespective of annular size.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT02000115 and NCT01802788.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e015430"},"PeriodicalIF":7.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145353928","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-10-27DOI: 10.1161/CIRCINTERVENTIONS.125.015667
Alexander C Egbe, Allison K Cabalka, Nathaniel W Taggart, Donald J Hagler, Mackram F Eleid, Charanjit S Rihal, Jason H Anderson
Background: The current study aims to describe outcomes after transcatheter valve replacement in adults with congenital heart disease.
Methods: Retrospective study of adults with congenital heart disease who underwent transcatheter valve replacement and had a 1-year follow-up postintervention at Mayo Clinic (2010-2024). The study period was divided into early (2010-2014), mid (2015-2019), and late (2020-2024) eras. The primary outcome was valve reintervention. The secondary outcomes were all-cause mortality and temporal change in prosthetic valve gradient and clinical indices of disease severity.
Results: Overall, 341 patients (age 38±17 years; 175 [51%] men) received 346 prostheses (pulmonary [N=236, 68%], tricuspid [N=75, 22%], aortic [N=22, 8%], and mitral [N=7, 2%]). The prostheses were Sapien (N=181, 52%), Melody (N=142, 41%), and Harmony prostheses (N=23, 7%). The number of transcatheter valve implantations increased from the early era (N=75), mid era (N=109), to the late era (N=162). The 10-year incidence of valve reintervention was 35%, and was similar between Sapien versus Melody prosthesis (41% versus 33%; P=0.11). The 10-year incidence of all-cause mortality was 13%. There was a temporal increase in prosthetic valve Doppler mean gradient (baseline versus 10 years) for pulmonary (12±5 versus 28±11 mmHg; P<0.001), tricuspid (3±1 versus 8±3 mmHg; P<0.001), and aortic prosthesis (13±5 versus 26±12 mmHg; P<0.001). There was a temporal increase in predicted peak oxygen consumption (absolute ∆, 9% [95% CI, 4-13]; P=0.006) and a decrease in NT-proBNP (N-terminal pro-B-type natriuretic peptide) level (absolute ∆, -138 pg/mL [95% CI, -209 to -64]; P<0.001) at 1-year postintervention.
Conclusions: There has been a temporal increase in the number of transcatheter valve implantations over time. Transcatheter valve replacement was associated with clinical improvement across multiple domains. However, there was a significant increase in prosthetic valve gradient within 10 years of follow-up, suggesting limited prosthesis longevity. There is a need for strategies to improve prosthetic valve longevity, which in turn may improve outcomes in this population.
{"title":"Transcatheter Valve Replacement in Adults With Congenital Heart Disease-The Mayo Clinic Experience.","authors":"Alexander C Egbe, Allison K Cabalka, Nathaniel W Taggart, Donald J Hagler, Mackram F Eleid, Charanjit S Rihal, Jason H Anderson","doi":"10.1161/CIRCINTERVENTIONS.125.015667","DOIUrl":"10.1161/CIRCINTERVENTIONS.125.015667","url":null,"abstract":"<p><strong>Background: </strong>The current study aims to describe outcomes after transcatheter valve replacement in adults with congenital heart disease.</p><p><strong>Methods: </strong>Retrospective study of adults with congenital heart disease who underwent transcatheter valve replacement and had a 1-year follow-up postintervention at Mayo Clinic (2010-2024). The study period was divided into early (2010-2014), mid (2015-2019), and late (2020-2024) eras. The primary outcome was valve reintervention. The secondary outcomes were all-cause mortality and temporal change in prosthetic valve gradient and clinical indices of disease severity.