{"title":"Response by Abd Razak et al to Letter Regarding Article, \"Prospective Validation of the MIRACLE2 Score for Early Neurological Stratification After Out-of-Hospital Cardiac-Arrest: The GLOBAL-MIRACLE Registry\".","authors":"Muhamad Abd Razak, Jonathan Byrne, Nilesh Pareek","doi":"10.1161/CIRCINTERVENTIONS.126.016923","DOIUrl":"10.1161/CIRCINTERVENTIONS.126.016923","url":null,"abstract":"","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e016923"},"PeriodicalIF":7.2,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147940270","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}
Bruno Melica, Shemy Carasso, Adi Butnaru, Irakli Gogorishvili, Mikhael Metreveli, Thomas Modine, Levan Kurashvili, Rivka Farkash, David Meerkin
{"title":"Transeptal Mitral Annuloplasty With the AMEND System: 6-Month Results of First in Man Cohort.","authors":"Bruno Melica, Shemy Carasso, Adi Butnaru, Irakli Gogorishvili, Mikhael Metreveli, Thomas Modine, Levan Kurashvili, Rivka Farkash, David Meerkin","doi":"10.1161/CIRCINTERVENTIONS.125.015977","DOIUrl":"10.1161/CIRCINTERVENTIONS.125.015977","url":null,"abstract":"<p><strong>Background: </strong>The AMEND implant is a semi-rigid closed D-shaped annuloplasty ring deployed through a transvenous transeptal approach. It is aimed to affect selective anteroposterior dimensional reduction, improving leaflet coaptation, and reduce mitral regurgitation (MR). We report the 6-month outcomes of the first cohort treated.</p><p><strong>Methods: </strong>Thirteen patients with the grade 3 or 4 functional MR were treated in 2 studies in Georgia and Israel, and with compassionate approvals in Portugal and France. They underwent mitral repair with the AMEND annuloplasty and were followed for 6 months.</p><p><strong>Results: </strong>There were no deaths, myocardial infarctions, strokes or cardiac surgery. There were 2 pericardial effusions, 1 acute and the second at 4 months. There was no anchor disengagement or device dehiscence over the follow-up period. There was a single patient who was readmitted with heart failure, and the iatrogenic atrial septal defect was closed. At 6 months the overall anteroposterior dimensional reduction achieved acutely was maintained, with MR reduction being stable, with 11 of 13 patients with ≤grade 1 MR.</p><p><strong>Conclusions: </strong>In this small multicenter cohort of patients, the AMEND annuloplasty procedure demonstrated promising safety, with stable and significant reduction of MR maintained over the 6-month follow-up period.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e015977"},"PeriodicalIF":7.2,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13281969/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147638252","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}
Antonin Trimaille, Marisa Avvedimento, Guylaine Gleeton, Juan Hernando Del Portillo, Carlos Giuliani, Pablo Vidal-Calés, Carlos Real, Jean-Michel Paradis, Siamak Mohammadi, Anthony Poulin, Frederic Beaupré, Jean Porterie, Dimitri Kalavrouziotis, Eric Dumont, Emilie Pelletier-Beaumont, Josep Rodés-Cabau
{"title":"Subclinical Leaflet Thrombosis in Transcatheter SAPIEN 3 Ultra RESILIA Bioprosthetic Valves.","authors":"Antonin Trimaille, Marisa Avvedimento, Guylaine Gleeton, Juan Hernando Del Portillo, Carlos Giuliani, Pablo Vidal-Calés, Carlos Real, Jean-Michel Paradis, Siamak Mohammadi, Anthony Poulin, Frederic Beaupré, Jean Porterie, Dimitri Kalavrouziotis, Eric Dumont, Emilie Pelletier-Beaumont, Josep Rodés-Cabau","doi":"10.1161/CIRCINTERVENTIONS.125.016439","DOIUrl":"10.1161/CIRCINTERVENTIONS.125.016439","url":null,"abstract":"","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e016439"},"PeriodicalIF":7.2,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147764443","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":"Cardiac Structural Complications in TAVR: A Persistent Challenge in the Modern Era.","authors":"R David Anderson, Faiz Ali Saulat","doi":"10.1161/CIRCINTERVENTIONS.126.016550","DOIUrl":"10.1161/CIRCINTERVENTIONS.126.016550","url":null,"abstract":"","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e016550"},"PeriodicalIF":7.4,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147728664","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":"Precision Antiplatelet Therapy: The Promise and Complexity of Pharmacogenomic Antiplatelet Therapy.","authors":"Carine E Hamo, Jeffrey S Berger","doi":"10.1161/CIRCINTERVENTIONS.126.016678","DOIUrl":"10.1161/CIRCINTERVENTIONS.126.016678","url":null,"abstract":"","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e016678"},"PeriodicalIF":7.4,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147764402","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}
