Background: Percutaneous left atrial appendage occlusion (LAAO) is an alternative to long-term anticoagulation for preventing ischemic stroke in patients with atrial fibrillation. There are limited long-term outcomes data for "real-world" patients undergoing LAAO.
Methods: We performed a retrospective cohort study using the National Cardiovascular Data Registry LAAO registry from January 1, 2016, through December 31, 2019.
Background: Mitral transcatheter edge-to-edge repair (MTEER) is approved for patients with secondary mitral regurgitation (SMR) and heart failure based on COAPT (The Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy) eligibility criteria. Outcomes in patients beyond COAPT criteria with more advanced heart disease remain unclear.
Objectives: This study aimed to assess the outcomes of MTEER in SMR patients beyond COAPT trial criteria from the global, post-market EXPANDed studies.
Background And Aims: The large-scale, randomized ILUMIEN IV trial was examined to determine whether procedural guidance with optical coherence tomography (OCT) during percutaneous coronary intervention (PCI) of angiographically calcified lesions improves outcomes.
Methods: Patients with a single PCI target lesion were included in the present analysis. The presence of none, mild, moderate or severe lesion calcification was determined by an angiographic core laboratory.
Background: 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.
Objectives: The aim of this study was to compare 1-year safety and clinical effectiveness of the Watchman FLX with the predicate Watchman 2.
Background: One-year outcomes of TRILUMINATE Pivotal (Trial to Evaluate Cardiovascular Outcomes in Patients Treated With the Tricuspid Valve Repair System Pivotal) found that transcatheter edge-to-edge repair (TEER) for the treatment of severe, symptomatic tricuspid regurgitation improved quality of life compared with medical therapy alone with similar rates of mortality and heart failure hospitalization. However, additional follow-up is necessary to determine the prolonged benefits of tricuspid TEER.
Methods: A total of 572 patients with severe, symptomatic tricuspid regurgitation were randomized to either tricuspid TEER+medical therapy (device group) or medical therapy alone (control).
JACC Cardiovasc Interv
April 2025
Background: Treating anterior and bileaflet mitral valve disease in patients with primary or degenerative mitral regurgitation (DMR) is considered more challenging than posterior leaflet repair.
Objectives: The aim of this analysis was to evaluate the impact of anterior, posterior, or bileaflet disease on outcomes following mitral transcatheter edge-to-edge repair (M-TEER) in the EXPANDed studies.
Methods: EXPANDed is a pooled, patient-level analysis of subjects undergoing M-TEER with the MitraClip G3 or G4 system as part of the contemporary EXPAND and EXPAND G4 studies.
JACC Clin Electrophysiol
May 2025
Background: Patients with tricuspid regurgitation (TR) frequently have transvalvular cardiac implantable electronic device (CIEDs).
Objectives: The aim of this study was to determine the safety and efficacy of tricuspid transcatheter edge-to-edge repair in patients with transvalvular CIED leads.
Methods: The TRILUMINATE (Trial to Evaluate Cardiovascular Outcomes in Patients Treated With the Tricuspid Valve Repair System) Pivotal Trial (NCT03904147) is an international randomized, controlled trial in symptomatic subjects with severe TR.
Ann Thorac Surg Short Rep
December 2024
Purpose: To report the outcomes of the early feasibility study of transapical transcatheter mitral valve replacement (TMVR) with the SATURN System (InnovHeart, Milano, Italy) to treat patients with severe functional mitral regurgitation.
Description: Five high surgical risk patients underwent transapical transcatheter mitral valve replacement with the SATURN System at a single center. One-year follow-up is complete for all patients.
JACC Cardiovasc Interv
December 2024
Background: Left atrial appendage occlusion (LAAO) is increasingly used as an alternative to oral anticoagulation for stroke prevention in select patients with atrial fibrillation. Data on outcomes in racial and ethnic minority individuals are limited. This analysis assessed differences in the use and outcomes of LAAO by race and ethnicity in a large national registry.
View Article and Find Full Text PDFJACC Cardiovasc Interv
December 2024
JACC Cardiovasc Interv
November 2024
Circulation
December 2024
J Am Coll Cardiol
September 2024
Background: The prevalence of and outcomes associated with different antithrombotic strategies after left atrial appendage occlusion (LAAO) are not well described.
Objectives: This study sought to evaluate patterns of antithrombotic medication strategies at discharge following LAAO with the Watchman FLX device in real-world practice and to compare the risk of adverse events among the different antithrombotic regimens.
Methods: The authors evaluated patients in the NCDR (National Cardiovascular Data Registry) LAAO Registry who underwent LAAO with the second-generation LAA closure device between 2020 and 2022.
Background And Aims: Observational registries have suggested that optical coherence tomography (OCT) imaging-derived parameters may predict adverse events after drug-eluting stent (DES) implantation. The present analysis sought to determine the OCT predictors of clinical outcomes from the large-scale ILUMIEN IV trial.
Methods: ILUMIEN IV was a prospective, single-blind trial of 2487 patients with diabetes or high-risk lesions randomized to OCT-guided versus angiography-guided DES implantation.
J Soc Cardiovasc Angiogr Interv
August 2023
J Soc Cardiovasc Angiogr Interv
November 2023
Circ Cardiovasc Interv
September 2024
Background: PINNACLE FLX (Protection Against Embolism for Nonvalvular AF Patients: Investigational Device Evaluation of the WATCHMAN FLX LAA Closure Technology) demonstrated improved outcomes and low incidence of adverse events with the WATCHMAN FLX device in a controlled setting. The National Cardiovascular Disease Registry's Left Atrial Appendage Occlusion Registry was utilized to assess the safety and effectiveness of WATCHMAN FLX in contemporary clinical practice in the United States.
Methods: The WATCHMAN FLX Device Surveillance Post Approval Analysis Plan used data from the Left Atrial Appendage Occlusion registry to identify patients undergoing WATCHMAN FLX implantation between August 2020 and September 2022.
Aims: A comparison of diagnostic performance comparing AI-QCT, coronary computed tomography angiography using fractional flow reserve (CT-FFR), and physician visual interpretation on the prediction of invasive adenosine FFR have not been evaluated. Furthermore, the coronary plaque characteristics impacting these tests have not been assessed.
Methods And Results: In a single centre, 43-month retrospective review of 442 patients referred for coronary computed tomography angiography and CT-FFR, 44 patients with CT-FFR had 54 vessels assessed using intracoronary adenosine FFR within 60 days.
Background: ILUMIEN IV was the first large-scale, multicenter, randomized trial comparing optical coherence tomography (OCT)-guided vs angiography-guided stent implantation in patients with high-risk clinical characteristics and/or complex angiographic lesions.
Objectives: The authors aimed to specifically examine outcomes in the complex angiographic lesions subgroup.
Methods: From the original trial population (N = 2,487), high-risk patients without complex angiographic lesions were excluded (n = 514).