Circulation: Cardiovascular Interventions最新文献

{"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":"https://doi.org/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":"2025-10-10","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}

{"title":"Complete Revascularization in Older Patients With Myocardial Infarction With or Without Complex Nonculprit Lesions.","authors":"Alberto Sarti, Andrea Erriquez, Beatrice Dal Passo, Gianni Casella, Vincenzo Guiducci, Raul Moreno, Javier Escaned, Federico Marchini, Marta Cocco, Filippo Maria Verardi, Stefano Clò, Serena Caglioni, Jacopo Farina, Emanuele Barbato, Giuseppe Vadalà, Caterina Cavazza, Alessandro Capecchi, Francesco Gallo, Gianluca Campo, Simone Biscaglia","doi":"10.1161/CIRCINTERVENTIONS.125.015902","DOIUrl":"https://doi.org/10.1161/CIRCINTERVENTIONS.125.015902","url":null,"abstract":"<p><strong>Background: </strong>The FIRE trial (Functional Assessment in Elderly Myocardial Infarction Patients With Multivessel Disease) showed the superiority of complete revascularization in older patients with myocardial infarction (MI) and multivessel disease. Whether this result applies equally to patients at higher risk of ischemic events due to nonculprit lesion complexity is unclear.</p><p><strong>Methods: </strong>Overall, 1445 patients were randomized to culprit-only or complete revascularization. In this prespecified analysis, patients were divided into those with or without at least 1 complex nonculprit lesion. A nonculprit lesion was defined as complex if it met any of the following criteria: angiographic heavy calcification, ostial lesion, true bifurcation lesion involving side-branches >2.5 mm, in-stent restenosis, or long-lesions (estimated stent length >28 mm). The primary outcome comprised a composite of death, MI, stroke, or revascularization at 3 years. The key secondary outcome was a composite of cardiovascular death or MI. The safety outcome included a composite of contrast-associated acute kidney injury, stroke, and Bleeding Academic Research Consortium 3 to 5.</p><p><strong>Results: </strong>Overall, 641 patients (44%, complex subgroup) had at least 1 complex nonculprit lesion, whereas 804 patients (56%, noncomplex subgroup) did not. After adjustment for potential confounders, patients in the complex subgroup were at higher risk of 3-year cardiovascular death or MI (hazard risk [HR], 1.32 [95% CI, 1.01-1.74]), MI (HR, 2.33 [95% CI, 1.44-3.78]) and ischemia-driven coronary revascularization (HR, 2.28 [95% CI, 1.46-3.56]). Complete revascularization reduced the primary outcome in both the complex (HR, 0.75 [95% CI, 0.56-0.99]) and noncomplex (HR, 0.71 [95% CI, 0.53-0.95]) subgroups, with no significant interaction (<i>P</i> for interaction=0.625). Similarly, no evidence of heterogeneity related to nonculprit lesion complexity was observed for either key secondary or safety end points.</p><p><strong>Conclusions: </strong>In older patients with MI and multivessel disease, physiology-guided complete revascularization reduced ischemic events, regardless of the complexity of nonculprit lesions.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT03772743.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e015902"},"PeriodicalIF":7.4,"publicationDate":"2025-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145212081","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}

{"title":"Expanding Transcatheter Tricuspid Valve Replacement Applicability-Beyond Device Iterations.","authors":"Muhammed Gerçek, Volker Rudolph, Charles J Davidson","doi":"10.1161/CIRCINTERVENTIONS.125.015960","DOIUrl":"https://doi.org/10.1161/CIRCINTERVENTIONS.125.015960","url":null,"abstract":"","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e015960"},"PeriodicalIF":7.4,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145147740","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}

{"title":"Hemodynamic Super-Responders in Pulmonary Embolism: Optimism and Uncertainty.","authors":"Kevin G Buda, Samuel Horr, Ann Gage","doi":"10.1161/CIRCINTERVENTIONS.125.015962","DOIUrl":"https://doi.org/10.1161/CIRCINTERVENTIONS.125.015962","url":null,"abstract":"","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e015962"},"PeriodicalIF":7.4,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145147778","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}

