Circulation: Cardiovascular Interventions最新文献

{"title":"Refining Revascularization Strategy in Patients Undergoing TAVR: The Importance of Lesion Location and Severity.","authors":"Tayyab Shah, Yousif Ahmad, Amit N Vora","doi":"10.1161/CIRCINTERVENTIONS.126.017235","DOIUrl":"10.1161/CIRCINTERVENTIONS.126.017235","url":null,"abstract":"","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e017235"},"PeriodicalIF":7.2,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148817659","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":"Impact of Revascularization Completeness on Cardiovascular Outcomes in STEMI With Multivessel Disease.","authors":"Mehdi Madanchi, Natalia Pinilla-Echeverri, David A Wood, Tej Sheth, Robert F Storey, Vijay Kunadian, Gianluca Campo, Raul Moreno, Roxana Mehran, Sunil V Rao, Kevin R Bainey, Tomas Cieza, Helen Nguyen, Thenmozhi Mani, John A Cairns, Shamir R Mehta","doi":"10.1161/CIRCINTERVENTIONS.126.016515","DOIUrl":"10.1161/CIRCINTERVENTIONS.126.016515","url":null,"abstract":"<p><strong>Background: </strong>Complete revascularization is superior to culprit lesion-only percutaneous coronary intervention (PCI) in reducing ischemic events in patients with ST-segment-elevation myocardial infarction and multivessel disease. However, the relationship between the extent of revascularization and the benefits of a complete revascularization strategy remains unclear. The aim of this substudy of the COMPLETE trial (Complete versus Culprit-Only Revascularization Strategies to Treat Multivessel Disease after Early PCI for STEMI) was to evaluate how the degree of anatomic completeness of revascularization, measured by the core laboratory-derived modified residual SYNTAX score (R'SS), relates to major cardiovascular events.</p><p><strong>Methods: </strong>We conducted an exploratory post hoc analysis of the COMPLETE trial (N=3738), stratifying patients randomized in the complete revascularization group based on the R'SS assessed after staged nonculprit lesion-PCI. Complete revascularization was defined by an R'SS=0, whereas incomplete revascularization was defined by an R'SS>0. A stratified Cox proportional hazards model was used, with the culprit-only PCI arm designated as the reference group for comparison. The first coprimary outcome was a composite of cardiovascular death or new myocardial infarction. The second coprimary outcome was a composite of cardiovascular death, new myocardial infarction, or ischemia-driven revascularization.</p><p><strong>Results: </strong>Among patients randomized to a complete revascularization strategy, 90% achieved complete revascularization (R'SS=0), whereas 10% did not (R'SS>0). In patients with R'SS=0, the first coprimary outcome occurred less frequently (6.6%) compared with those randomized to the culprit lesion-only PCI strategy (10.7%; adjusted hazard ratio, 0.61 [95% CI, 0.47-0.78]). Among patients with an R'SS>0, the first coprimary outcome was similar (10.7%) to those in the culprit lesion-only PCI group (10.7%; adjusted hazard ratio, 1.01 [95% CI, 0.61-1.67]). A similar result was observed for the second coprimary outcome.</p><p><strong>Conclusions: </strong>This exploratory analysis of the COMPLETE trial suggests that the benefit of a complete revascularization strategy in patients with ST-segment-elevation myocardial infarction and multivessel disease may be related to the extent of anatomic completeness of revascularization.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT01740479.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e016515"},"PeriodicalIF":7.2,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148148799","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":"Residual Disease, Residual Risk: Does Complete Revascularization Complete the Story After STEMI?","authors":"Zhihao Zhu, Natalia Berry","doi":"10.1161/CIRCINTERVENTIONS.126.017234","DOIUrl":"10.1161/CIRCINTERVENTIONS.126.017234","url":null,"abstract":"","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e017234"},"PeriodicalIF":7.2,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148789068","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":"Optical Coherence Tomography Characterization of Coronary