</p><p><strong>Results: </strong>Overall, 341 patients (age 38±17 years; 175 [51%] men) received 346 prostheses (pulmonary [N=236, 68%], tricuspid [N=75, 22%], aortic [N=22, 8%], and mitral [N=7, 2%]). The prostheses were Sapien (N=181, 52%), Melody (N=142, 41%), and Harmony prostheses (N=23, 7%). The number of transcatheter valve implantations increased from the early era (N=75), mid era (N=109), to the late era (N=162). The 10-year incidence of valve reintervention was 35%, and was similar between Sapien versus Melody prosthesis (41% versus 33%; <i>P</i>=0.11). The 10-year incidence of all-cause mortality was 13%. There was a temporal increase in prosthetic valve Doppler mean gradient (baseline versus 10 years) for pulmonary (12±5 versus 28±11 mmHg; <i>P</i><0.001), tricuspid (3±1 versus 8±3 mmHg; <i>P</i><0.001), and aortic prosthesis (13±5 versus 26±12 mmHg; <i>P</i><0.001). There was a temporal increase in predicted peak oxygen consumption (absolute ∆, 9% [95% CI, 4-13]; <i>P</i>=0.006) and a decrease in NT-proBNP (N-terminal pro-B-type natriuretic peptide) level (absolute ∆, -138 pg/mL [95% CI, -209 to -64]; <i>P</i><0.001) at 1-year postintervention.</p><p><strong>Conclusions: </strong>There has been a temporal increase in the number of transcatheter valve implantations over time. Transcatheter valve replacement was associated with clinical improvement across multiple domains. However, there was a significant increase in prosthetic valve gradient within 10 years of follow-up, suggesting limited prosthesis longevity. There is a need for strategies to improve prosthetic valve longevity, which in turn may improve outcomes in this population.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e015667"},"PeriodicalIF":7.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12667561/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145372316","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-10-25DOI: 10.1161/CIRCINTERVENTIONS.125.016022
Kazumasa Ikeda, Takuya Mizukami, Koshiro Sakai, Frederic Bouisset, Jeroen Sonck, Adriaan Wilgenhof, Hitoshi Matsuo, Toshiro Shinke, Hirohiko Ando, Masahiro Hada, Brian Ko, Simone Biscaglia, Fernando Rivero, Thomas Engstrøm, Antonio Maria Leone, Lokien X van Nunen, William F Fearon, Evald Høj Christiansen, Stephane Fournier, Liyew Desta, Andy Yong, Julien Adjedj, Javier Escaned, Masafumi Nakayama, Ashkan Eftekhari, Danielle Keulards, Frederik M Zimmermann, Tatyana Storozhenko, Bruno R da Costa, Gianluca Campo, Colin Berry, Damien Collison, Thomas W Johnson, Daniel Munhoz, Tetsuya Amano, Divaka Perera, Allen Jeremias, Ziad A Ali, Takashi Kubo, Kazuhiro Satomi, Nobuhiro Tanaka, Bernard De Bruyne, Nils P Johnson, Carlos Collet
Background: Impaired flow following percutaneous coronary intervention (PCI) is a known predictor of adverse outcomes. The pullback pressure gradient (PPG) is a novel physiological metric that differentiates focal from diffuse disease and enables prediction of post-PCI fractional flow reserve (FFR). This post hoc analysis of the PPG Global (NCT04789317) study aimed to evaluate the prognostic performance of a PPG model for predicting post-PCI FFR and to determine whether the predicted physiological outcome is associated with adverse events following PCI.
Methods: Prospective and multicenter study including patients with hemodynamically significant coronary artery disease undergoing PCI. A prediction model based on FFR and PPG was used to estimate post-PCI FFR. Based on the predicted values, vessels were classified as having either optimal or suboptimal post-PCI physiology. The primary end point was target vessel failure at 1 year. Target vessel failure was defined as a composite of cardiac death, target-vessel myocardial infarction, and ischemia-driven target vessel revascularization.
Results: A total of 855 patients (890 vessels) were analyzed. The mean difference between predicted and measured post-PCI FFR was 0.001 (limits of agreement, -0.10 to 0.10). There was a strong correlation between predicted and measured delta FFR (r=0.92 [95% CI, 0.91-0.93]; P<0.001). Vessels with predicted suboptimal post-PCI physiology had a significantly higher incidence of target vessel failure (adjusted hazard ratio, 1.97 [95% CI, 1.24-3.15]; P=0.004). Predicted suboptimal physiology was independently associated with adverse clinical outcomes.
Conclusions: PPG-predicted post-PCI physiology was associated with target vessel failure at 1 year. These findings extend the role of coronary physiology beyond diagnostic assessment to include risk stratification and outcome prediction following PCI.