{"title":"Aspirin Versus Clopidogrel Beyond 1 Month After PCI in Patients With Oral Anticoagulation.","authors":"Masahiro Natsuaki, Hirotoshi Watanabe, Takeshi Morimoto, Ko Yamamoto, Yuki Obayashi, Ryusuke Nishikawa, Tomoya Kimura, Kenji Ando, Satoru Suwa, Tsuyoshi Isawa, Hiroyuki Takenaka, Tetsuya Ishikawa, Toshihiro Tamura, Kandoh Kawahatsu, Fujio Hayashi, Masaharu Akao, Takeshi Serikawa, Hiroyoshi Mori, Takayuki Kawamura, Arata Hagikura, Naoki Shibata, Koh Ono, Takeshi Kimura","doi":"10.1161/CIRCINTERVENTIONS.125.015495","DOIUrl":"https://doi.org/10.1161/CIRCINTERVENTIONS.125.015495","url":null,"abstract":"<p><strong>Background: </strong>There were no previous studies comparing aspirin with clopidogrel on top of oral anticoagulation (OAC) within 1 year after percutaneous coronary intervention when dual therapy with OAC and clopidogrel was recommended.</p><p><strong>Methods: </strong>We conducted a subgroup analysis stratified by OAC in the 1-year follow-up of the STOPDAPT-3 trial (Short and Optimal Duration of Dual Antiplatelet Therapy-3), which randomly compared 1-month dual antiplatelet therapy followed by aspirin monotherapy (aspirin group) with 1-month prasugrel monotherapy followed by clopidogrel monotherapy (clopidogrel group). This subgroup analysis compared aspirin with clopidogrel in patients with or without OAC by the 30-day landmark analysis. The coprimary end points were the cardiovascular (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke), and bleeding end points (Bleeding Academic Research Consortium 3 or 5).</p><p><strong>Results: </strong>In the 30-day landmark analysis (N=5809), there were 788 patients (13.6%) with OAC at discharge. Regardless of OAC, the incidence rates beyond 30 days up to 1 year were similar between the aspirin and clopidogrel groups for cardiovascular end point (OAC: 3.7% versus 3.9%, hazard ratio, 0.92 [95% CI, 0.44-1.93]; no OAC: 3.7% versus 3.6%; hazard ratio, 1.03 [95% CI, 0.77-1.38]; <i>P</i> interaction=0.78) and for bleeding end point (OAC: 3.5% versus 4.2%, hazard ratio, 0.82 [95% CI, 0.39-1.73]; no OAC 1.5% versus 1.4%, hazard ratio, 1.07 [95% CI, 0.66-1.72]; <i>P</i> interaction=0.57).</p><p><strong>Conclusions: </strong>Aspirin compared with clopidogrel was associated with similar cardiovascular and bleeding outcomes beyond 30 days and up to 1 year after percutaneous coronary intervention regardless of OAC at discharge.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT04609111.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e015495"},"PeriodicalIF":7.4,"publicationDate":"2025-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145130230","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}