Lithotripsy Following Atherectomy for Treatment of Severely Calcified Lesions.","authors":"Yohei Sotomi, Nehiro Kuriyama, Yutaka Tanaka, Seiji Yamazaki, Tomohiro Kawasaki, Kazushige Kadota, Takashi Muramatsu, Akihiko Takahashi, Takashi Ashikaga, Kenji Ando, Satoru Otsuji, Masaru Ishida, Shigeru Nakamura, Yoshiaki Ito, Raisuke Iijima, Gaku Nakazawa, Junya Shite, Junko Honye, Junya Ako, Hiroyoshi Yokoi, Ken Kozuma, Hiromasa Otake, Tomomi Yamada, Masato Nakamura","doi":"10.1161/CIRCINTERVENTIONS.126.016686","DOIUrl":"10.1161/CIRCINTERVENTIONS.126.016686","url":null,"abstract":"<p><strong>Background: </strong>A combined strategy of atherectomy followed by intravascular lithotripsy (dual-prep strategy) for severely calcified lesions may optimize stent deployment, but mechanistic evidence from prospective optical coherence tomography (OCT) imaging is limited. This study was designed to comprehensively characterize patterns of calcium modification during a dual-preparation strategy and to explore imaging determinants of calcium fracture and stent expansion using serial and 3-dimensional OCT assessment.</p><p><strong>Methods: </strong>This was a prespecified, multicenter, single-arm OCT substudy of the DUAL-PREP (atherectomy Devices and intravascUlAr Lithotripsy for the PREParation of heavy calcified coronary lesions) registry, enrolling patients with severely calcified lesions for whom combined treatment with atherectomy and intravascular lithotripsy was deemed preferable based on imaging findings. OCT was analyzed by an independent core laboratory. Multivariable models examined predictors of fracture and stenting performance, including calcium thickness, length, angle, calcified nodules, and morphology (circumferential, eccentric spiral, and eccentric straight types).</p><p><strong>Results: </strong>OCT images were available for 114 of 118 patients (116 lesions; age, 75.9±9.1 years; 69.3% male). All lesions had an OCT calcium score of 4. Calcium fractures were uncommon after atherectomy (2/106 lesions [1.9%]) but markedly increased following intravascular lithotripsy (89/106 lesions [84.0%]; 2.05±1.59 fractures per lesion), with a further increase after stent implantation (101/109 lesions [92.7%]; 2.89±1.67 fractures per lesion). Final stent expansion index was 0.81±0.15 (eccentricity, 0.72±0.09; asymmetry, 0.39±0.15). Eccentric straight-type calcification was associated with a lower likelihood of fracture at final OCT (odds ratio, 0.07 [95% CI, 0.00-0.77]; <i>P</i>=0.029), whereas eccentric spiral and circumferential types showed higher fracture occurrence.</p><p><strong>Conclusions: </strong>This OCT analysis demonstrated a stepwise increase in calcium fracture during a dual-preparation strategy, with minimal fracture after atherectomy, a marked increase following intravascular lithotripsy, and a further increase after stent implantation. Calcium morphology may provide additional insight into fracture occurrence, supporting the potential value of 3-dimensional assessment in severely calcified lesions.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: jRCT1032230384.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e016686"},"PeriodicalIF":7.2,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13574353/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148403923","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}

{"title":"Antithrombotic Therapy in Patients With Atrial Fibrillation With Prior Complex PCI: A Secondary Analysis of the Randomized ADAPT AF-DES Trial.","authors":"Hong-Ki Jeon, Ho Sung Jeon, Kyounghoon Lee, Yun-Hyeong Cho, Cheol Ung Choi, Sang-Rok Lee, Hyung-Bok Park, Han Cheol Lee, Seunghwan Kim, Sang-Hyup Lee, Yong-Joon Lee, Seung-Jun Lee, Hee Tae Yu, Sung-Jin Hong, Chul-Min Ahn, Byeong-Keuk Kim, Young-Guk Ko, Donghoon Choi, Myeong-Ki Hong, Yangsoo Jang, Hui-Nam Pak, Jung-Sun Kim, Sung Gyun Ahn","doi":"10.1161/CIRCINTERVENTIONS.126.016841","DOIUrl":"10.1161/CIRCINTERVENTIONS.126.016841","url":null,"abstract":"<p><strong>Background: </strong>In patients with atrial fibrillation and chronic coronary syndrome beyond 12 months after percutaneous coronary intervention (PCI), oral anticoagulant monotherapy is recommended by the guideline; however, its efficacy and safety in patients with complex PCI remain uncertain.