Michael R Hainstock, Gregory Fleming, Dennis Kim, Jamil Aboulhosn, Daniel Levi, Richard Krasuski, Robert Sommer, Alejandro J Torres, Robert Gray, Dean Kereiakes, Andrew Leventhal, Matthew Gillespie, Wilson Szeto, Alan Zajarias, Shabana Shahanavaz, Zachary L Steinberg, Thomas K Jones, Vaikom S Mahadevan, Phillip Moore, Sammy Elmariah, Girish Shirali, Wenhao Li, Vasilis Babaliaros, D Scott Lim
{"title":"Five-Year Outcomes for Patients With RVOT Dysfunction Treated With the SAPIEN 3 Transcatheter Heart Valve: A Pooled Analysis From the COMPASSION S3 Trial.","authors":"Michael R Hainstock, Gregory Fleming, Dennis Kim, Jamil Aboulhosn, Daniel Levi, Richard Krasuski, Robert Sommer, Alejandro J Torres, Robert Gray, Dean Kereiakes, Andrew Leventhal, Matthew Gillespie, Wilson Szeto, Alan Zajarias, Shabana Shahanavaz, Zachary L Steinberg, Thomas K Jones, Vaikom S Mahadevan, Phillip Moore, Sammy Elmariah, Girish Shirali, Wenhao Li, Vasilis Babaliaros, D Scott Lim","doi":"10.1161/CIRCINTERVENTIONS.125.016361","DOIUrl":"10.1161/CIRCINTERVENTIONS.125.016361","url":null,"abstract":"<p><strong>Background: </strong>The COMPASSION S3 trial (Congenital Multicenter Trial of Pulmonic Valve Dysfunction Studying the SAPIEN 3 Interventional Transcatheter Heart Valve) was designed to evaluate the safety and effectiveness of the SAPIEN 3 transcatheter heart valve (THV) for transcatheter pulmonic valve replacement in patients with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position. Here, 5-year clinical and hemodynamic outcomes for patients in the main cohort and the continued access protocol are reported.</p><p><strong>Methods: </strong>The COMPASSION S3 trial was a single-arm, multicenter study enrolling patients with either moderate-to-severe pulmonic regurgitation, a mean RVOT gradient ≥35 mm Hg, or both. The primary end point was THV dysfunction at 1 year, a nonhierarchical composite of RVOT reintervention, ≥moderate total pulmonic regurgitation, and mean RVOT gradient >40 mm Hg. Clinical and echocardiographic outcomes were assessed at baseline, discharge, 30 days, 6 months, 1 year, and then annually to 5 years.</p><p><strong>Results: </strong>Between 2016 and 2020, 69 patients were enrolled and successfully implanted with the SAPIEN 3 THV. The mean patient age was 32.1 years, and most patients (70.8%) had a conduit as the most recent prior intervention. At 5 years, the rate of THV dysfunction was 12.0%: 3 patients required reintervention, 2 patients had ≥moderate pulmonic regurgitation, and 1 patient had a mean gradient >40 mm Hg. There were 3 cases of device-related endocarditis (4.4%). One death occurred on postoperative day 560 due to cardiogenic shock. No cases of tricuspid valve injury, stent fractures, or valve malposition were reported. Post-transcatheter pulmonic valve replacement, mean gradients were low and stable through 5-year follow-up. Through 5 years, >95% of patients had ≤mild total pulmonic regurgitation, and 97.9% of patients had none/trace paravalvular regurgitation.</p><p><strong>Conclusions: </strong>Five-year results from the COMPASSION S3 trial demonstrate that the SAPIEN 3 THV provides durable RVOT relief with low rates of reintervention or endocarditis, supporting the device as a safe and versatile option for transcatheter pulmonic valve replacement across diverse anatomies and clinical scenarios.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT02744677.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e016361"},"PeriodicalIF":7.2,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147510021","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}
Chieh Yang Christopher Koo, Siling Li, Rasha Al-Lamee, David J Cohen, William F Fearon, Ajay J Kirtane, Martin B Leon, Guy Witberg, Robert W Yeh, Eric A Secemsky