{"title":"Long-Term Impact of Platelet Reactivity and Clinical Risk on Clinical Outcomes in Patients With Coronary Artery Disease: Analysis of the PTRG-DES Registry.","authors":"Jeehoon Kang, Sungjoon Park, Kyung Woo Park, Hyung Joon Joo, Kiyuk Chang, Yongwhi Park, Young Bin Song, Sung Gyun Ahn, Jung-Won Suh, Sang Yup Lee, Jung Rae Cho, Ae-Young Her, Young-Hoon Jeong, Byeong-Keuk Kim, Moo Hyun Kim, Eun-Seok Shin, Do-Sun Lim, Doyeon Hwang, Jung-Kyu Han, Han-Mo Yang, Bon-Kwon Koo, Hyo-Soo Kim","doi":"10.1161/CIRCINTERVENTIONS.125.015737","DOIUrl":"https://doi.org/10.1161/CIRCINTERVENTIONS.125.015737","url":null,"abstract":"<p><strong>Background: </strong>Platelet reactivity (PR) and clinical risk factors are known to have impact on outcomes in patients receiving percutaneous coronary intervention (PCI). We aimed to assess the interaction of PR and clinical risk assessment using the Thrombolysis in Myocardial Infarction Risk Score for Secondary Prevention (TRS2P) on adverse clinical outcomes following PCI.</p><p><strong>Methods: </strong>From the PTRG-DES (Platelet function and Genotype-Related Long-Term Prognosis in Drug-Eluting Stent-Treated Patients With Coronary Artery Disease) registry, 11 714 patients who underwent PCI and had a mean platelet reactivity unit (PRU) value were studied. Clinical risk was stratified using the TRS2P as low clinical risk (score 0-1) or high clinical risk (≥2), and PR was stratified as high PR (HPR, PRU ≥252) and non-HPR (PRU <252). The primary outcome was a composite of cardiac death, myocardial infarction, and stent thrombosis. Landmark analysis was performed at 1- and 12 months after PCI.</p><p><strong>Results: </strong>Among total population, mean PRU was 217.8±78.7, and mean TRS2P was 1.56±1.12. Over the long-term follow-up period, the primary outcome occurred in 335 (5.3%) patients. Patients with both high clinical risk and HPR had the highest incidence of the primary outcome (9.4%), followed by high clinical risk/non-HPR (5.9%), low clinical risk/HPR (4.8%), and low clinical risk/non-HPR (3.9%) (<i>P</i><0.001). Compared with low clinical risk/non-HPR patients, those with both high clinical risk and HPR had a 3.25-fold higher risk of the primary outcome (hazard ratio, 3.25 [95% CI, 2.38-4.42]; <i>P</i><0.001). Both PRU and TRS2P were independent predictors of the primary outcome. In landmark analyses, the risk of primary outcome within 1 month after PCI were mainly determined by PRU, while outcome beyond 1 month after PCI was mainly determined by TRS2P.</p><p><strong>Conclusions: </strong>In the secondary prevention after percutaneous coronary intervention, platelet reactivity and clinical risk had additive value in predicting outcomes. Platelet reactivity had greater relative impact within 1 month while clinical risk had greater relative impact beyond 1 month.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT04734028.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e015737"},"PeriodicalIF":7.4,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145112075","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}

{"title":"Microvascular and Macrovascular Disease: The S'mores of Peripheral Artery Disease.","authors":"Ulf Neisius, Scott Kinlay","doi":"10.1161/CIRCINTERVENTIONS.125.015961","DOIUrl":"https://doi.org/10.1161/CIRCINTERVENTIONS.125.015961","url":null,"abstract":"","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e015961"},"PeriodicalIF":7.4,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145112052","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}