背景:经皮冠状动脉介入治疗(PCI)后血流受损是已知的不良结局预测因素。回拉压力梯度(PPG)是一种新的生理指标,可区分局灶性疾病和弥漫性疾病,并可预测pci后血流储备分数(FFR)。这项对PPG Global (NCT04789317)研究的事后分析旨在评估PPG模型预测PCI后FFR的预后性能,并确定预测的生理结果是否与PCI后不良事件相关。方法:前瞻性、多中心研究,纳入血流动力学显著的冠状动脉疾病(CAD)行PCI的患者。采用基于FFR和PPG的预测模型估计pci后FFR。根据预测值,将血管分为pci术后最佳或次优生理状态。主要终点是1年时靶血管衰竭(TVF)。TVF被定义为心源性死亡、靶血管心肌梗死(MI)和缺血驱动的靶血管重建术的复合。结果:共分析855例患者(890条血管)。预测和测量的pci后FFR之间的平均差异为0.001(一致性限制为-0.10至0.10)。预测和测量的δ FFR之间有很强的相关性(r = 0.92; 95% CI: 0.91-0.93; p < 0.001)。预测pci后生理机能不佳的血管TVF发生率明显较高(校正风险比[HR]: 1.97; 95% CI: 1.24-3.15; p = 0.004)。预测的次优生理与不良临床结果独立相关。结论:ppg预测的pci后生理学与1年时TVF相关。这些发现将冠状动脉生理学的作用从诊断评估扩展到PCI后的风险分层和预后预测。
{"title":"Impact of Pullback Pressure Gradient on Clinical Outcomes after Percutaneous Coronary Interventions.","authors":"Kazumasa Ikeda, Takuya Mizukami, Koshiro Sakai, Frederic Bouisset, Jeroen Sonck, Adriaan Wilgenhof, Hitoshi Matsuo, Toshiro Shinke, Hirohiko Ando, Masahiro Hada, Brian Ko, Simone Biscaglia, Fernando Rivero, Thomas Engstrøm, Antonio Maria Leone, Lokien X van Nunen, William F Fearon, Evald Høj Christiansen, Stephane Fournier, Liyew Desta, Andy Yong, Julien Adjedj, Javier Escaned, Masafumi Nakayama, Ashkan Eftekhari, Danielle Keulards, Frederik M Zimmermann, Tatyana Storozhenko, Bruno R da Costa, Gianluca Campo, Colin Berry, Damien Collison, Thomas W Johnson, Daniel Munhoz, Tetsuya Amano, Divaka Perera, Allen Jeremias, Ziad A Ali, Takashi Kubo, Kazuhiro Satomi, Nobuhiro Tanaka, Bernard De Bruyne, Nils P Johnson, Carlos Collet","doi":"10.1161/CIRCINTERVENTIONS.125.016022","DOIUrl":"10.1161/CIRCINTERVENTIONS.125.016022","url":null,"abstract":"<p><strong>Background: </strong>Impaired flow following percutaneous coronary intervention (PCI) is a known predictor of adverse outcomes. The pullback pressure gradient (PPG) is a novel physiological metric that differentiates focal from diffuse disease and enables prediction of post-PCI fractional flow reserve (FFR). This post hoc analysis of the PPG Global (NCT04789317) study aimed to evaluate the prognostic performance of a PPG model for predicting post-PCI FFR and to determine whether the predicted physiological outcome is associated with adverse events following PCI.</p><p><strong>Methods: </strong>Prospective and multicenter study including patients with hemodynamically significant coronary artery disease undergoing PCI. A prediction model based on FFR and PPG was used to estimate post-PCI FFR. Based on the predicted values, vessels were classified as having either optimal or suboptimal post-PCI physiology. The primary end point was target vessel failure at 1 year. Target vessel failure was defined as a composite of cardiac death, target-vessel myocardial infarction, and ischemia-driven target vessel revascularization.</p><p><strong>Results: </strong>A total of 855 patients (890 vessels) were analyzed. The mean difference between predicted and measured post-PCI FFR was 0.001 (limits of agreement, -0.10 to 0.10). There was a strong correlation between predicted and measured delta FFR (<i>r</i>=0.92 [95% CI, 0.91-0.93]; <i>P</i><0.001). Vessels with predicted suboptimal post-PCI physiology had a significantly higher incidence of target vessel failure (adjusted hazard ratio, 1.97 [95% CI, 1.24-3.15]; <i>P</i>=0.004). Predicted suboptimal physiology was independently associated with adverse clinical outcomes.</p><p><strong>Conclusions: </strong>PPG-predicted post-PCI physiology was associated with target vessel failure at 1 year. These findings extend the role of coronary physiology beyond diagnostic assessment to include risk stratification and outcome prediction following PCI.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e016022"},"PeriodicalIF":7.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145367831","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-11-16DOI: 10.1161/CIRCINTERVENTIONS.125.016067
