Severe mitral annular calcification (MAC) presents a critical challenge in mitral valve surgery, particularly in elderly and frail patients. Kulshrestha and Kaneko describe a hybrid approach combining conventional surgical principles with transcatheter intervention in an 82-year-old patient with calcific mitral stenosis and extensive MAC. Their technique involves direct surgical exposure, selective anterior leaflet resection to prevent left ventricular outflow tract obstruction, limited annular debridement, and deployment of a SAPIEN 3 Ultra valve under direct visualization via median sternotomy. A notable innovation includes a customized bovine pericardial skirt attached to the prosthetic frame to improve annular sealing and reduce paravalvular leak, a common complication in valve-in-MAC procedures. The approach represents an off-label application requiring comprehensive multidisciplinary planning with cardiac surgery, structural intervention, and imaging expertise. Cardiac-gated computed tomography guides prosthesis sizing and calcium assessment. This hybrid strategy preserves the calcified annulus as a rigid scaffold while minimizing risks from extensive calcium removal, offering improved outcomes for this high-risk patient population previously considered inoperable.

Transcatheter mitral valve replacement (TMVR) represents a minimally invasive alternative to open-heart surgery for patients with severe mitral regurgitation or stenosis who are unsuitable for surgical intervention or repair with devices like MitraClip or Pascal. Unlike the aortic valve, the mitral valve's complex saddle-shaped, non-calcified annulus presents unique anchoring challenges, necessitating diverse transcatheter strategies. The SAPIEN M3 (Edwards Lifesciences) is a dedicated system designed for native mitral disease, employing a "dock-then-valve" two-step approach to create its own anchoring mechanism. Additionally, TMVR addresses patients with failed previous surgical repairs through valve-in-ring procedures, where transcatheter valves deploy within existing annuloplasty rings, and valve-in-valve techniques for degenerated tissue bioprostheses. The latter approach, utilizing the metal frame of surgical valves as a landing zone, has become established routine care. All patients undergo multidisciplinary structural valve team review before procedure consideration, ensuring individualized suitability assessment through imaging protocols. This expanding TMVR armamentarium offers high-risk patients viable alternatives to redo surgery.

UCSF is currently conducting multiple advanced clinical trials investigating transcatheter and surgical approaches to treat mitral valve insufficiency, enrolling eligible patients aged 18 and older across San Francisco and other locations. These ongoing trials evaluate several innovative technologies including the CMCS device for functional mitral regurgitation, the HARPOON System for severe degenerative mitral regurgitation, the Edwards PASCAL Transcatheter Valve Repair System for both degenerative and functional regurgitation in high-risk patients, and the MitraClip device compared against surgical repair in moderate-risk patients. Additional trials include a multicenter randomized study comparing transcatheter edge-to-edge repair across multiple TEER-approved devices to surgical repair in patients with primary degenerative mitral regurgitation, and investigations into severe mitral annular calcification treatment. These trials employ rigorous methodologies including double-blinded, sham-controlled designs and randomized controlled comparisons to establish safety and effectiveness. Currently, all trials listed are in progress and not accepting new patients, reflecting the substantial clinical activity in developing less invasive alternatives to traditional mitral valve surgery while improving outcomes for patients with various forms of mitral insufficiency across diverse risk profiles.

« Ces fonds permettront d’accélérer le déploiement commercial de HighLife en Europe et de poursuivre son programme de développement clinique aux États-Unis », précise dans un communiqué la start-up fondée en 2010. La levée de fonds a été pilotée conjointement par Sofinnova Partners, Andera Partners, Supernova Invest et Mérieux Equity Partners. D’autres investisseurs y ont participé. En janvier, la société implantée à Paris a obtenu le marquage CE pour son système de remplacement transcathéter de la valve mitrale (TMVR), permettant « un lancement commercial ciblé en Europe ».

The FDA maintains authority to mandate post-approval studies (PAS) for medical devices approved through premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) pathways. These studies serve a critical function in generating ongoing safety and effectiveness data for approved medical devices throughout their commercial lifecycle. The agency's Post-Approval Studies Database enables stakeholders—including patients, healthcare professionals, device manufacturers, and regulatory bodies—to access and search comprehensive information about these studies by applicant or device specifications. By facilitating transparency and data accessibility, this database supports continued monitoring of device performance in real-world settings, helping ensure sustained patient safety while providing industry with evidence of long-term clinical benefits. This initiative represents the FDA's commitment to post-market surveillance and evidence-based device regulation beyond the initial approval phase.

This document provides a comprehensive overview of transcatheter procedures for treating heart valve conditions, specifically designed for Kentucky healthcare providers and patients. Transcatheter approaches represent a significant advancement in interventional cardiology, offering minimally invasive alternatives to traditional open-heart surgery for patients with valve disease. These catheter-based techniques allow physicians to repair or replace damaged heart valves through small incisions, reducing recovery time and procedural risks compared to conventional surgical interventions. The document outlines various transcatheter valve procedures, including aortic valve replacement and mitral valve repair, detailing their mechanisms, clinical applications, and patient selection criteria. It addresses the growing importance of these technologies in managing valve conditions across diverse patient populations, particularly those at high surgical risk. By presenting evidence-based information on procedure efficacy, safety profiles, and appropriate indications, this resource aims to enhance awareness and understanding among healthcare professionals and patients in Kentucky, ultimately improving access to advanced cardiac care and treatment outcomes for individuals suffering from valvular heart disease.