{"title":"Patterns of Restenosis After Left Main Bifurcation Single- or Dual-Stenting: An EBC MAIN Trial Subanalysis.","authors":"Annette Maznyczka, Sandeep Arunothayaraj, Adrian P Banning, Thomas Schmitz, Adrian Wlodarczak, Marc Silvestri, Mohaned Egred, René Koning, Mark S Spence, Marie-Claude Morice, Thierry Lefevre, Miroslaw Ferenc, James Cockburn, Andrejs Erglis, Philippe Brunel, Francesco Burzotta, Evgeny Kretov, Thomas Hovasse, Manuel Pan, Gerald Clesham, Alaide Chieff, Darren Mylotte, Mitchell Lindsay, Evald H Christiansen, Frédéric Bouisset, Beatriz Vaquerizo, Jens Flensted Lassen, Olivier Darremont, Yves Louvard, Goran Stankovic, David Hildick-Smith","doi":"10.1161/CIRCINTERVENTIONS.125.015546","DOIUrl":"https://doi.org/10.1161/CIRCINTERVENTIONS.125.015546","url":null,"abstract":"<p><strong>Background: </strong>In the randomized EBC MAIN trial (European Bifurcation Club Left Main Coronary Stent), target lesion revascularization at 3 years poststenting of left main (LM) bifurcations was more frequent with upfront dual-stenting compared with the stepwise provisional approach. Restenosis location and its relation to stent technique are poorly characterized. The aim of this study was to investigate restenosis location after LM bifurcation stenting, and the impact of stent implantation technique.</p><p><strong>Methods: </strong>Patients from the EBC MAIN trial who underwent target lesion revascularization during the 3-year follow-up had restenosis location assessed by the core laboratory. Restenosis was defined as ≥50% lesion diameter stenosis.</p><p><strong>Results: </strong>Among 48 patients with target lesion revascularization (mean age 70.3±10.6 years, 72.9% male), 31 were randomized to and treated with upfront dual-stenting, while 17 were randomized to the stepwise provisional technique, of whom 4 had dual-stent implantation. The treatment groups therefore comprised 35 dual-stented and 13 single-stented patients. The commonest pattern of subsequent restenosis was isolated ostial circumflex restenosis (58% of patients), regardless of dual- or single-stent implantation. The ostial circumflex was the culprit lesion for target lesion revascularization in 34 (71%) patients overall (dual- versus single-stented patients: 77% versus 54%; <i>P</i>=0.115). During the 3-year follow-up, the mean % diameter stenosis at the circumflex ostium was similar after dual- versus single-stent implantation (64.6% versus 60.5%, coefficient, -0.12 [95% CI, -0.46 to 0.22]; <i>P</i>=0.473). Single stenting from LM to the circumflex artery was associated with worse subsequent mean % diameter stenosis in the ostium of the left anterior descending artery versus single stenting from LM- left anterior descending (49.8% versus 19.8%, coefficient, 0.57 [95% CI, 0.003-1.13]; <i>P</i>=0.049).</p><p><strong>Conclusions: </strong>The circumflex ostium is the commonest site requiring revascularization after LM bifurcation stenting, irrespective of whether 1 or 2 stents were deployed. Strategies are needed to improve the long-term success of percutaneous coronary intervention to the circumflex artery ostium.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT02497014.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e015546"},"PeriodicalIF":7.4,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145074657","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}

