Atsushi Sugiura MD, PhD , Julien Dreyfus MD, PhD , Sara Bombace MD , Maria Ivannikova MD , Joanna Bartkowiak MD , Stephan Haussig MD , Leonhard Moritz Schneider MD , Mohammad Kassar MD , Patrick Horn MD , Maurizio Taramasso MD , Christos Iliadis MD , Itsuki Osawa MD , Tadahiro Goto MD, MPH, PhD , Marcel Weber MD , Tetsu Tanaka MD , Sebastian Zimmer MD , Jean-François Obadia MD, PhD , Gilbert Habib MD , Baptiste Bazire MD , Bernard Iung MD , Georg Nickenig MD
{"title":"Transcatheter Edge-to-Edge Repair in Patients With Primary Tricuspid Regurgitation","authors":"Atsushi Sugiura MD, PhD , Julien Dreyfus MD, PhD , Sara Bombace MD , Maria Ivannikova MD , Joanna Bartkowiak MD , Stephan Haussig MD , Leonhard Moritz Schneider MD , Mohammad Kassar MD , Patrick Horn MD , Maurizio Taramasso MD , Christos Iliadis MD , Itsuki Osawa MD , Tadahiro Goto MD, MPH, PhD , Marcel Weber MD , Tetsu Tanaka MD , Sebastian Zimmer MD , Jean-François Obadia MD, PhD , Gilbert Habib MD , Baptiste Bazire MD , Bernard Iung MD , Georg Nickenig MD","doi":"10.1016/j.jcin.2025.03.023","DOIUrl":"10.1016/j.jcin.2025.03.023","url":null,"abstract":"<div><h3>Background</h3><div>Tricuspid regurgitation (TR) leads to right heart congestion and increased mortality risk. Unlike secondary TR, primary TR results from leaflet degeneration. Transcatheter edge-to-edge repair (TEER) is widely used for TR. However, its feasibility primary TR remains uncertain.</div></div><div><h3>Objectives</h3><div>The aim of this study was to assess the safety and feasibility of TEER in patients with primary TR.</div></div><div><h3>Methods</h3><div>The primary TR registry is a multicenter cohort study of patients with primary TR undergoing TEER. Echocardiographic assessment classified leaflet pathology into type 1 (flail), type 2 (billowing prolapse), type 3 (perforation), and type 4 (restricted mobility). The primary endpoint was TR reduction to moderate or less at discharge.</div></div><div><h3>Results</h3><div>From December 2016 to April 2023, 114 patients (mean age 79.9 years, 53.5% men) were included. Most patients were in NYHA functional class III or IV (83.3%), with a median TRI-SCORE of 5.0. The TR pathologies were type 1 (28.1%), type 2 (61.4%), and type 4 (10.5%), with no type 3 cases. Device deployment was achieved in 95.6%, and 83.3% showed TR reduction to moderate or less. In-hospital mortality was 1.8%, and single-leaflet device attachment occurred in 3.5%. At 1 year, 79.7% of patients had TR moderate or less, with significant reductions in vena contracta (−5.0 mm; <em>P</em> < 0.001), annular diameter (−2.0 mm; <em>P</em> = 0.003), and mid right ventricular diameter (−3.0 mm; <em>P</em> < 0.001). NYHA functional class also improved significantly (NYHA functional class I or II: 17.1% at baseline vs 66.5% at follow-up; <em>P</em> < 0.001).</div></div><div><h3>Conclusions</h3><div>TEER is a safe and effective option for primary TR, promoting right heart reverse remodeling and symptomatic relief, offering a vital alternative to surgery in selected patients.</div></div>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":"18 10","pages":"Pages 1289-1299"},"PeriodicalIF":11.7,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144139131","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}
Matthew J. Price MD , Zhen Tan , Sarah Zimmerman MS , Jeptha P. Curtis MD , James V. Freeman MD, MPH, MS
{"title":"Clinical Effectiveness of Transcatheter Left Atrial Appendage Occlusion With Watchman FLX Compared With First-Generation Watchman","authors":"Matthew J. Price MD , Zhen Tan , Sarah Zimmerman MS , Jeptha P. Curtis MD , James V. Freeman MD, MPH, MS","doi":"10.1016/j.jcin.2025.03.025","DOIUrl":"10.1016/j.jcin.2025.03.025","url":null,"abstract":"<div><h3>Background</h3><div>Procedural complications, device-related thrombus, and peridevice leak may limit the benefit of transcatheter left atrial appendage occlusion (LAAO). Although next-generation devices incorporate design modifications meant to address these phenomena, the longer term impact of these modifications on outcomes has not been described.</div></div><div><h3>Objectives</h3><div>The aim of this study was to compare 1-year safety and clinical effectiveness of the Watchman FLX with the predicate Watchman 2.5 device.