Transcatheter mitral valve replacement: an update.

Transcatheter mitral valve intervention (TMVI) has emerged as a potential alternative to surgery for patients with mitral annular calcification (MAC)-associated mitral valve disease, a population often deemed high-risk due to clinical and anatomic complexities. However, MAC also presents significant challenges to TMVI itself. In transcatheter edge-to-edge repair (TEER), procedural success may be limited by fibrotic and short leaflets, reduced mitral valve area, and subvalvular calcium protrusion. Transcatheter mitral valve replacement (TMVR) poses further anatomical hurdles, including a small, eccentric, or non-conforming annuli; insufficient MAC to ensure anchoring; narrow aortomitral angle; septal hypertrophy; elongated anterior mitral leaflet predisposing to left ventricular outflow tract (LVOT) obstruction; and heterogeneous MAC morphology leading to paravalvular leak or suboptimal fixation. Mechanical injury to adjacent structures such as the circumflex artery and atrioventricular groove is also a concern. Balloon-expandable valves, used off-label for TMVR, may be delivered via transapical, transfemoral, transseptal, or hybrid transatrial approaches. While early data show high mortality for valve-in-MAC (ViMAC) procedures, a shift toward transfemoral transseptal access has improved outcomes. The hybrid transatrial approach offers advantages including resection of the anterior leaflet, septal myectomy, and reinforcement of the valve skirt with Teflon felt. Among dedicated self-expanding TMVR systems, only Tendyne has both CE mark and US Food and Drug Administration (FDA) approval and is delivered transapically. New transfemoral transseptal systems—such as Intrepid, AltaValve, and Cephea—are under active investigation. Techniques like LAMPOON (Laceration of the Anterior Mitral leaflet to Prevent Outflow ObstructioN) and BATMAN (Balloon-Assisted Translocation of the Mitral Anterior Leaflet) have been developed to mitigate the risk of fatal LVOT obstruction. Despite progress, mid-term mortality after ViMAC TMVR remains high. Continued innovations in technique, device design, and patient selection are critical to establishing TMVI as a viable treatment for MAC-associated mitral valve disease.

The HighLife transcatheter mitral valve replacement system: A novel two-component platform.

ECHOCARDIOGRAPHIC OUTCOMES FOLLOWING EDWARDS TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM FOR SIGNIFICANT MITRAL REGURGITATION: A SINGLE CENTRE EXPERIENCE

Objective: To preliminarily assess the biocompatibility and durability of the TruDeltaTM transcatheter mitral valve replacement (TMVR) system. Method: Six adult sheep were divided into 3 groups based on the duration of follow-up: 30 days (n=1), 90 days (n=3) and 180 days (n=2). The TruDeltaTM TMVR system was implanted through a transapical approach under transesophageal echocardiographic guidance. The operability of the TMVR system was evaluated using an instrument performance evaluation scale (consisting of 39 items), with scores ranging from 1 (worst) to 10 (best) assigned by the operator. Echocardiography was conducted preoperatively, immediately after surgery, and at 30, 90, and 180 days post-implantation. At the last follow-up time point, the intervention mitral valve membrane and major organs were dissected for observation. The artificial valves were taken for hematoxylin eosin (HE) staining and observed under a scanning electron microscope. Result: All six procedures were successfully completed using 29S size TruDeltaTM TMVR device. At the final follow-up, echocardiogram demonstrated good valve function without obvious paravalvular leakage, with a transvalvular gradient of (7.8±3.2) mmHg (1 mmHg=0.133 kPa) and a mitral valve orifice area of (1.8±0.2) cm2. Autopsy findings revealed no structural valve failure and almost complete endothelialization (>75%) with 90 to 180 days. Both HE staining and scanning electron microscopy confirmed optimal endothelialization of the valve stent. Conclusion: The preclinical animal study indicates that the TruDeltaTM device exhibits favorable biocompatibility and durability.

Minimally invasive treatment of mitral valve disease with severe mitral annular calcification: Meeting paper for Mitral Conclave 2022.

Breaking the Mold: Lithotripsy for Mitral Annular Calcification.

Secondary mitral regurgitation (MR) results from left ventricular dilatation and dysfunction. Quantification of secondary MR is challenging because of the underlying myocardial disease. Clinical and echocardiographic evaluation requires a multi‐parametric approach. Severe secondary MR occurs in up to one‐fourth of patients with heart failure with reduced ejection fraction, which is associated with a mortality rate of 40% to 50% in 3 years. Percutaneous edge‐to‐edge mitral valve repair (MitraClip) has emerged as an alternative to surgical valve repair to improve symptoms, functional capacity, heart failure hospitalizations, and cardiac haemodynamics. Further new transcatheter strategies addressing MR are evolving. The Carillion, Cardioband, and Mitralign devices were designed to reduce the annulus dilatation, which is a frequent and important determinant of secondary MR. Several transcatheter mitral valve replacement systems (Tendyne, CardiAQ‐Edwards, Neovasc, Tiara, Intrepid, Caisson, HighLife, MValve System, and NCSI NaviGate Mitral) are emerging because valve replacement might be more durable compared with valve repair. In small studies, these interventional therapies demonstrated feasibility and efficiency to reduce MR and to improve heart failure symptoms. However, neither transcatheter nor surgical mitral valve repair or replacement has been proven to impact on the prognosis of heart failure patients with severe MR, which remains high with a mortality rate of 14–20% at 1 year. To date, the primary indication for treatment of secondary severe MR is the amelioration of symptoms, reinforcing the value of a Heart Team discussion. Randomized studies to investigate the treatment effect and long‐term outcome for any transcatheter or surgical mitral valve intervention compared with optimized medical treatment are urgently needed and underway.

