How should the extent of coronary artery disease influence revascularization decisions in patients undergoing transcatheter aortic valve replacement (TAVR)? A new PRO-TAVI substudy examines this question using baseline SYNTAX scores in 466 randomized patients. Its central finding is a tradeoff: deferring percutaneous coronary intervention (PCI) reduced bleeding, while the subgroup with the greatest coronary disease burden showed a signal favoring PCI before TAVR for a composite of death, myocardial infarction, and stroke.

Researchers at University Heart and Vascular Center Hamburg conducted a comprehensive analysis of totally endoscopic mitral valve replacement outcomes over a ten-year period. Among 1,037 patients who underwent totally endoscopic mitral valve surgery between 2012 and 2022, 75 patients (7.2%) required chordal-sparing mitral valve replacement rather than repair. The study identified key indications for replacement, including sclerotic leaflets (28.0%), endocarditis (26.7%), mitral stenosis (17.3%), failed repair attempts (17.3%), rheumatic disease (12.0%), and residual regurgitation following transcatheter edge-to-edge repair (7.0%). When compared to propensity score-matched repair patients, replacement cases demonstrated comparable operative times and low cardiac output rates but experienced higher re-thoracotomy rates (14.7% versus 6.7%) and required permanent pacemaker implantation in 16.0% of cases exclusively. Five-year survival rates were 86.7% for replacement versus 94.7% for repair patients, with similar reintervention rates. This research demonstrates that totally endoscopic chordal-sparing mitral valve replacement represents a safe and effective therapeutic option for selected patients at high-volume centers when valve repair is unfeasible.

The Epic™ platform represents a comprehensive line of tissue valves for mitral and aortic applications, combining natural porcine leaflet tissue with advanced engineering since its introduction in 1979. The Epic™ Elite variant introduces an innovative expansion zone that enables predictable low-pressure expansion (5–9 atm) to accommodate larger transcatheter valves during future valve-in-valve interventions, addressing a critical need in lifetime valve management. Key design features include individually selected porcine leaflets for optimal coaptation with minimal calcification, an adaptive cuff engineered to reduce suture drag and paravalvular leak, a flexible Flexfit™ polymer stent, and a unique pericardial shield providing tissue-to-tissue interface protection. The valve demonstrates exceptional hemodynamic performance with reported metrics of 97.3–98.4% across measured parameters. This innovation matters significantly for cardiac surgeons and patients requiring valve replacement, as it eliminates the historical limitation of valve-in-valve compatibility while maintaining strong hemodynamic profiles and durability proven over decades of clinical use.

The mitral valve, positioned between the left atrium and left ventricle, is critical for directing oxygen-rich blood through the heart's main pumping chamber. Mitral valve disease encompasses two primary conditions: mitral regurgitation, where the valve fails to close properly allowing blood to flow backward, and mitral stenosis, where valve narrowing restricts blood flow. Causes include rheumatic heart disease—particularly prevalent in India—as well as degenerative changes, prolapse, congenital abnormalities, previous surgery, and infection. Transcatheter Mitral Valve Replacement (TMVR) represents an alternative to conventional open-heart surgery for selected patients. This catheter-based procedure delivers a replacement valve through the patient's vasculature without requiring chest opening. While TMVR remains a specialized and evolving structural heart treatment rather than a routine surgical substitute, it is increasingly considered for carefully selected high-risk patients when benefits outweigh risks and anatomy permits. A significant application is valve-in-valve TMVR, addressing degeneration in previously implanted bioprosthetic valves. TMVR's development continues to expand treatment options for mitral valve disease in patients for whom traditional surgery presents prohibitive risks.

This study examines initial clip selection strategies and clinical outcomes following mitral valve repair using the MitraClip procedure. The research evaluates how different clip types are selected during percutaneous mitral valve repair interventions and their impact on procedural success and patient outcomes. The investigation analyzes baseline characteristics of patient populations undergoing the procedure, compares procedural and follow-up outcomes stratified by initial clip type selection, and identifies determinants influencing clip selection decisions. Key analyses focus on predictors of residual mitral regurgitation, post-procedural transmitral gradients, and factors necessitating multiple clip implantation. The study employs echocardiographic assessment to evaluate mitral valve anatomy and treatment efficacy, with statistical analyses examining relationships between anatomical features and clinical outcomes. Results from this research provide evidence-based insights into optimal clip selection methodology and demonstrate how initial device choice influences both immediate procedural success and longer-term patient outcomes. These findings are clinically significant as they establish best practices for clip selection strategies in percutaneous mitral repair, potentially improving procedure standardization and patient results across interventional cardiology centers.