Philipp von Stein, Jörg Hausleiter, Patrick Horn, Mirjam Kessler, Volker Rudolph, Bernhard Unsöld, Philipp Lurz, Marcel Weber, Niklas Schofer, Mathias H Konstandin, Juan F Granada, Helge Möllmann, Amir Abbas Mahabadi, Tobias Kister, Victor Mauri
{"title":"Pulmonary Artery Systolic Pressure Trajectories After Transcatheter Edge-to-Edge Repair in Atrial and Ventricular Secondary Mitral Regurgitation.","authors":"Philipp von Stein, Jörg Hausleiter, Patrick Horn, Mirjam Kessler, Volker Rudolph, Bernhard Unsöld, Philipp Lurz, Marcel Weber, Niklas Schofer, Mathias H Konstandin, Juan F Granada, Helge Möllmann, Amir Abbas Mahabadi, Tobias Kister, Victor Mauri","doi":"10.1161/CIRCINTERVENTIONS.125.016067","DOIUrl":"10.1161/CIRCINTERVENTIONS.125.016067","url":null,"abstract":"","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e016067"},"PeriodicalIF":7.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145530677","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-11-21DOI: 10.1161/CIRCINTERVENTIONS.125.016177
Neal S Kleiman
{"title":"Pursuit of Perfection: Expanding Our Understanding of Balloon Postdilation During TAVR.","authors":"Neal S Kleiman","doi":"10.1161/CIRCINTERVENTIONS.125.016177","DOIUrl":"10.1161/CIRCINTERVENTIONS.125.016177","url":null,"abstract":"","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e016177"},"PeriodicalIF":7.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145562973","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-11-16DOI: 10.1161/CIRCINTERVENTIONS.125.015864
Kent Chak-Yu So, Darren Walters, Krissada Meemook, Jianqiang Xu, Angel Lai, Chun-Chin Chang, Tawai Ngernsritrakul, Surakiat Leelasithorn, Khin May Thaw, Dale Murdoch, Ching-Wei Lee, Kevin Ka-Ho Kam, Gregory Scalia, Bryan P Yan, Alex Pui-Wai Lee, Gilbert H L Tang, Yat-Yin Lam, Adam S H Sung
{"title":"Single TriClip Steerable Guide for Combined MitraClip and TriClip Transcatheter Edge-to-Edge Repair (STriC-TEER): A Multicenter Experience.","authors":"Kent Chak-Yu So, Darren Walters, Krissada Meemook, Jianqiang Xu, Angel Lai, Chun-Chin Chang, Tawai Ngernsritrakul, Surakiat Leelasithorn, Khin May Thaw, Dale Murdoch, Ching-Wei Lee, Kevin Ka-Ho Kam, Gregory Scalia, Bryan P Yan, Alex Pui-Wai Lee, Gilbert H L Tang, Yat-Yin Lam, Adam S H Sung","doi":"10.1161/CIRCINTERVENTIONS.125.015864","DOIUrl":"10.1161/CIRCINTERVENTIONS.125.015864","url":null,"abstract":"","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e015864"},"PeriodicalIF":7.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145530603","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-11-12DOI: 10.1161/CIRCINTERVENTIONS.125.015161
M Haisum Maqsood, Robert S Zhang, Nil Rawal, Gal Sella, Neal S Kleiman, Sripal Bangalore
Background: Drug-coated balloons (DCBs) are now a Food and Drug Administration-approved treatment option for the management of in-stent restenosis (ISR) based on superior outcomes compared with plain old balloon angioplasty (POBA) alone. However, the efficacy of DCB compared with drug-eluting stent (DES; repeat stenting) for ISR is uncertain, with prior studies showing inferiority of DCB. We aimed to compare the outcomes of DES, DCB, or POBA in patients with coronary ISR.
