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.

Severe acute mitral regurgitation represents a cardiovascular emergency causing rapid pulmonary edema, hypoxemia, and potentially cardiogenic shock through diverse mechanisms including infective endocarditis, chordal rupture, and papillary muscle rupture following myocardial infarction. Patients presenting with acute mitral regurgitation often have significant comorbidities including advanced age, coronary disease, and ventricular dysfunction, complicating treatment approaches. Traditional management relies on medical stabilization through diuretics, vasodilators, and mechanical circulatory support, though these measures frequently prove inadequate as hypotension and renal hypoperfusion can precipitate cardiogenic shock. Surgical mitral valve repair or replacement remains the definitive therapy, but outcomes vary considerably by mechanism and clinical timing. Papillary muscle rupture typically requires urgent surgery, with early mortality exceeding twenty percent in emergency settings and rising to thirty to forty percent in unstable patients. Surgical correction of functional ischemic mitral regurgitation carries lower operative mortality when performed electively, yet randomized and observational data demonstrate no survival advantage for repair over replacement, largely due to high recurrent mitral regurgitation rates. This article examines whether transcatheter edge-to-edge repair techniques might offer improved therapeutic options for acute mitral regurgitation management in high-risk populations.

Mitral transcatheter edge-to-edge repair (M-TEER) represents a catheter-based therapeutic approach for managing mitral regurgitation in select patient populations. The procedure, performed via transseptal access, approximates the mitral valve leaflets to restore coaptation and create a double-orifice configuration, reducing regurgitation. Leading device platforms include MitraClip and PASCAL. The primary evidence-based application targets heart failure patients with reduced ejection fraction and secondary ventricular mitral regurgitation who remain symptomatic despite maximum medical therapy. ACC/AHA guidelines recommend M-TEER with a Class IIa-B rating for appropriately selected candidates meeting specific criteria, including left ventricular ejection fraction of 20–50%, left ventricular end-systolic diameter not exceeding 70 millimeters, and suitable valve anatomy confirmed by transesophageal echocardiography. A distinct phenotype, atrial secondary mitral regurgitation, typically associated with atrial fibrillation and preserved left ventricular function, shows promise in observational studies, demonstrating procedural success, durable mitral regurgitation reduction, and fewer heart failure hospitalizations. However, M-TEER evidence for this population remains observational rather than randomized, with differing recommendations between American and European frameworks regarding surgical eligibility preconditions.

A patient with a degenerated surgical xenograft aortic valve and elevated body mass index presented with recurrent pulseless electrical activity arrests, requiring emergency intervention. The clinical team successfully performed an emergency valve-in-valve transcatheter aortic valve implantation (ViV-TAVI), a minimally invasive technique that positions a new valve within the deteriorated xenograft without removing the original surgical valve. This case demonstrates the critical application of ViV-TAVI as a life-saving alternative to conventional open-heart surgery in hemodynamically unstable patients. The procedure proved particularly valuable given the patient's high body mass index, which typically complicates traditional surgical approaches. This emergency intervention highlights the expanding role of transcatheter technologies in managing acute valvular degeneration and emphasizes how ViV-TAVI can provide rapid hemodynamic stabilization in patients unsuitable for redo surgery. The case contributes important clinical evidence regarding the feasibility and effectiveness of emergency transcatheter techniques in treating degenerated bioprosthetic valves across diverse patient populations, potentially reshaping treatment paradigms for similar high-risk presentations.

Percutaneous mitral repair represents an evolving treatment strategy for secondary mitral regurgitation in heart failure with reduced ejection fraction. Beyond established transcatheter edge-to-edge repair (TEER), emerging approaches include next-generation TEER techniques, transcatheter mitral valve replacement (TMVR), transcatheter annuloplasty, and chordal repair. However, most lack randomized evidence for mortality or heart-failure hospitalization benefits and should not be considered equivalent to trial-supported TEER. TMVR may address anatomies unsuitable for TEER, including short or calcified leaflets and severe annular calcification. The SAPIEN M3 system, a fully percutaneous transseptal device comprising a nitinol dock and balloon-expandable valve, was evaluated in the ENCIRCLE trial for symptomatic moderate-to-severe or severe mitral regurgitation in patients unsuitable for surgery or TEER. However, the trial's 72 percent screening-failure rate highlights restrictive anatomic requirements. Tendyne remains the only commercially approved TMVR system, using a transapical approach with apical tether but with restricted use based on annular calcification severity and life expectancy. Long-term structural durability and reintervention outcomes remain uncertain for these emerging technologies.