</p><p><strong>Methods: </strong>We conducted a post hoc analysis of the randomized ADAPT AF-DES trial (Appropriate Duration of Antiplatelet and Thrombotic Strategy After 12 Months in Patients With Atrial Fibrillation Treated With Drug-Eluting Stents), which compared non-vitamin K antagonist oral anticoagulant (NOAC) monotherapy with NOAC plus clopidogrel in patients with atrial fibrillation ≥12 months after second- or third-generation drug-eluting stent implantation. Complex PCI was defined by one of the following characteristics: ≥3 stents, ≥3 lesions, bifurcation with 2 stents, total stent length ≥60 mm, left main PCI, or chronic total occlusion PCI. Net adverse clinical events, ischemic composite outcomes, and bleeding composite outcomes were evaluated according to PCI complexity.</p><p><strong>Results: </strong>Among 960 patients, 247 (25.7%) underwent complex PCI and 713 (74.3%) underwent noncomplex PCI. NOAC monotherapy was associated with a lower risk of net adverse clinical events compared with combination therapy in both the complex PCI group (9.5% versus 21.5%; hazard ratio, 0.42 [95% CI, 0.21-0.83]; <i>P</i>=0.01) and the noncomplex PCI group (9.6% versus 15.7%; hazard ratio, 0.59 [95% CI, 0.39-0.90]; <i>P</i>=0.02), with no significant interaction. Ischemic outcomes were infrequent and did not differ significantly between treatment strategies regardless of PCI complexity, whereas bleeding outcomes were consistently lower with NOAC monotherapy in both complex and noncomplex PCI groups.</p><p><strong>Conclusions: </strong>In this post hoc analysis of the randomized ADAPT AF-DES trial, NOAC monotherapy beyond 12 months after PCI was associated with a substantial reduction in bleeding regardless of PCI complexity. Although limited by low absolute event rates, ischemic outcomes did not differ significantly between treatment strategies. These findings suggest that a bleeding-focused long-term antithrombotic strategy may be reasonable in patients with atrial fibrillation and chronic coronary syndrome, including those with prior complex PCI, although prospective validation remains warranted.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT04250116.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e016841"},"PeriodicalIF":7.2,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148469526","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":"Is There a Golden Hour for Thrombectomy in Intermediate-Risk Pulmonary Embolism? Insights From SYMPHONY-PE.","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.126.016573","DOIUrl":"10.1161/CIRCINTERVENTIONS.126.016573","url":null,"abstract":"<p><strong>Background: </strong>Recent observational studies have suggested that early treatment (<12 hours from diagnosis) of intermediate risk pulmonary embolism (PE) with catheter-based therapies may reduce morbidity and mortality. However, the effect of early versus late mechanical thrombectomy on acute pulmonary hemodynamics and right ventricular mechanics is less well defined.</p><p><strong>Methods: </strong>Patients enrolled in SYMPHONY-PE (Symphony Pulmonary Embolism) trial were divided into one of 2 groups based on the time from baseline computed tomography pulmonary angiography to mechanical thrombectomy: Early <12 hours versus late ≥12 hours. The primary safety end point was the rate of major adverse events within 48 hours, as adjudicated by an academic independent safety board. The primary efficacy end point was the core-lab assessed mean change in right ventricle-to-left ventricle ratio from baseline to 48 hours.</p><p><strong>Results: </strong>Early thrombectomy was performed in 44% (48/109) of patients and was associated with a larger reduction, approaching statistical significance, in right ventricle-to-left ventricle ratio (0.52±0.50 versus 0.37±0.34; <i>P</i>=0.071). Mean pulmonary artery pressure decreased significantly more in patients receiving early thrombectomy (8.6±5.2 versus 5.8±5.0 mm Hg; <i>P</i>=0.006). The major adverse events rate was similar (<i>P</i>=0.431) between groups, and there were no mortalities. The differences in efficacy outcomes were greatest in higher-risk patients per the Composite Pulmonary Embolism Shock score.