Methods: We searched PubMed, EMBASE, and clinicaltrials.gov databases (until August 1, 2025) for randomized clinical trials that compared DCB, DES, or POBA alone for ISR. Outcomes included major adverse cardiovascular events, target lesion revascularization, all-cause mortality, cardiovascular mortality, stent thrombosis, late lumen loss, and postprocedure minimum lumen diameter.
Results: From 18 randomized clinical trials that randomized 3820 patients with ISR, at mean follow-up of 18 months, compared with POBA, both DCB and DES were associated with reduction in major adverse cardiovascular events (odds ratio, 0.34 [95% CI, 0.24-0.50]; odds ratio, 0.37 [95% CI, 0.25-0.54]) driven by reduction in target lesion revascularization (odds ratio, 0.28 [95% CI, 0.15-0.50]; odds ratio, 0.21 [95% CI, 0.10-0.42]). DCB had a lower postprocedure minimum lumen diameter but lower late lumen loss (mean difference, -0.16 [95% CI, -0.29 to -0.04] mm) compared with DES with no difference in other clinical outcomes.
Conclusions: In patients with ISR, DCB reduced major adverse cardiovascular events/target lesion revascularization compared with POBA. There was no significant difference in clinical outcomes between DCB and DES.
{"title":"Drug-Eluting Stent, Drug-Coated Balloon, or Plain Old Balloon Angioplasty for In-Stent Coronary Restenosis: Insights From a Mixed Treatment Comparison Meta-Analysis of Randomized Trials.","authors":"M Haisum Maqsood, Robert S Zhang, Nil Rawal, Gal Sella, Neal S Kleiman, Sripal Bangalore","doi":"10.1161/CIRCINTERVENTIONS.125.015161","DOIUrl":"10.1161/CIRCINTERVENTIONS.125.015161","url":null,"abstract":"<p><strong>Background: </strong>Drug-coated balloons (DCBs) are now a Food and Drug Administration-approved treatment option for the management of in-stent restenosis (ISR) based on superior outcomes compared with plain old balloon angioplasty (POBA) alone. However, the efficacy of DCB compared with drug-eluting stent (DES; repeat stenting) for ISR is uncertain, with prior studies showing inferiority of DCB. We aimed to compare the outcomes of DES, DCB, or POBA in patients with coronary ISR.</p><p><strong>Methods: </strong>We searched PubMed, EMBASE, and clinicaltrials.gov databases (until August 1, 2025) for randomized clinical trials that compared DCB, DES, or POBA alone for ISR. Outcomes included major adverse cardiovascular events, target lesion revascularization, all-cause mortality, cardiovascular mortality, stent thrombosis, late lumen loss, and postprocedure minimum lumen diameter.</p><p><strong>Results: </strong>From 18 randomized clinical trials that randomized 3820 patients with ISR, at mean follow-up of 18 months, compared with POBA, both DCB and DES were associated with reduction in major adverse cardiovascular events (odds ratio, 0.34 [95% CI, 0.24-0.50]; odds ratio, 0.37 [95% CI, 0.25-0.54]) driven by reduction in target lesion revascularization (odds ratio, 0.28 [95% CI, 0.15-0.50]; odds ratio, 0.21 [95% CI, 0.10-0.42]). DCB had a lower postprocedure minimum lumen diameter but lower late lumen loss (mean difference, -0.16 [95% CI, -0.29 to -0.04] mm) compared with DES with no difference in other clinical outcomes.</p><p><strong>Conclusions: </strong>In patients with ISR, DCB reduced major adverse cardiovascular events/target lesion revascularization compared with POBA. There was no significant difference in clinical outcomes between DCB and DES.</p><p><strong>Registration: </strong>URL: https://www.crd.york.ac.uk/PROSPERO; Unique identifier: CRD42024598433.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e015161"},"PeriodicalIF":7.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145494682","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-10-10DOI: 10.1161/CIRCINTERVENTIONS.125.015618
Patrick M Sullivan, Evan M Zahn, Shyam Sathanandam, Brian Morray, Shabana Shahanavaz, Arash Salavitabar, Aimee K Armstrong, Diego Porras, Darren P Berman
Background: The Minima Stent System is the first stent designed, tested, and Food and Drug Administration-approved for use in neonates, infants, and children. Our objective was to evaluate the safety and efficacy of Minima implantation for pulmonary artery stenosis (PAS) and coarctation of the aorta (CoA).