</div></div><div><h3>Methods</h3><div>The National Cardiovascular Data Registry LAAO Registry was used to identify: 1) patients who received the Watchman FLX; and 2) an identical number of patients receiving the Watchman 2.5 at the same sites directly preceding the first Watchman FLX case at each site. The primary endpoint was ischemic stroke. A secondary analysis was performed using 2:1 propensity score matching.</div></div><div><h3>Results</h3><div>The study cohort consisted of 27,141 patients receiving each device. Among patients undergoing transesophageal echocardiography at 45 days, the rate of device-related thrombus was not different for Watchman FLX compared with Watchman 2.5 (0.4% vs 0.5%; <em>P</em> = 0.27) while the rate of any peridevice leak was significantly lower (14.7% vs 23.5%; <em>P</em> < 0.001). At 1 year, Watchman FLX was associated with a significantly lower risk for major adverse events (adjusted HR: 0.84; 95% CI: 0.80-0.88; <em>P</em> < 0.0001), ischemic stroke (adjusted HR: 0.82; 95% CI: 0.68-0.98; <em>P</em> = 0.02), and ischemic stroke or systemic embolism (adjusted HR: 0.74; 95% CI: 0.62-0.87; <em>P</em> = 0.0003). The findings of the propensity score matching analysis were similar.</div></div><div><h3>Conclusions</h3><div>Transcatheter LAAO with the Watchman FLX is associated with significantly lower risks for major adverse events and ischemic stroke at 1 year compared with the predicate Watchman device. These findings suggest that enhanced procedural safety and completeness of anatomical closure translate into better longer term safety and clinical effectiveness after transcatheter LAAO.</div></div>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":"18 10","pages":"Pages 1318-1326"},"PeriodicalIF":11.7,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144139134","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}
Mario Gaudino MD, PhD , Gregg W. Stone MD , Rachel S. Heise MS , Tulio Caldonazo MD , Jessica Kim MS , Lamia Harik MD , Sigrid Sandner MD , Giuseppe Biondi-Zoccai MD, PhD , Ruth Masterson-Creber PhD, MSc, RN , John H. Alexander MD, MHS , Deepak L. Bhatt MD, MPH, MBA , John Puskas MD , P.J. Devereaux MD, PhD , John Spertus MD, MPH , Bjorn Redfors MD, PhD
{"title":"Association Between Myocardial Infarction and Quality of Life in the ISCHEMIA Trial","authors":"Mario Gaudino MD, PhD , Gregg W. Stone MD , Rachel S. Heise MS , Tulio Caldonazo MD , Jessica Kim MS , Lamia Harik MD , Sigrid Sandner MD , Giuseppe Biondi-Zoccai MD, PhD , Ruth Masterson-Creber PhD, MSc, RN , John H. Alexander MD, MHS , Deepak L. Bhatt MD, MPH, MBA , John Puskas MD , P.J. Devereaux MD, PhD , John Spertus MD, MPH , Bjorn Redfors MD, PhD","doi":"10.1016/j.jcin.2025.02.011","DOIUrl":"10.1016/j.jcin.2025.02.011","url":null,"abstract":"<div><h3>Background</h3><div>The association between myocardial infarction (MI) subtypes (procedural MI [PMI] and spontaneous MI [SMI]) and subsequent quality of life (QoL) is incompletely understood.</div></div><div><h3>Objectives</h3><div>The authors analyzed the association between PMI and SMI and generic and disease-specific QoL in the ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) trial.</div></div><div><h3>Methods</h3><div>QoL was assessed before randomization and at 1.5, 3, and 6 months, and every 6 months thereafter. European Quality of Life-5 dimensions visual analog scale (EQ-5D VAS) (generic) and Seattle Angina Questionnaire (SAQ-7) summary score (disease-specific) were used. The primary analysis was a linear, repeated-measures, multivariable-adjusted, mixed-effects model, with a random intercept for patient. QoL assessments occurring <3 months after MI were defined as early QoL and those occurring >3 months after MI were defined as late QoL.</div></div><div><h3>Results</h3><div>A total of 4,375 randomized patients were included in the primary analysis population. The median duration of follow-up was 36.2 months (Q1-Q3: 23.8-49.5 months). In the primary analysis population, a total of 84 PMIs and 352 SMIs occurred. SMI was associated with significant decreases in both early (adjusted difference −5.7; 95% CI: −7.3 to −4.1 points) and late EQ-5D VAS (−3.1 points; 95% CI: −4.3 to −1.9 points) and in early (−7.7 points; 95% CI: −9.4 to −6.1 points) and late SAQ-7 (−1.9 points; 95% CI: −3.2 to −0.7 points). PMI was not associated with early (adjusted difference −0.8 points; 95% CI: −3.3 to 1.8 points) or late (−0.7 points; 95% CI: −2.7 to 1.2 points) changes in EQ-5D VAS, and was associated with a reduction in early (−3.0 points; 95% CI: −5.7 to −0.4) but not late SAQ-7 (−0.2 points; 95% CI −2.2 to 1.8 points).