</p><p><strong>Conclusions: </strong>Early mechanical thrombectomy was associated with larger reductions in right ventricle-to-left ventricle ratio and mean pulmonary artery pressure, with no significant differences in safety event rates compared with patients who underwent late thrombectomy. Randomized trials are needed to test these associations.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT06062329.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e016573"},"PeriodicalIF":7.2,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13574359/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148270580","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}

{"title":"National Changes in Practice Patterns for Noninfarct-Related Artery Revascularization in Patients With STEMI and Multivessel Coronary Artery Disease, 2018 to 2022.","authors":"Sanket S Dhruva, Rebecca Young, Karl E Minges, Hope Caughron, Daniel M Wojdyla, Jeptha P Curtis, Rajesh V Swaminathan","doi":"10.1161/CIRCINTERVENTIONS.126.017010","DOIUrl":"10.1161/CIRCINTERVENTIONS.126.017010","url":null,"abstract":"","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e017010"},"PeriodicalIF":7.2,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148668514","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":"Angiography-Derived FFR Versus IVUS to Guide PCI According to Angiographic Lesion Characteristics.","authors":"Seokhun Yang, Xinyang Hu, Jinlong Zhang, Jin-Eun Song, Jun Jiang, Xiaoping Peng, Dongsheng Lu, Yibin Pan, Lijun Guo, Jilin Li, Wenming He, Hao Zhou, Jun Pu, Jinyu Huang, Fan Jiang, Qiang Liu, Daqing Song, Liang Lu, Zhenfeng Cheng, Bin Yang, Jianliang Ma, Peng Chen, Shiqiang Li, Zhaohui Meng, Lijiang Tang, Yongzhen Fan, Eun-Seok Shin, Shenxian Tu, Chang-Wook Nam, William F Fearon, Jian'an Wang, Bon-Kwon Koo","doi":"10.1161/CIRCINTERVENTIONS.126.016809","DOIUrl":"10.1161/CIRCINTERVENTIONS.126.016809","url":null,"abstract":"<p><strong>Background: </strong>While angiography-derived fractional flow reserve (AngioFFR)- and intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) yield similar outcomes, with AngioFFR associated with lower PCI rates, the relative clinical effectiveness of AngioFFR versus IVUS-guided PCI according to angiographic lesion characteristics remains unclear.</p><p><strong>Methods: </strong>This post hoc analysis of the FLAVOUR II trial (Comparison of Angiography-Derived Fractional Flow Reserve- and Intravascular Ultrasound-Guided Intervention Strategy for Clinical Outcomes in Patients with Coronary Artery Disease) included patients with ≥50% stenosis randomized to AngioFFR- or IVUS-guided PCI. A composite lesion risk score was derived using a marginal Cox model-based linear predictor incorporating % diameter stenosis, lesion length, true bifurcation, ostial lesion, and heavy calcification. The primary end point was target vessel failure (TVF: cardiac death, target vessel myocardial infarction, and target vessel revascularization).</p><p><strong>Results: </strong>Among 1726 patients, 884 (51.2%) underwent AngioFFR-guided PCI and 842 (48.8%) underwent IVUS-guided PCI. During a median 12-month follow-up, TVF occurred in 2.4% of AngioFFR-treated vessels and 1.9% of IVUS-treated vessels (<i>P</i>=0.50). TVF risk increased progressively with a higher composite lesion risk score (adjusted hazard ratio, 2.76 [95% CI, 1.35-5.65]). This association was more pronounced in the AngioFFR group (adjusted hazard ratio, 3.93 [95% CI, 1.79-8.63]) than in the IVUS group (adjusted hazard ratio, 1.62 [95% CI, 0.42-6.22]). Compared with IVUS guidance, AngioFFR-guided vessels with high-risk lesions (score >0.32) had a higher TVF rate (5.1% versus 1.9%; <i>P</i>=0.010), whereas outcomes were comparable in those with low-risk lesions (1.5% versus 1.9%; <i>P</i>=0.531). AngioFFR guidance was associated with lower target vessel PCI rates in low-risk lesions (60.1% versus 76.5%; <i>P</i><0.001), whereas PCI rates were uniformly high and similar between groups in high-risk lesions (96.4% versus 97.4%; <i>P</i>=0.675).</p><p><strong>Conclusions: </strong>A higher composite lesion risk score was associated with increased PCI rates and TVF risk after AngioFFR- or IVUS-guided treatment. AngioFFR guidance was associated with lower PCI rates in low-risk lesions, whereas IVUS guidance may yield more favorable outcomes in high-risk lesions.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT04397211.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e016809"},"PeriodicalIF":7.2,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13574350/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147971014","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}