{"title":"Angiography-Derived Fractional Flow Reserve During Percutaneous Coronary Intervention.","authors":"Chieh Yang Christopher Koo, Siling Li, Rasha Al-Lamee, David J Cohen, William F Fearon, Ajay J Kirtane, Martin B Leon, Guy Witberg, Robert W Yeh, Eric A Secemsky","doi":"10.1161/CIRCINTERVENTIONS.125.016213","DOIUrl":"10.1161/CIRCINTERVENTIONS.125.016213","url":null,"abstract":"<p><strong>Background: </strong>Angiography-derived fractional flow reserve (Angio-FFR) is an emerging tool for guiding percutaneous coronary intervention (PCI). Its uptake and outcomes compared with pressure wire (PW)-based assessment in the United States are unknown.</p><p><strong>Methods: </strong>We conducted a cohort study using US Medicare beneficiary data from January 1, 2019 to December 31, 2024. Propensity score matching (1:3) of Angio-FFR to PW was performed in patients who underwent PCI during the same procedure, and separately among those who did not undergo PCI during the same procedure. The primary outcome was the cumulative incidence of major adverse cardiovascular events through 2 years, including all-cause death, myocardial infarction, and repeat revascularization. Secondary outcomes included individual major adverse cardiovascular event components, 30-day acute kidney injury, and 30-day major bleeding. Falsification end points (hospitalization for pneumonia and hip fracture) were used to assess unmeasured confounding.</p><p><strong>Results: </strong>Of 466 535 angiograms that included intraprocedural physiological assessment, 1.00% (N=4672) used Angio-FFR. Annual use increased from 0.47% in 2019 to 3.85% in 2024. Among patients with PCI, 1591 Angio-FFR and 4773 PW-matched patients with PCI had similar major adverse cardiovascular event rates through 2 years (24.8% versus 23.5%; hazard ratio, 1.01 [95% CI, 0.85-1.20]). Secondary outcomes and falsification end points were not significantly different. In non-PCI patients, 2532 Angio-FFR and 7596 PW-matched patients also had similar major adverse cardiovascular events through 2 years (24.1% versus 23.9%; hazard ratio, 0.97 [95% CI, 0.84-1.11]).</p><p><strong>Conclusions: </strong>Angio-FFR usage in the United States is modest but increasing. Angio-FFR guidance during angiography versus PW was associated with comparable outcomes through 2 years.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e016213"},"PeriodicalIF":7.2,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147372319","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}
Yasser M Sammour, John A Spertus, Nathaniel R Smilowitz, Huaying Dong, Pratik B Sandesara, Sachin S Goel, Safi U Khan, Alpesh Shah, Philip Jones, Natalie Wheeler, Yang Song, Tanveer Rab, William J Nicholson, Wissam A Jaber, Rishi K Wadhera, Neal S Kleiman
{"title":"Hospital-Level Variability in NSTEMI Management: Findings From the NCDR Chest Pain-MI Registry.","authors":"Yasser M Sammour, John A Spertus, Nathaniel R Smilowitz, Huaying Dong, Pratik B Sandesara, Sachin S Goel, Safi U Khan, Alpesh Shah, Philip Jones, Natalie Wheeler, Yang Song, Tanveer Rab, William J Nicholson, Wissam A Jaber, Rishi K Wadhera, Neal S Kleiman","doi":"10.1161/CIRCINTERVENTIONS.126.016534","DOIUrl":"10.1161/CIRCINTERVENTIONS.126.016534","url":null,"abstract":"<p><strong>Background: </strong>Although guidelines recommend invasive management for non-ST-segment-elevation myocardial infarction (NSTEMI), there is considerable variability in the application of these recommendations across different hospitals, reflecting a lack of standardized clinical pathways and highlighting ongoing uncertainty in real-world practice. We sought to describe site-level variability in the use and timing of invasive angiography for NSTEMI and its association with in-hospital outcomes.</p><p><strong>Methods: </strong>Using National Cardiovascular Data Registry Chest Pain-MI registry data (2019-2024), the rates and timing of invasive coronary angiography, if any, were characterized among patients with NSTEMI. Hierarchical logistic regression models were created to describe hospital-level variability in management using median odds ratios, adjusted for patient and site characteristics. Inverse probability weighting was used to estimate the association between treatment strategy and in-hospital outcomes.</p><p><strong>Results: </strong>We included 287 275 patients with type-1 NSTEMI from 541 hospitals (age, 67.6±13.3 years; 36.4% women). Invasive coronary angiography was performed in 87.1%, of whom 56.9% within 24 hours. Among those treated invasively, 66.1% received percutaneous coronary intervention. Older patients with more comorbidities were paradoxically more likely to receive conservative management or delayed intervention (>24 hours). Site-level variability for invasive strategy (versus conservative) was large (median odds ratio, 2.85 (95% CI, 2.64-3.10]), as was early invasive treatment (median odds ratio, 1.67 [95% CI, 1.62-1.74]), particularly on weekends/holidays (median odds ratio, 1.89 [95% CI, 1.81-1.98]). The use of any invasive strategy was associated with lower in-hospital mortality versus conservative management (weighted odds ratio, 0.36 [95% CI, 0.31-0.42]). This finding was consistent across all baseline risk categories (<i>P</i><sub>interaction</sub><0.001).