Percutaneous MitraClip Device or Surgical Mitral Valve Repair in Patients With Primary Mitral Regurgitation Who Are Candidates for Surgery: Design and Rationale of the REPAIR MR Trial.

Background The current standard of care for the treatment of patients with primary mitral regurgitation (MR) is surgical mitral valve repair. Transcatheter edge-to-edge repair with the MitraClip device provides a less invasive treatment option for patients with both primary and secondary MR. Worldwide, >150 000 patients have been treated with the MitraClip device.

Bioprosthetic Aortic Valve Hemodynamics: Definitions, Outcomes, and Evidence Gaps: JACC State-of-the-Art Review.

A virtual workshop was organized by the Heart Valve Collaboratory to identify areas of expert consensus, areas of disagreement, and evidence gaps related to bioprosthetic aortic valve hemodynamics. Impaired functional performance of bioprosthetic aortic valve replacement is associated with adverse patient outcomes; however, this assessment is complicated by the lack of standardization for labelling, definitions, and measurement techniques, both after surgical and transcatheter valve replacement. Echocardiography remains the standard assessment methodology because of its ease of performance, widespread availability, ability to do serial measurements over time, and correlation with outcomes.

Hot topics in interventional cardiology: Proceedings from the society for cardiovascular angiography and interventions (SCAI) 2021 think tank.

The Society for Cardiovascular Angiography and Interventions (SCAI) Think Tank is a collaborative venture that brings together interventional cardiologists, administrative partners, and select members of the cardiovascular industry community annually for high-level field-wide discussions. The 2021 Think Tank was organized into four parallel sessions reflective of the field of interventional cardiology: (a) coronary intervention, (b) endovascular medicine, (c) structural heart disease, and (d) congenital heart disease. Each session was moderated by a senior content expert and co-moderated by a member of SCAI's Emerging Leader Mentorship program.

Impact of the COVID-19 pandemic: a perspective from industry.

The global COVID-19 pandemic has led to unprecedented change throughout society. As the articles in this supplement outline, all segments of the broader cardiovascular community have been forced to adapt, to change models of care delivery, and to evolve and innovate in order to deliver optimal management for cardiovascular patients. The medtech/device industry has not been exempt from such change and has been forced to navigate direct and indirect COVID-associated disruption, with effects felt from supply chain logistics to the entire product lifecycle, from the running of clinical trials to new device approvals and managing training, proctoring and congresses in an increasingly-online world.

Association of Radial Artery Graft vs Saphenous Vein Graft With Long-term Cardiovascular Outcomes Among Patients Undergoing Coronary Artery Bypass Grafting: A Systematic Review and Meta-analysis.

Importance: Observational studies have suggested that the use of radial artery grafts for coronary artery bypass grafting may improve clinical outcomes compared with the use of saphenous vein grafts, but this has not been confirmed in randomized trials.

Objective: To compare clinical outcomes between patients receiving radial artery vs saphenous vein grafts for coronary artery bypass grafting after long-term follow-up.

Design, Setting, And Participants: Patient-level pooled analysis comparing radial artery vs saphenous vein graft in adult patients undergoing isolated coronary artery bypass grafting from 5 countries (Australia, Italy, Serbia, South Korea, and the United Kingdom), with enrollment from 1997 to 2009 and follow-up completed in 2019.

The RADial artery International ALliance (RADIAL) extended follow-up study: rationale and study protocol.

It is generally accepted that radial artery (RA) grafts have better mid-term patency rate compared to saphenous vein grafts. However, the clinical correlates of the improved patency rate are still debated. Observational studies have suggested increased survival and event-free survival for patients who receive an RA rather than a saphenous vein, but they are open to bias and confounders.

Angiographic Outcome of Coronary Artery Bypass Grafts: The Radial Artery Database International Alliance.

Background: We used a large patient-level data set including 6 angiographic randomized controlled trials (RCTs) on coronary artery bypass conduits to explore incidence and determinants of coronary graft failure.