Methods: Multicenter, single-arm, prospective, nonrandomized trial. Primary end points included stenosis relief, freedom from device-related serious adverse events or surgical intervention through 6 months, and maintenance of vessel lumen diameter on computed tomography or catheter angiography at 6 months.
Results: Forty-two patients (21 PAS, 15 recurrent CoA, and 6 native CoA) underwent Minima implantation at a median age and weight of 9 (range, 0.4-112) months and 7.8 (3.4-28.3) kg. Implantation was successful in 41 (97.6%) and resulted in a median increase in minimal vessel diameter of 131% (46%-483%) and reduction in median pressure gradients from 25 (0-63) to 0 (0-6; P<0.001) mm Hg in patients with CoA. Two acute PAS stent embolizations occurred; both stents were secured in the contralateral PA, and one was treated with an additional Minima stent. Seven patients with CoA, all under 6 kg, experienced transient femoral artery thrombosis. At 6 months, there were no explants or device-related serious adverse events. Luminal diameter was maintained at 89% (59%-137%) of the implant diameter. During a median follow-up of 596 (412-979) days, 13 (31%; 7 CoA and 6 PAS) patients underwent planned stent expansion without complications.
Conclusions: The Minima system is safe and effective for treating PAS and CoA in infants and small pediatric patients. Luminal patency was preserved, and planned reinterventions for somatic growth seem well-tolerated in early follow-up.
{"title":"Multicenter Pivotal Trial of the Minima Stent for Vascular Stenosis in Infants and Young Children.","authors":"Patrick M Sullivan, Evan M Zahn, Shyam Sathanandam, Brian Morray, Shabana Shahanavaz, Arash Salavitabar, Aimee K Armstrong, Diego Porras, Darren P Berman","doi":"10.1161/CIRCINTERVENTIONS.125.015618","DOIUrl":"10.1161/CIRCINTERVENTIONS.125.015618","url":null,"abstract":"<p><strong>Background: </strong>The Minima Stent System is the first stent designed, tested, and Food and Drug Administration-approved for use in neonates, infants, and children. Our objective was to evaluate the safety and efficacy of Minima implantation for pulmonary artery stenosis (PAS) and coarctation of the aorta (CoA).</p><p><strong>Methods: </strong>Multicenter, single-arm, prospective, nonrandomized trial. Primary end points included stenosis relief, freedom from device-related serious adverse events or surgical intervention through 6 months, and maintenance of vessel lumen diameter on computed tomography or catheter angiography at 6 months.</p><p><strong>Results: </strong>Forty-two patients (21 PAS, 15 recurrent CoA, and 6 native CoA) underwent Minima implantation at a median age and weight of 9 (range, 0.4-112) months and 7.8 (3.4-28.3) kg. Implantation was successful in 41 (97.6%) and resulted in a median increase in minimal vessel diameter of 131% (46%-483%) and reduction in median pressure gradients from 25 (0-63) to 0 (0-6; <i>P</i><0.001) mm Hg in patients with CoA. Two acute PAS stent embolizations occurred; both stents were secured in the contralateral PA, and one was treated with an additional Minima stent. Seven patients with CoA, all under 6 kg, experienced transient femoral artery thrombosis. At 6 months, there were no explants or device-related serious adverse events. Luminal diameter was maintained at 89% (59%-137%) of the implant diameter. During a median follow-up of 596 (412-979) days, 13 (31%; 7 CoA and 6 PAS) patients underwent planned stent expansion without complications.</p><p><strong>Conclusions: </strong>The Minima system is safe and effective for treating PAS and CoA in infants and small pediatric patients. Luminal patency was preserved, and planned reinterventions for somatic growth seem well-tolerated in early follow-up.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT05086016.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e015618"},"PeriodicalIF":7.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145257728","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}