Tricuspid valve replacement outcomes by baseline tricuspid regurgitation severity: the TRISCEND II trial.

Background And Aims: The TRISCEND II trial demonstrated superior clinical benefits for patients with ≥severe tricuspid regurgitation (TR) treated with the EVOQUE transcatheter tricuspid valve replacement (TTVR) system plus medical therapy versus medical therapy alone. This work reports 1-year and 18-month outcomes in patients stratified by baseline TR severity.

Methods: The multicentre, prospective TRISCEND II trial enrolled 400 patients with symptomatic, ≥severe TR and randomised 2:1 to TTVR (n=267) or control (n=133).

Echocardiographic Imaging Considerations for Post-Implant Evaluation of the Transcatheter EVOQUE Tricuspid Valve Replacement System.

The transcatheter EVOQUE tricuspid valve replacement system is an approved device for the treatment of patients with symptomatic severe tricuspid regurgitation despite medical therapy both in the United States and in Europe. Specific imaging requirements are needed in the screening and in the intraprocedural phase as well as to assess this valve after implantation, in order to assess its positioning and performance. In this review, focus will be on the postoperative echocardiographic assessment of device positioning and stability; evaluation of residual central tricuspid regurgitation or paravalvular leak; valve thrombosis/degeneration; interaction of the device frame with the right ventricle and adjacent structures, including the aortic valve and interventricular septum; and placement of pacemaker leads.

Transcatheter Edge-to-Edge Repair in Secondary Mitral Regurgitation With Extended Non-COAPT-Like Features: From the EXPANDed Studies.

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.

One- versus three-month DAPT after everolimus-eluting stent implantation in diabetic patients at high bleeding risk: results from the XIENCE Short DAPT programme.

Background: In patients with diabetes mellitus (DM) and high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI), the optimal duration of dual antiplatelet therapy (DAPT) remains uncertain.

Aims: We sought to compare early DAPT discontinuation in DM and non-DM patients enrolled in the prospective XIENCE Short DAPT programme.

Methods: The effects of 1- versus 3-month DAPT on ischaemic and bleeding outcomes were compared using propensity score stratification.

Safety and Efficacy of Cobalt Chromium Everolimus-Eluting Stents for Treatment of In-Stent Restenosis: An ILUMIEN IV Substudy.

Background: The optimal management strategy for in-stent restenosis (ISR) remains unclear. We aimed to determine the safety and efficacy of percutaneous coronary intervention with XIENCE cobalt chromium everolimus-eluting stents (EES) for treatment of ISR.

Methods: In the ILUMIEN IV (Optical Coherence Tomography Guided Coronary Stent Implantation Compared to Angiography: A Multicenter Randomized Trial in Percutaneous Coronary Intervention) trial, the 1-year outcomes of all randomized patients with a single diffuse or multifocal single-layer ISR lesion treated with EES were compared with a performance goal.

1-Month or 3-Month DAPT in Women and Men at High Bleeding Risk Undergoing PCI.

Background: In patients at high bleeding risk (HBR), short dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) is associated with reduced bleeding and preserved ischemic protection.

Objectives: The aim of this study was to compare 2 short DAPT regimens, followed by aspirin monotherapy, in women and men at HBR undergoing PCI.

Methods: Data from 3 prospective, international studies (XIENCE Short DAPT Program) including patients at HBR undergoing PCI with fluoropolymer-based cobalt-chromium everolimus-eluting stents (XIENCE) were analyzed.

ISR vs De Novo Lesion Treatment During OCT-Guided PCI: Insights From the LightLab Initiative.

Background: Long-term outcomes after percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) are poor, yet limited granular procedural data exist evaluating lesion assessment, vessel treatment, and acute procedural outcomes.

Methods: The LightLab Initiative was a multicenter, prospective, observational study with contemporaneous procedural data collection during PCI procedures. Data were collected during PCIs performed by 48 interventional cardiologists at 17 US hospitals (2019-2021).