Transcatheter mitral edge-to-edge repair has revolutionized treatment for high-risk patients with primary mitral regurgitation, yet long-term outcomes remain highly variable. While previous research focused primarily on left ventricular geometry and mitral anatomy, emerging evidence demonstrates that right-sided heart pathology significantly influences post-procedural outcomes. Concomitant tricuspid regurgitation frequently develops secondary to mitral dysfunction through shared hemodynamic pathways, as left atrial volume overload increases pulmonary venous pressure and strains the right ventricle. Even after successful mitral clipping, residual tricuspid regurgitation can cause persistent heart failure symptoms, yet it remains unclear whether severe tricuspid disease resolves independently or requires separate intervention. To clarify these prognostic relationships, researchers analyzed the PRIME-MR registry, a large multicenter international study comprising 3,083 patients with severe degenerative mitral disease who underwent edge-to-edge repair between 2008 and 2022 at twenty-five specialized academic centers across North America and Europe. Among 2,155 patients achieving procedural success, eighty percent had moderate or less tricuspid regurgitation while twenty percent presented with severe regurgitation. Understanding baseline right-sided valve disease severity is essential for comprehensive risk stratification and tailoring treatment strategies to improve survival after transcatheter mitral repair.

Transcatheter edge-to-edge repair (TEER) offers a minimally invasive alternative to open-heart surgery for patients with leaking mitral or tricuspid valves. The procedure involves deploying a small clip—MitraClip, PASCAL, or TriClip for the tricuspid valve—through the groin via catheter to secure valve leaflet edges and restore proper closure. Performed under general anaesthetic in the cardiac catheterisation laboratory with transoesophageal echocardiography and X-ray guidance, TEER typically takes one to two hours, allowing most patients to return home within one or two nights. At Central Sydney Cardiology, Associate Professor Jordan Fulcher evaluates candidates and performs TEER procedures at Royal Prince Alfred Hospital. The technique addresses both primary regurgitation, where valve damage causes leakage, and secondary regurgitation from enlarged heart chambers. With over 200,000 patients treated worldwide since the first procedure in 2003, TEER has become an established treatment for valve disease causing breathlessness, fatigue, and fluid retention while significantly improving patient outcomes and quality of life.

For patients with severe degenerative mitral regurgitation (DMR) at prohibitive or high surgical risk, transcatheter edge-to-edge repair (TEER) has become an effective alternative. The GeminiOne is a novel TEER device featuring a unique groove-cam mechanism. This study reports the primary, secondary, and 1-year outcomes of the GeminiOne-DMR (Safety and Efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System in Patients With Moderate-severe or Severe Degenerative Mitral Regurgitation) trial.

Researchers from Chongqing Medical University investigated the independent and combined prognostic value of left atrial reservoir strain (LASr) and global work efficiency (GWE) in secondary mitral regurgitation (SMR), a common and undertreated form of mitral regurgitation associated with poor outcomes in heart failure patients. The retrospective study analyzed 399 medically managed SMR patients (median age 70 years, 66.4% male) using speckle-tracking echocardiography to measure both parameters. Over a median 35-month follow-up, 103 deaths occurred. Cox regression analysis demonstrated that both LASr and GWE independently predicted all-cause mortality, with adjusted hazard ratios of 0.891 and 0.920 per 1% increase respectively. Mediation analysis revealed that GWE accounted for 16.3% of the LASr-mortality association, suggesting that left atrial dysfunction statistically relates to impaired myocardial work efficiency. These findings support integrated assessment of both parameters for improved risk stratification in SMR patients across different severity levels and phenotypes.

Peijia Medical Ltd, a Hong Kong-listed medical device company, has achieved a significant milestone by completing the first patient implant in its US Early Feasibility Study for the GeminiOne transcatheter edge-to-edge repair (TEER) system. This advancement represents the company's formal entry into the US structural heart market with innovative mitral valve repair technology. The GeminiOne system represents Peijia's next-generation approach to addressing mitral valve disease through minimally invasive intervention. While the successful first implant is promising, the company acknowledges substantial risks ahead, including uncertainty surrounding EFS clinical outcomes, FDA regulatory approval requirements, competitive pressures from established TEER device manufacturers, and ongoing reimbursement negotiations. The trajectory of this clinical program will be critical in determining Peijia's competitive positioning within the lucrative structural heart interventions market, where demand for mitral valve repair solutions continues to grow.