MitraClip represents a minimally invasive transcatheter approach to treating mitral regurgitation (MR), a condition where the heart's mitral valve leaflets fail to close properly, causing blood to flow backward into the left atrium. This technique addresses a significant clinical gap by offering an alternative to traditional open-heart surgery for patients considered too high-risk due to age, comorbidities, or other factors. The procedure involves inserting a catheter through the leg and guiding a small metal clip covered with polyester fabric to the mitral valve. The surgeon precisely positions the clip to draw the valve leaflets together, reducing blood regurgitation and alleviating symptoms such as shortness of breath, palpitations, and fatigue. Unlike open-heart surgery requiring months of recovery, MitraClip patients typically recover within days and experience immediate symptom relief. The clip remains in place, moving naturally with the valve while maintaining controlled blood flow. As mitral regurgitation ranks among the most common valve disorders, MitraClip expands treatment options for patients who would otherwise face prohibitive surgical risks or declining heart function.

Transcatheter edge-to-edge repair (TEER) offers a minimally invasive alternative to open-heart surgery for treating mitral regurgitation, a condition where the mitral valve fails to seal properly. A cardiologist threads a catheter through a leg vein to the heart and deploys a small clip that pinches together the two valve leaflets at their center, creating a double opening that closes more completely and reduces backward blood flow. This mechanism works by narrowing the frame through which each leaflet operates, analogous to partially closing swinging doors. Mitral regurgitation causes progressive complications including left atrium enlargement, elevated lung pressure, and potential ventricular weakening, manifesting as breathlessness, fatigue, ankle swelling, and arrhythmias. The procedure represents a significant advancement for patients unsuitable for traditional surgery, particularly elderly individuals. Echocardiography assesses severity and candidacy. While clip repair demonstrates clinical efficacy, the article emphasizes understanding both its capabilities and limitations as a palliative intervention rather than a definitive valve replacement.

The FDA has issued a "potentially high-risk" safety alert regarding Edwards Lifesciences' Commander M delivery system used in transcatheter mitral valve replacement procedures with the SAPIEN M3 mitral valve. The system mechanically collapses the valve onto a deflated balloon catheter for minimally invasive implantation through blood vessels. Edwards received three reports of balloon bursts during inflation, resulting in one patient death and one serious injury as of October 5th. Balloon rupture can cause embolism and device retrieval failure, potentially requiring emergency surgery—a particularly grave concern since patients receiving this therapy are typically ineligible for surgical intervention. The FDA has mandated immediate removal of affected product lots from use. The SAPIEN M3 system, approved by the FDA in December 2025, represents the first transcatheter transseptal therapy approved for treating mitral regurgitation in patients unsuitable for surgery or edge-to-edge repair. The alert underscores ongoing quality concerns with Edwards' delivery systems, following a similar balloon-burst Class I recall of the SAPIEN 3 Ultra system in 2019 affecting 2,579 units.

Patients with symptomatic mitral valve dysfunction complicated by mitral annular calcification represent a challenging population often ineligible for surgery or conventional repair. The ENCIRCLE MAC Registry prospectively evaluated transseptal transcatheter mitral valve replacement using the SAPIEN M3 system in 93 such patients (mean age 76.1 years, 73% in NYHA Class III/IV). At one year, the composite endpoint of all-cause mortality or heart failure hospitalization occurred in 33.6% of patients, including 21.1% mortality and 19.4% hospitalizations. Serious adverse events included disabling stroke in 5.1%, left ventricular outflow tract obstruction in 4.8%, valve thrombosis in 2.3%, and hemolysis requiring intervention in 9.2%. Despite these safety concerns, mitral regurgitation was effectively reduced to ≤1+ in 98.5% of implanted patients, with sustained improvements in functional class and exercise capacity through follow-up. These results suggest transseptal TMVR with SAPIEN M3 can provide a viable treatment option for high-risk patients with calcified mitral valves unsuitable for alternative interventions, though careful patient selection remains essential.