This prospective study of 54 consecutive patients examines combined transcatheter edge-to-edge repair using MitraClip and TriClip devices for severe mitral and tricuspid regurgitation, conditions that represent a high-risk patient population with advanced right-heart disease and poor outcomes. The research evaluated the prognostic utility of the TRIVALVE score, previously validated for tricuspid interventions alone, in patients requiring dual-valve repair. Thirty-day mortality was 5.5%, with median follow-up of 607 days revealing 1-year and 2-year survival rates of 91.8% and 64.5% respectively. Logistic regression analysis identified both TRIVALVE score and baseline hemoglobin levels as independent predictors of mortality, while the TRIVALVE score independently predicted the composite endpoint of mortality or heart-failure rehospitalization, with pre-procedural atrial fibrillation and right-heart failure emerging as the strongest predictive components. Machine learning models, particularly random forest analysis, demonstrated strong discriminative performance for predicting follow-up mortality. These findings provide important long-term evidence supporting combined TEER as a viable treatment strategy while establishing the TRIVALVE score's prognostic value in this complex dual-valve patient population.

This study published in JACC: Cardiovascular Interventions presents a one-year comparison of two transcatheter edge-to-edge repair (TEER) devices for mitral valve regurgitation: PASCAL and MitraClip. Both devices represent minimally invasive alternatives to surgical repair, addressing moderate to severe mitral regurgitation in patients who may not be surgical candidates. The research, led by Jafer Haschemi MD and colleagues, evaluates the comparative efficacy and safety outcomes of these two prominent mitral valve repair technologies over a twelve-month follow-up period. This comparison is clinically significant as PASCAL represents newer technology with potential procedural advantages, while MitraClip remains the more established option with extensive clinical data. Understanding the relative performance of these devices is crucial for interventional cardiologists and heart teams making treatment decisions. The findings contribute to the growing body of evidence supporting transcatheter mitral valve interventions as viable alternatives in the expanding landscape of structural heart disease treatment, ultimately informing clinical practice regarding device selection and patient outcomes in mitral valve disease management.

Edwards Lifesciences' PASCAL repair system demonstrates safety and efficacy comparable to Abbott's established MitraClip for treating mitral regurgitation, according to findings published in JACC: Cardiovascular Interventions. Researchers from University Hospital Bern and Cleveland Clinic analyzed 30-day outcomes from an early feasibility study of 62 patients across 14 centers and a prior compassionate use cohort of 23 patients. Results showed high procedural success, with 98% of early feasibility patients achieving mitral regurgitation grade ≤2+, and 86% reaching ≤1+. The mortality rate was 1.6% in the feasibility study and 13% in compassionate use, with no strokes recorded in either group. Major bleeding occurred in 6.5% of feasibility cases. PASCAL's wider paddles, independent leaflet grasping capability, and central spacer represent potential advantages over MitraClip. However, experts emphasize that further investigation is needed regarding PASCAL's role relative to MitraClip and how different mitral valve therapies should be integrated into future clinical practice and trials.

Researchers at San Raffaele University Hospital in Milan conducted a comprehensive retrospective analysis examining the very long-term outcomes of transcatheter edge-to-edge repair (TEER) using Abbott's MitraClip device in patients with severe mitral regurgitation. The study followed 150 consecutive patients treated between October 2008 and January 2013 for an extended period, with the cohort predominantly male (78%) and a median age of 73.2 years. Notably, 71.3 percent had secondary mitral regurgitation caused by left ventricular dysfunction, with a median ejection fraction of 26 percent, representing a complex patient population. Initial procedural success was substantial, though 11.3 percent of patients retained residual mitral regurgitation greater than 3+ at discharge. The study achieved impressive follow-up data retention of 96 percent at a median of 4.6 years. These findings remain clinically significant as they address ongoing debates within the medical community regarding the long-term efficacy and patient selection criteria for MitraClip therapy, particularly for high-risk surgical candidates who previously had limited treatment options for managing severe mitral regurgitation.