Vesalius Vital Inc. has initiated a first-in-human clinical study evaluating the safety and performance of its Transcatheter Mitral Valve Repair (TMVr) System in patients with symptomatic degenerative mitral regurgitation who face elevated surgical risk. The trial will enroll up to five patients in Canada to assess procedural feasibility, technical performance, and short-term clinical outcomes. Using Mitral Valve Academic Research Consortium (MVARC) definitions as endpoints, researchers will measure procedural and device success, freedom from major adverse events, and successful device deployment. The study includes comprehensive monitoring of safety, functional, and hemodynamic parameters at predetermined intervals, with follow-up evaluating valve function, adverse events, and device performance. This preliminary data will be critical for advancing the Vesalius TMVr System toward broader clinical evaluation and potential commercialization, addressing an important need for less invasive treatment options in symptomatic mitral regurgitation patients.

Researchers successfully performed the first transcatheter double valve replacement into native valves using transapical access, marking a significant milestone in interventional cardiology. The case involved a 67-year-old female patient deemed inoperable due to severe mitral annulus calcification and multiple comorbidities. Using multiplanar reconstruction from cardiac CT for preoperative planning, physicians implanted a 29 mm Edwards SAPIEN 3 prosthesis into the mitral valve, followed by a 23 mm SAPIEN 3 into the aortic valve, both under rapid pacing. Both prostheses demonstrated excellent initial function via angiography and echocardiography, with the patient extubated early and discharged to the normal ward the next day. However, after five months, the patient developed cardiac failure due to mitral prosthesis migration, necessitating surgical replacement. This case demonstrates that transcatheter double valve replacement through transapical access is technically feasible, though meticulous preoperative CT planning is essential for proper sizing and anatomical positioning. The finding underscores the need for careful patient selection and long-term monitoring to prevent late complications such as prosthesis migration and left ventricular outflow tract obstruction.

The Emboliner® Full-Body Embolic Protection System is used during interventional heart procedures to capture and remove embolic debris released into the bloodstream which can cause stroke, cognitive decline, acute kidney injury, and other ischemic complications.

Women undergoing M-TEER presented at a more advanced age and with higher symptom burden than men, potentially reflecting sex-specific clinical trajectories and differing MR etiologies. However, midterm outcomes, including all-cause mortality and HF rehospitalization, were comparable between sexes.

Management of patients with chronic primary mitral regurgitation (MR) is based upon an understanding of the pathophysiology and natural history of the disease (table 1) and the efficacy and timing of mitral valve repair and replacement. Primary MR is caused by a primary abnormality in one or more components of the valve apparatus (leaflets, chordae tendineae, papillary muscles, annulus). Mitral valve prolapse (MVP) is the most common cause of chronic primary MR in resource-abundant countries [1]. Rheumatic heart disease is a prominent cause of primary MR in resource-limited countries (particularly during the first two decades of life), but it is an uncommon cause of MR in resource-abundant countries.

In high-risk patients, TMVR with the Tendyne device is associated with acceptable procedure-related morbidity and mortality and leads to mid-term improvement in functional class; however, mid-term survival remains poor.

In this large, real-world cohort, TF TMVR using different dedicated devices was associated with high technical success, durable elimination of MR, functional improvement, and echocardiographic reverse remodeling in patients with available follow-up data. Atrial fibrillation and technical success emerged as key baseline and procedural determinants of outcomes, underscoring the importance of timely intervention and optimal procedural planning. Collectively, these findings support TF TMVR as an effective and durable therapeutic option and reinforce its continued evolution and integration into the contemporary management of mitral valve disease.

Moderate to severe mitral regurgitation frequently accompanies severe aortic stenosis, affecting up to two-thirds of patients requiring aortic valve replacement. This combination may warrant double valve surgery, particularly when mitral regurgitation is severe, degenerative in nature, associated with left atrial dilation, chronic atrial fibrillation, or mitral annular calcium. However, management of mild to moderate mitral regurgitation alongside aortic stenosis remains controversial due to increased surgical risks and limited guideline evidence, which relies primarily on small studies and expert consensus. For patients unsuitable for open surgery, transcatheter aortic valve implantation offers a reasonable alternative strategy, with the potential that mitral regurgitation may improve, become better tolerated, or be addressed through staged transcatheter mitral interventions. This review examines surgical outcomes in combined aortic and mitral valve disease while exploring how transcatheter-based heart valve techniques can address this complex patient population, addressing a significant gap in current clinical guidance for managing multivalve disease.

This article examines transcatheter aortic valve implantation (TAVI) combined with concomitant procedures in high-risk patients with multiple cardiac comorbidities. The case presents a 91-year-old woman with permanent atrial fibrillation and acute heart failure requiring treatment for severe mitral regurgitation and degenerated aortic bioprosthesis. Transoesophageal echocardiography revealed severe calcification of the aortic valve with a mean gradient of 25 mmHg and peak of 40 mmHg, alongside severe eccentric mitral regurgitation from a flail posterior leaflet and pulmonary hypertension at 60 mmHg. The patient's left ventricular ejection fraction was 50%, classified as low-flow, low-gradient aortic stenosis. With a CHA₂DS₂-VASc score of 5 and HAS-BLED score of 4, the patient faced significant thromboembolism and bleeding risks. The article emphasizes that simultaneous transcatheter interventions addressing multiple cardiac diseases represent an appealing strategy in most patients, with the choice between staged versus single-session procedures depending on clinical, anatomical, and patient-specific factors.