</div></div><div><h3>Conclusions</h3><div>In ISCHEMIA, SMI was associated with reductions in both early and late generic and disease-specific QoL, whereas PMI was only associated with a transient reduction in disease-specific QoL.</div></div>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":"18 10","pages":"Pages 1263-1272"},"PeriodicalIF":11.7,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143991048","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":"Opening the Door (A Bit More) to PFO Closure in Older Patients","authors":"Steven R. Messé MD , Paul N. Fiorilli MD","doi":"10.1016/j.jcin.2025.04.007","DOIUrl":"10.1016/j.jcin.2025.04.007","url":null,"abstract":"","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":"18 10","pages":"Pages 1315-1317"},"PeriodicalIF":11.7,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144137926","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}
Ruby Satpathy MD , Josep Rodés-Cabau MD, PhD , David E. Thaler MD, PhD , David M. Kent MD, MS , Samuel Turner MD , Srinivasa Potluri MD , Kranthi K. Kolli PhD , Nils Peter Borgstrom PhD , Julie B. Prillinger PhD , Jeffrey L. Saver MD
{"title":"PFO Device Closure in Patients >60 Years of Age With Ischemic Stroke","authors":"Ruby Satpathy MD , Josep Rodés-Cabau MD, PhD , David E. Thaler MD, PhD , David M. Kent MD, MS , Samuel Turner MD , Srinivasa Potluri MD , Kranthi K. Kolli PhD , Nils Peter Borgstrom PhD , Julie B. Prillinger PhD , Jeffrey L. Saver MD","doi":"10.1016/j.jcin.2025.03.034","DOIUrl":"10.1016/j.jcin.2025.03.034","url":null,"abstract":"<div><h3>Background</h3><div>Transcatheter closure of patent foramen ovale (PFO) is a recommended stroke reduction option in patients ≤60 years of age with cryptogenic ischemic stroke, but data on clinical outcomes following PFO closure in patients >60 years of age are scarce.</div></div><div><h3>Objectives</h3><div>The aim of this real-world evidence study was to evaluate the clinical outcomes of PFO closure in patients >60 years of age in the United States.</div></div><div><h3>Methods</h3><div>Medicare fee-for-service data from 2016 to 2022 were used to identify patients >60 years of age who were hospitalized with ischemic stroke and diagnosed with PFO or atrial septal defect and also had ≥6 months of prior fee-for-service coverage. Patients who were implanted with the Amplatzer or Talisman PFO occluder (device group) were identified by linkage to a manufacturer device-tracking database and were propensity score matched (1:4) to those who did not undergo device implantation (control group). Acute safety events through 30 days and recurrent ischemic stroke through 3 years were evaluated.</div></div><div><h3>Results</h3><div>A total of 20,999 Medicare beneficiaries (device group, n = 1,132; control group, n = 19,867) met the inclusion criteria. The matched cohort included 5,508 Medicare beneficiaries (device group, n = 1,132; control group, n = 4,376), with 45% women, a median age of 71 years (Q1-Q3: 67-75 years), and median follow-up of 2.58 years (Q1-Q3: 1.17-3.97 years). The risk for recurrent ischemic stroke was significantly lower in the device group (1.65 [95% CI: 1.18-2.13] events per 100 patient-years) than the control group (2.66 [95% CI: 2.33-3.00] events per 100 patient-years) (HR: 0.62; 95% CI: 0.44-0.88; <em>P</em> = 0.007). Rates of 30-day safety events were not different for death, but venous thromboembolism (1.86% vs 0.37%; <em>P</em> < 0.001) and atrial fibrillation or flutter (1.41% vs 0.64%; <em>P</em> = 0.01) were more common in the device group.</div></div><div><h3>Conclusions</h3><div>In a real-world U.S. cohort of patients >60 years of age, PFO closure was associated with a reduced risk for recurrent ischemic stroke compared with medical therapy alone, while maintaining a clinically acceptable safety profile.</div></div>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":"18 10","pages":"Pages 1303-1314"},"PeriodicalIF":11.7,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144139133","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}