</p><p><strong>Conclusions: </strong>Patients with type-1 NSTEMI and higher-risk clinical profiles were not consistently prioritized to undergo early invasive management with substantial variability across hospitals. Invasive management was associated with lower in-hospital mortality compared with conservative treatment. Future randomized studies in the modern percutaneous coronary intervention era are needed to confirm our findings and identify which patients benefit most and when intervention should occur.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e016534"},"PeriodicalIF":7.2,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147372295","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}
Wout W A van den Broek, Jaouad Azzahhafi, Qiu Ying F van de Pol, Dean R P P Chan Pin Yin, Niels M R van der Sangen, Shabiga Sivanesan, J Peper, Ankie M Harmsze, Ronald J Walhout, Melvyn Tjon Joe Gin, Nicoline J Breet, Jorina Langerveld, Yolande Appelman, Ron H N van Schaik, José P S Henriques, Wouter J Kikkert, Jurriën M Ten Berg
{"title":"Genotype-Guided P2Y<sub>12</sub>-Inhibitor De-Escalation Strategy in Acute Coronary Syndrome: Observational Evidence From the POPular-GUIDE PCI.","authors":"Wout W A van den Broek, Jaouad Azzahhafi, Qiu Ying F van de Pol, Dean R P P Chan Pin Yin, Niels M R van der Sangen, Shabiga Sivanesan, J Peper, Ankie M Harmsze, Ronald J Walhout, Melvyn Tjon Joe Gin, Nicoline J Breet, Jorina Langerveld, Yolande Appelman, Ron H N van Schaik, José P S Henriques, Wouter J Kikkert, Jurriën M Ten Berg","doi":"10.1161/CIRCINTERVENTIONS.125.016084","DOIUrl":"10.1161/CIRCINTERVENTIONS.125.016084","url":null,"abstract":"<p><strong>Background: </strong>A genotype-guided de-escalation strategy-switching from a potent P2Y<sub>12</sub> inhibitor to clopidogrel-may reduce bleeding risk in patients with acute coronary syndrome. This analysis evaluated the safety and effectiveness of routine genetic testing to guide antiplatelet therapy in clinical practice.</p><p><strong>Methods: </strong>In this investigator-initiated, prospective, multicenter implementation study, patients received either standard care, with antiplatelet therapy at the physician discretion, or genotype-guided therapy. In the genotype-guided group, physicians were recommended to switch to clopidogrel in noncarriers of <i>CYP2C19</i> loss-of-function alleles. The coprimary end points were major adverse cardiac events, a composite of cardiovascular death, myocardial infarction, or stroke, and major or nonmajor clinically relevant bleeding, at 1 year of follow-up. Hazard ratios were adjusted for baseline differences between cohorts using multivariable Cox regression. Net adverse cardiac events comprised all-cause death, myocardial infarction, stroke, stent thrombosis, and major bleeding. A Bonferroni-adjusted significance level of <i>α</i>=0.025 was applied.</p><p><strong>Results: </strong>A total of 9907 patients were included in the analysis. Of these, 1208 (12%) were included in the genotype-guided cohort, whereas 8699 (88%) were assigned to the standard care cohort. Major adverse cardiac events occurred in 107 patients (8.9%) in the genotype-guided cohort and 897 patients (10.3%) in the standard care cohort (adjusted hazard ratio, 1.05 [95% CI, 0.85-1.29]; <i>P</i>=0.64). Major or nonmajor clinically relevant bleeding was reported in 146 patients (12.1%) in the genotype-guided cohort compared with 1384 patients (15.9%) in the standard care cohort (adjusted hazard ratio, 0.79 [95% CI, 0.67-0.94]; <i>P</i>=0.01). There was no significant association with net adverse cardiac events (adjusted hazard ratio, 0.91 [95% CI, 0.76-1.09]; <i>P</i>=0.31).</p><p><strong>Conclusions: </strong>In patients with acute coronary syndrome receiving antiplatelet therapy, implementation of a <i>CYP2C19</i> genotype-guided de-escalation strategy in clinical practice was associated with a significant reduction of major and nonmajor clinically relevant bleeding compared with standard care at 12 months, without increasing ischemic events.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT03823547.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e016084"},"PeriodicalIF":7.2,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147302789","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}