1-Year Outcomes With Fourth-Generation Mitral Valve Transcatheter Edge-to-Edge Repair From the EXPAND G4 Study.

Background: The fourth-generation mitral transcatheter edge-to-edge repair (M-TEER) device introduced an improved clip deployment sequence, independent leaflet grasping, and 2 wider clip sizes to tailor the treatment of patients with mitral regurgitation (MR) for a broad range of anatomies. The 30-day safety and effectiveness of the fourth-generation M-TEER device were previously demonstrated.

Objectives: The aim of this study was to evaluate 1-year outcomes in a contemporary, real-world cohort of subjects treated with the MitraClip G4 system.

Transfemoral Transcatheter Mitral Valve Implantation With a Dedicated Device in a Rheumatic Mitral Stenosis Patient.

A 65-year-old obese woman with rheumatic heart disease and restrictive lung disease presented with decompensated heart failure. Evaluation demonstrated severely thickened mitral valve leaflets, severe mitral stenosis, and moderate mitral regurgitation. She underwent successful transfemoral transseptal transcatheter mitral valve replacement with a dedicated valve resulting in improved functional status.

Expanding the Spectrum of TEER Suitability: Evidence From the EXPAND G4 Post Approval Study.

Background: Anatomical and clinical criteria to define mitral transcatheter edge-to-edge repair (TEER) "unsuitability" have been proposed on the basis of a Heart Valve Collaboratory consensus opinion from physician experience with early-generation TEER devices but lacked an evidence-based approach.

Objectives: The aim of this study was to explore the spectrum of TEER suitability using echocardiographic and clinical outcomes from the EXPAND G4 real-world postapproval study.

Methods: EXPAND G4 is a global, prospective, multicenter, single-arm study that enrolled 1,164 subjects with mitral regurgitation (MR) treated with the MitraClip G4 System.

Real-World Outcomes of Fourth-Generation Mitral Transcatheter Repair: 30-Day Results From EXPAND G4.

Background: The fourth-generation MitraClip G4 System builds on the previous NTR/XTR system with additional wider clip sizes (NTW and XTW), an independent grasping feature, and an improved clip deployment sequence.

Objectives: The primary objective of this study was to assess the safety and performance of the MitraClip G4 System within a contemporary real-world setting.

Methods: EXPAND G4 is a prospective, multicenter, international, single-arm, postapproval study that enrolled patients with primary (degenerative) mitral regurgitation (MR) and secondary (functional) MR at 60 centers.

One-year Outcomes of XIENCE Skypoint 48-mm Drug-Eluting Stents in Long Coronary Lesions: The SPIRIT 48 Trial.

Background: Diffuse coronary artery disease may need multiple overlapping stents, associated with less favorable outcomes than those of a single stent. The availability of longer stents can circumvent the need for overlapping stents in long lesions. This prospective, single-arm, SPIRIT 48 trial evaluated the safety and effectiveness of Abbott's next-generation drug-eluting stent, XIENCE Skypoint 48, in patients with coronary artery disease with long de novo native coronary lesions.

30-Day Clinical Outcomes of a Self-Expanding Transcatheter Aortic Valve: The International PORTICO NG Study.

Background: The self-expanding, intra-annular Navitor (Abbott Structural Heart) valve includes an outer cuff to reduce paravalvular leak (PVL) and large stent cells for future coronary access.

Objectives: The purpose of the PORTICO NG (Evaluation of the Portico NG [Next Generation] Transcatheter Aortic Valve in High and Extreme Risk Patients With Symptomatic Severe Aortic Stenosis) study is to evaluate the safety and effectiveness of the Navitor valve in patients with symptomatic, severe aortic stenosis who are at high or extreme surgical risk.

Methods: PORTICO NG is a prospective, multicenter, global study with follow-up at 30 days, 1 year, and annually through 5 years.

Contemporary Outcomes Following Transcatheter Edge-to-Edge Repair: 1-Year Results From the EXPAND Study.

Background: The third-generation MitraClip NTR/XTR transcatheter edge-to-edge repair system was introduced to assist in leaflet grasping with the longer clip arms of MitraClip XTR and to improve ease of use with the modified delivery catheter.