Methods: Patient-level angiographic data of 6 RCTs comparing long-term outcomes of the radial artery and other conduits were joined. Primary outcome was graft occlusion at maximum follow-up.

Outcomes Following Transcatheter Aortic Valve Replacement for Degenerative Stentless Versus Stented Bioprostheses.

Objectives: A large comprehensive analysis of transcatheter aortic valve replacement (TAVR) was performed for failed stentless bioprostheses.

Background: Valve-in-valve (ViV) transcatheter aortic replacement (TAVR) is an alternative to redo surgery for patients with a failing aortic bioprosthesis.

Methods: Unadjusted outcome data were collected from the VIVID (Valve-in-Valve International Data) registry between 2007 and 2016 from a total of 1,598 aortic ViV procedures (291 stentless, 1,307 stented bioprostheses).

Effect of Calcium-Channel Blocker Therapy on Radial Artery Grafts After Coronary Bypass Surgery.

Background: Few studies have evaluated the effect of chronic calcium-channel blocker therapy (CCB) on the angiographic and clinical outcome of radial artery (RA) grafts used for coronary bypass surgery.

Objectives: The purpose of this study was to evaluate if CCB influences midterm clinical and angiographic outcomes of RA grafts.

Methods: Patient-level data of 6 angiographic randomized trials evaluating RA graft status at midterm follow-up were joined in this observational analysis.

Initial Feasibility Study of a New Transcatheter Mitral Prosthesis: The First 100 Patients.

Background: Transcatheter mitral valve replacement (TMVR) is a rapidly evolving therapy. Follow-up of TMVR patients remains limited in duration and number treated.

Objectives: The purpose of this study was to examine outcomes with expanded follow-up for the first 100 patients who underwent TMVR with the prosthesis.

Harpoon Repair for Mitral Regurgitation: A Case Report.

• Primary mitral regurgitation (MR) is commonly due to mitral valve (MV) prolapse. • Off-pump minimally invasive MV repair is an alternative to conventional MV surgery. • This case describes MV repair using the Harpoon TSD-5 device.

Cardiac rehabilitation to improve health-related quality of life following trans-catheter aortic valve implantation: a randomised controlled feasibility study: RECOVER-TAVI Pilot, ORCA 4, For the Optimal Restoration of Cardiac Activity Group.

Objectives: Transcatheter aortic valve implantation (TAVI) is often undertaken in the oldest frailest cohort of patients undergoing cardiac interventions. We plan to investigate the potential benefit of cardiac rehabilitation (CR) in this vulnerable population.

Design: We undertook a pilot randomised trial of CR following TAVI to inform the feasibility and design of a future randomised clinical trial (RCT).

Transcatheter Aortic Valve Replacement to Treat Liver Decompensation.

•Critical aortic stenosis can cause severe biventricular disease.•Painless jaundice can present secondary to severe biventricular failure.•TAVR treats high-risk critical aortic stenosis.

Radial-Artery or Saphenous-Vein Grafts in Coronary-Artery Bypass Surgery.

Background: The use of radial-artery grafts for coronary-artery bypass grafting (CABG) may result in better postoperative outcomes than the use of saphenous-vein grafts. However, randomized, controlled trials comparing radial-artery grafts and saphenous-vein grafts have been individually underpowered to detect differences in clinical outcomes. We performed a patient-level combined analysis of randomized, controlled trials to compare radial-artery grafts and saphenous-vein grafts for CABG.

'Porcelain aorta': a proposed definition and classification of ascending aortic calcification.

Introduction: 'Porcelain aorta' is listed in the second consensus document of the Valve Academic Research Consortium as a risk factor in aortic valve replacement. However, the extent of circumferential involvement is poorly defined with great variability in reported incidence. We present a simple, reproducible classification to describe the extent of aortic calcification and thus appropriately define 'porcelain aorta', aiding clinical decision-making and registry data collection.

Standardized Definition of Structural Valve Degeneration for Surgical and Transcatheter Bioprosthetic Aortic Valves.