The ENCIRCLE MAC Registry evaluated transseptal transcatheter mitral valve replacement using the SAPIEN M3 system in patients with symptomatic mitral annular calcification-related mitral valve dysfunction who were ineligible for the main ENCIRCLE trial. Of 364 enrolled patients, 100 underwent attempted TMVR (mean age 76 years; 73% with severe heart failure symptoms). The procedure achieved successful implantation in 93% of patients, with one intraprocedural death and seven major cardiac complications. At one year, 99% of implanted patients achieved mitral regurgitation reduction to ≤1+, demonstrating sustained clinical benefit. Kaplan-Meier analysis showed 21% all-cause mortality, 19% heart failure hospitalization rate, and 15% cardiovascular mortality at one year. Secondary outcomes included 5% disabling stroke, 5% clinically significant left ventricular outflow tract obstruction, 2% valve thrombosis, and 9% hemolysis requiring intervention. These results support TMVR's efficacy in this high-risk population with significant comorbidities, offering substantial symptom improvement and quality-of-life gains despite procedural complexity and anatomical challenges.

A 70-year-old female with severe rheumatic aortic stenosis, aortic regurgitation, and hemodynamically significant mitral stenosis presenting with New York Heart Association class III symptoms underwent a novel hybrid minimally invasive procedure combining transfemoral transcatheter aortic valve implantation (TAVI) with direct transatrial valve-in-MAC via right transaxillary minithoracotomy. The patient's heavily calcified aortic valve and severe mitral annular calcification (MAC) made conventional open-heart surgery prohibitively risky. A multidisciplinary Heart Team selected the hybrid approach, with preoperative CT virtual valve simulation using 3mensio software predicting that anterior mitral leaflet resection would expand the neo-left ventricular outflow tract area from a critically reduced 125.9 mm² to a safe 240.8 mm². This tailored strategy allowed direct visualization and manipulation of the calcified annulus while reducing systemic calcium embolization risk and preventing left ventricular outflow tract obstruction. The case demonstrates how advanced imaging, surgical planning, and minimally invasive hybrid techniques can safely address complex, multivalvular disease in high-risk patients who might otherwise be denied intervention.

This study evaluates the real-world clinical performance of a novel balloon-in-basket pulsed field ablation (PFA) system for treating atrial fibrillation. Researchers analyzed 133 consecutive patients with symptomatic paroxysmal or persistent AF who underwent ablation between February 2024 and February 2026. The balloon-in-basket PFA system, integrated with electroanatomical mapping, achieved acute pulmonary vein isolation in 96.2% of cases with mean procedure time of 65.6 minutes. Adjunctive posterior wall isolation was performed in 25.6% of patients, with no significant increase in procedural burden compared to pulmonary vein isolation alone. Only two periprocedural complications occurred (1.5%), involving femoral arterial pseudoaneurysm and pericarditis. Biomarker analyses revealed no hemolysis-related renal safety concerns. Among 82 patients with at least six months follow-up, late atrial arrhythmia recurrence occurred in 14.6%. This real-world experience demonstrates that the balloon-in-basket PFA system provides efficient, safe, and effective ablation for AF, with the capability to perform additional lesion sets when clinically indicated.

This case report documents a rare but critical complication following transcatheter aortic valve implantation (TAVI) in an 88-year-old woman with severe aortic stenosis. Despite preprocedural echocardiography showing only mild septal hypertrophy without significant obstruction, the patient developed acute dynamic left ventricular outflow tract obstruction (LVOTO) immediately after valve deployment—a phenomenon known as suicide left ventricle (SLV). This life-threatening condition resulted from abrupt afterload reduction triggering hypercontractility, systolic anterior motion, and severe mitral regurgitation. Conventional medical management including volume loading, inotrope discontinuation, and beta-blockers proved ineffective, while severe leaflet calcification precluded catheter-based interventions. The clinical team successfully performed totally endoscopic transmitral septal myectomy with mitral valve replacement, resolving the obstruction and regurgitation. The patient recovered fully and was discharged for rehabilitation 132 days postoperatively. This case highlights that while transcatheter therapies are typically preferred for high-risk surgical candidates, totally endoscopic surgery remains a valuable alternative when catheter options are contraindicated, underscoring the importance of rigorous preprocedural risk assessment for SLV development.

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.