Objectives: The EXPAND study evaluated contemporary real-world outcomes in subjects with mitral regurgitation (MR) treated with the third-generation MitraClip NTR/XTR transcatheter edge-to-edge repair system.

Methods: EXPAND is a prospective, multicenter, international, single-arm study that enrolled patients with primary MR and secondary MR at 57 centers.

Thirty-day and one-year outcomes of the Navitor transcatheter heart valve in patients with aortic stenosis: the prospective, multicentre, global PORTICO NG Study.

Background: The Navitor transcatheter heart valve (THV) is a self-expanding valve, with an intra-annular leaflet position and an outer cuff intended to reduce paravalvular leak (PVL).

Aims: The aim of the PORTICO NG Study is to assess the safety and performance of the Navitor THV in patients with symptomatic, severe aortic stenosis who are at high or extreme surgical risk.

Methods: PORTICO NG is a prospective, multicentre, global, single-arm, investigational study with follow-up at 30 days, 1 year, and annually up to 5 years.

The MLD MAX OCT algorithm: An imaging-based workflow for percutaneous coronary intervention.

Although extensive clinical data support the utility of intravascular imaging to guide and optimize outcomes following percutaneous coronary interventions (PCI), clinical adoption remains limited. One of the primary reasons for limited utilization may be a lack of standardization on how to best integrate the data provided by intravascular imaging practically. Optical coherence tomography (OCT) offers a high-resolution intravascular imaging modality with integrated software automation that allows for incorporation of OCT into the routine workflow of PCIs.

Improving efficiency and operator proficiency during percutaneous coronary interventions utilizing a standardized optical coherence tomography workflow.

Objectives: This study was designed to compare efficiency and quality metrics between percutaneous coronary intervention (PCI) procedures using optical coherence tomography (OCT) guided by a variable workflow versus a standardized workflow in a real-world population.

Background: The LightLab (LL) Initiative was designed to evaluate the impact of a standardized OCT workflow during PCI to address barriers to adoption.

Methods: The LL Initiative was a multicenter, prospective, observational study.

One-Year Results of the Portico Transcatheter Aortic Heart Valve Using the Next-Generation FlexNav Delivery System.

Background: The FlexNav delivery system (DS) features a hydrophilic coating, stability layer, and integrated sheath to facilitate valve deployment in vessel diameters ≥5.0 mm.

Methods: Data were pooled from 2 concurrent prospective, multicenter, premarket studies (PORTICO IDE [n = 147] and FlexNav EU CE Mark [n = 46]) to evaluate the safety and efficacy of the FlexNav DS to deliver the Portico valve in the Global FlexNav study.

Early outcomes of transcatheter mitral valve replacement with the Tendyne system in severe mitral annular calcification.

Background: Treatment of mitral regurgitation (MR) associated with severe mitral annular calcification (MAC) is challenging due to the high risk of fatal atrioventricular groove disruption and significant paravalvular leak.

Aims: The aim of this study was to evaluate the outcomes of transcatheter mitral valve replacement (TMVR) with the Tendyne valve (Abbott Structural) in patients with MR and MAC.

Methods: Twenty patients (mean age 78 years; 11 women) who were treated with the Tendyne valve, either compassionate use (CU; closed) or as part of The Feasibility Study of Tendyne in MAC (NCT03539458), had reported outcomes in a median follow-up duration of 368 days.

Duration of Dual Antiplatelet Therapy for Patients at High Bleeding Risk Undergoing PCI.

Background: The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) among patients at high bleeding risk (HBR) is unknown.

Objectives: The purpose of this analysis was to compare 1 vs 3 months of DAPT in HBR patients undergoing drug-eluting stent implantation.

Methods: The XIENCE Short DAPT program comprised 3 prospective, multicenter, single-arm studies of HBR patients treated with a short DAPT course followed by aspirin monotherapy after PCI with a cobalt-chromium everolimus-eluting stent.