{"title":"Stability of Compounded Intracoronary Acetylcholine and Implications for Beyond-Use Dating.","authors":"Tatsunori Takahashi, Janet Wei, Allen Ahn, Heidi Hagena, C Noel Bairey Merz, Bruce A Samuels","doi":"10.1161/CIRCINTERVENTIONS.126.017021","DOIUrl":"10.1161/CIRCINTERVENTIONS.126.017021","url":null,"abstract":"","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e017021"},"PeriodicalIF":7.2,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13508566/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148812448","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}

{"title":"Prospective Midterm Outcomes of the PULSTA Self-Expandable Transcatheter Pulmonary Valve: The PULSTA CE Approval Study.","authors":"Sang-Yun Lee, Gi Beom Kim, Mario Carminati, Luca Giugno, Ahmet Çelebi, Ilker Kemal Yucel, Andreas Eicken, Peter Ewert, Stanimir Georgiev, Jae Young Choi, Chang Sin Kim, Federico Gutiérrez-Larraya, Enrique Balbacid Domingo, Ender Odemis, Mete Han Kizilkaya, José Luis Zunzunegui, Fernando Ballesteros Tejerizo, Seong-Ho Kim, So-Ick Jang, Thomas Krasemann, Gregor Krings","doi":"10.1161/CIRCINTERVENTIONS.126.016616","DOIUrl":"10.1161/CIRCINTERVENTIONS.126.016616","url":null,"abstract":"<p><strong>Background: </strong>Patients with congenital or acquired right ventricular outflow tract dysfunction frequently require pulmonary valve replacement and are exposed to repeated surgical interventions due to prosthetic valve degeneration. The PULSTA self-expanding transcatheter pulmonary valve was designed to address a broad spectrum of native and surgically repaired right ventricular outflow tract anatomies. This study reports the midterm safety, hemodynamic performance, and durability outcomes of the prospective, multinational PULSTA CE approval trial (PULSTA Carpentier Edwards).</p><p><strong>Methods: </strong>This premarket, multicenter, nonrandomized study enrolled 58 patients across 11 centers in 6 countries. Successful PULSTA implantation was achieved in 57 patients (98.3%), including 4 valve-in-valve procedures. Patients were followed for a median duration of 4.1 years. Primary end points included procedural or device-related serious adverse events, hemodynamic improvement, and sustained valve function.</p><p><strong>Results: </strong>At 6 months, cardiac magnetic resonance imaging demonstrated significant reverse right ventricular remodeling, with marked reductions in right ventricular end-diastolic volume index, end-systolic volume index, and pulmonary regurgitation fraction (all <i>P</i><0.001). Valve performance remained stable throughout follow-up, with 93.8% of patients exhibiting mild or less pulmonary regurgitation at 4.1 years. Freedom from reintervention was 98.2% at 5 years. One patient required a PULSTA-in-PULSTA implantation due to paravalvular leakage, and one case of infective endocarditis was successfully managed with antibiotic therapy. No stent fractures or structural valve deterioration were observed.</p><p><strong>Conclusions: </strong>The PULSTA transcatheter pulmonary valve demonstrated high procedural success, durable valve function, and sustained hemodynamic benefits. Its adaptability to diverse right ventricular outflow tract anatomies and favorable safety profile supports its role as an effective therapeutic option for patients with right ventricular outflow tract dysfunction.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT03983512.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e016616"},"PeriodicalIF":7.2,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148270555","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}