Bioprostheses are prone to structural valve degeneration, resulting in limited long-term durability. A significant challenge when comparing the durability of different types of bioprostheses is the lack of a standardized terminology for the definition of a degenerated valve. This issue becomes especially important when we try to compare the degeneration rate of surgically inserted and transcatheter bioprosthetic valves.

Impact of Pre-Existing Prosthesis-Patient Mismatch on Survival Following Aortic Valve-in-Valve Procedures.

Objectives: The aim of this study was to determine whether the association of small label size of the surgical valve with increased mortality after transcatheter valve-in-valve (ViV) implantation is, at least in part, related to pre-existing prosthesis-patient mismatch (PPM) (i.e., a bioprosthesis that is too small in relation to body size).

Novel United Kingdom prognostic model for 30-day mortality following transcatheter aortic valve implantation.

Objective: Existing clinical prediction models (CPM) for short-term mortality after transcatheter aortic valve implantation (TAVI) have limited applicability in the UK due to moderate predictive performance and inconsistent recording practices across registries. The aim of this study was to derive a UK-TAVI CPM to predict 30-day mortality risk for benchmarking purposes.

Methods: A two-step modelling strategy was undertaken: first, data from the UK-TAVI Registry between 2009 and 2014 were used to develop a multivariable logistic regression CPM using backwards stepwise regression.

Anatomy of the Tricuspid Valve, Pathophysiology of Functional Tricuspid Regurgitation, and Implications for Percutaneous Therapies.

The tricuspid valve is a complex dynamic apparatus made up of many different closely linked structures: the annulus, the three leaflets, the chordae, the papillary muscles and the right ventricle. Other nearby structures, such as the coronary sinus ostium, the conduction system, the membranous septum, and the right coronary artery must be taken into account when dealing with the tricuspid. Annulus dilation and leaflet tethering due to right ventricular remodeling are the 2 major mechanisms responsible for most tricuspid regurgitation cases.

Beating-Heart Mitral Valve Repair Using a Novel ePTFE Cordal Implantation Device: A Prospective Trial.

Background: Conventional mitral valve (MV) operations allow direct anatomic assessment and repair on an arrested heart, but require cardiopulmonary bypass, aortic cross-clamping, sternotomy or thoracotomy, and cardioplegic cardiac arrest, and are associated with significant perioperative disability, and risks of morbidity and mortality.

Objectives: This study evaluated safety and performance of a transesophageal echocardiographic-guided device designed to implant artificial expanded polytetrafluoroethylene (ePTFE) cords on mitral leaflets in the beating heart.

Methods: In a prospective multicenter study, 30 consecutive patients with severe degenerative mitral regurgitation (MR) were treated with a mitral valve repair system (MVRS) via small left thoracotomy.

Relative Survival After Transcatheter Aortic Valve Implantation: How Do Patients Undergoing Transcatheter Aortic Valve Implantation Fare Relative to the General Population?

Background: Transcatheter aortic valve implantation (TAVI) is indicated for patients with aortic stenosis who are intermediate-high surgical risk. Although all-cause mortality rates after TAVI are established, survival attributable to the procedure is unclear because of competing causes of mortality. The aim was to report relative survival (RS) after TAVI, which accounts for background mortality risks in a matched general population.

Repair of Tricuspid Valve Leaflet With CardioCel Patch After Traumatic Tricuspid Regurgitation.

Posttraumatic tricuspid valve regurgitation (TR) is a rare entity and is almost always associated with blunt chest trauma. It is usually identified by transthoracic echocardiography after the manifestation of clinical symptoms of heart failure. Treatment varies from long-term medical therapy and observation to surgical correction with tricuspid valve replacement or repair.

Transcatheter mitral valve replacement: long-term outcomes of first-in-man experience with an apically tethered device- a case series from a single centre.

Aims: Transcatheter mitral valve replacement (TMVR) is a novel technique for treating mitral regurgitation. We report 18-month/two-year outcomes of the five first-in-man patients undergoing chronic TMVR with the Tendyne device.

Methods And Results: Five patients (STS score range 14%-23%) underwent TMVR using the Tendyne system under compassionate use at a single centre.