{"title":"Prospective Multicenter IDE Study of the Next-Generation Precision Aspiration Thrombectomy System for Intermediate-Risk Pulmonary Embolism: The SYMPHONY-PE Trial.","authors":"Sripal Bangalore, R Dana Tomalty, Herman Kado, Sameh Sayfo, Adam Raskin, Arman Qamar, Andres Vargas Estrada, Kirema Garcia-Reyes, H Gabriel Lipshutz, Srinivas Yallapragada, Sabah Butty, Sagar Gandhi, David Dexter, Justin Trivax, Farhan Ali, Michael Knox, Christopher Ramos, Youssef Al-Saghir, Vivian Bishay","doi":"10.1161/CIRCINTERVENTIONS.125.015815","DOIUrl":"https://doi.org/10.1161/CIRCINTERVENTIONS.125.015815","url":null,"abstract":"<p><strong>Background: </strong>Mechanical thrombectomy offers a promising alternative to thrombolytic-based approaches for reducing thrombus burden and right heart strain in acute pulmonary embolism. This pivotal Food and Drug Administration-approval trial evaluated the safety and efficacy of the Symphony Thrombectomy System (Imperative Care, Inc, Campbell, CA) in acute intermediate-risk pulmonary embolism.</p><p><strong>Methods: </strong>Patients with intermediate-risk pulmonary embolism (systolic blood pressure ≥90 mm Hg; right ventricle-to-left ventricle ratio >0.9) were enrolled without roll-ins. The primary safety end point was the rate of major adverse events within 48 hours, defined as a composite of all-cause major bleeding, device-related mortality, and serious device-related events, adjudicated by an academic independent safety board. The primary efficacy end point was the core laboratory-assessed mean change in right ventricle-to-left ventricle ratio from baseline to 48 hours. Prespecified performance goals were set for both. Exploratory end points included immediate postprocedure change in mean pulmonary artery pressure and change in modified Miller index at 48 hours. Safety was assessed in the intention-to-treat cohort and efficacy in the modified intention-to-treat cohort, excluding patients receiving nonstudy device treatments.</p><p><strong>Results: </strong>Between December 2023 and May 2025, 109 patients were treated at 17 US centers (intention-to-treat), with 106 in the modified intention-to-treat cohort. The major adverse events rate was 0.9% (1/109), with an upper 97.5% CI of 5.7%, meeting the <15% safety goal (<i>P</i><0.001). No device-related clinical deterioration, pulmonary vascular injury, or cardiac injury occurred at 48 hours; no mortality occurred through 30 days. The mean right ventricle-to-left ventricle ratio decrease was 0.44, with a lower 97.5% CI of 0.36, exceeding the >0.20 performance goal (<i>P</i><0.001). Mean pulmonary artery pressure decreased from 29.1±7.2 to 22.2±6.6 mm Hg (24%) and the modified Miller index from 24.2±4.1 to 14.9±5.4 (38%), both <i>P</i><0.001.</p><p><strong>Conclusions: </strong>These data support the safety and effectiveness of the Symphony Thrombectomy System in patients with acute intermediate-risk pulmonary embolism.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT06062329.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e015815"},"PeriodicalIF":7.4,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145079776","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}

{"title":"Device-Related Findings on Computed Tomography After Transcatheter Pulmonary Valve Replacement With the Harmony Valve.","authors":"Sujatha Buddhe, Shiraz A Maskatia, Ayush Jaggi, Christiane Haeffele, Frandics P Chan, Doff B McElhinney","doi":"10.1161/CIRCINTERVENTIONS.125.015186","DOIUrl":"https://doi.org/10.1161/CIRCINTERVENTIONS.125.015186","url":null,"abstract":"<p><strong>Background: </strong>Self-expanding transcatheter pulmonary valves (TPV) offer a promising alternative to surgical valve replacement in patients with a large patched or native right ventricular outflow tract. Little is known about remodeling of the implanted valve or valve-anatomy interactions.</p><p><strong>Methods: </strong>We reviewed all patients who underwent TPV replacement with the Harmony valve (Medtronic, Inc) at our center and had a postimplant computed tomography angiogram.</p><p><strong>Results: </strong>Of 63 patients who underwent TPV replacement, 36 had a computed tomography angiogram performed 0.2 to 4.9 years (median 1 year) after implant, in most cases for surveillance. Hypoattenuated leaflet thickening was identified in 28% of patients and tissue ingrowth/thickening on the luminal aspect of the device was observed in 39%. In most cases, these findings were mild and were not associated with valve stenosis or regurgitation. Most patients were discharged after TPV replacement on aspirin without anticoagulation, but addition of oral anticoagulants reversed TPV replacement in 2 patients who underwent a second follow-up computed tomography angiogram 6 months later. New frame deformation and stent fracture were uncommon, and erosion of the valve through the pulmonary artery did not occur. The outflow portion of the TPV frame was frequently close to the left coronary artery, but did not cause compression.</p><p><strong>Conclusions: </strong>This study provides novel data related to hypoattenuated leaflet thickening, tissue ingrowth within the TPV frame, and proximity of the implanted valve to the coronary arteries, which should help clinicians evaluate and manage patients before and after Harmony valve implant.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e015186"},"PeriodicalIF":7.4,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145074591","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}