We report our experience with the CardiAQ prosthetic valve using both transapical and transseptal access. Aim of our study was proving the feasibility, safety and effectiveness of a novel transcatheter mitral valve bioprosthesis. Four patients with severe mitral regurgitation, not eligible for mitral valve surgery, were treated with the CardiAQ valve. The procedures were performed under general anaesthesia, fluoroscopic and transesophageal echocardiographic guidance. We used a transapical approach in two patients and transseptal access in the others. Procedural success was obtained in all patients without extracorporeal circulation support. Mean procedure time was 128 min (range 90-180) and mean hospitalization duration was 12 days (range 4-24). The transseptal approach resulted in significantly shorter in-hospital stay with quick recovery. One patient died on day 35 from septicaemia and another one died after 5 months from major bleeding. The survival patients are presently in New York Heart Association I-II with improved left ventricular ejection fraction and normal quality of life. CardiAQ valve placement is safe using a transapical or transseptal approach. Following valve replacement, there was a marked functional improvement in survivors. Transcatheter mitral valve replacement is a promising therapy for mitral regurgitation in a selected patient population.

Outcomes After Transcatheter Mitral Valve Replacement According to Regurgitation Etiology

2019 AATS/ACC/ASE/SCAI/STS expert consensus systems of care document: A proposal to optimize care for patients with valvular heart disease: A joint report of the American Association for Thoracic Surgery, American College of Cardiology, American Society of Echocardiography, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons

Mitral annular calcification with valve dysfunction remains a challenging syndrome. Operative risk is high, and available transcatheter therapies are limited. This study describes our initial experience with a novel procedure to address large mitral annuli when no surgical or trial-based transcatheter mitral valve replacement device is available. The rationale was to shorten the intercommissural distance using commissural mitral transcatheter edge-to-edge repair (TEER) followed by valve-in-mitral annular calcification transcatheter mitral valve replacement with a balloon-expandable aortic valve platform. Patients with long intercommissural distances and large mitral annulus areas were selected based on a high perceived risk of transcatheter valve embolization. Patients underwent mitral TEER with MitraClip in a commissural position, followed immediately by transseptal transcatheter mitral valve replacement with a 29 mm SAPIEN 3 valve. Thirteen patients were included. Median intercommissural distance and annular area were 39.1 mm and 930 mm2, respectively. Commissural mitral TEER was successful in all patients with no instances of single leaflet detachment. In 10 of 13 instances, an NTW device size was used. In 12 of 13 patients, valve implantation was successful, including 1 case that required a second valve for atrial positioning of the first valve. In 1 case, frank valve embolization into the left atrium occurred. Among the 12 successful cases, paravalvular leak was 1+ or less, and there were no instances of paravalvular leak adjacent to the TEER device. In patients with large annuli and sufficient annular calcium, a hybrid mitral TEER and valve replacement with the SAPIEN platform can be successfully used to facilitate transcatheter mitral valve replacement.

After aortic valve stenosis, mitral regurgitation (MR) is the second most common valvular disease, particulary affecting older patients. Optimal medical treatment within the context of heart failure therapy is the favored first-line therapy for secondary MR. If symptoms persist despite optimal medical therapy, surgical or transcatheter mitral valve repair is indicated (recommendation class IIb). In contrast, surgical treatment is essential for patients with symptomatic primary MR and left-ventricular ejection fraction (LVEF) >30% and justifiable perioperative risk (repair preferred over replacement, recommendation classI); for high-risk patients, interventional transcatheter mitral valve repair (especially by "edge-to-edge-reconstruction") is aviable option (recommendation class IIb).Recently, transcatheter mitral valve replacement (TMVR) has come into focus as another attractive treatment option and is currently under intensive research. At first, the TMVR was used both for patients with symptomatic insufficiency or stenosis after biological mitral valve replacement (Bio-MKE) or after reconstruction as a"valve-in-valve" or "valve-in-ring" procedure. Therefore, transcatheter aortic valve prostheses were used.In the past few years several dedicated TMVR prostheses were developed for the treatment of native MR. So far, no TMVR prosthesis is CE-certified. All of the following TMVR methods are under clinical evaluation in the scope of pivotal trials. The interdisciplinary heart team, consisting of experienced cardiologists and heart surgeons develops apatient-specific, individual treatment concept considering the particular MR etiology, pre-existing comorbidities, age, clinical symptoms, and status.

Innovalve transcatheter mitral valve replacement system: Short-term pre-clinical study in pigs

Current and Investigational Transcatheter Mitral Valve Replacement Systems: A Narrative Review for the Cardiac Anesthesiologist

Functional mitral regurgitation (FMR) is characterized by normal mitral leaflet morphology but a dilated mitral annulus due to left ventricular dilatation or papillary muscle dysfunction [1]. The prevalence of FMR is increasing due to predicted demographic changes and it is estimated that by 2030, 4 million people will be diagnosed with FMR in the United States [2]. Patients with FMR are typically treated with guideline-directed medical therapy (GDMT) but when symptoms occur despite GDMT, surgery or transcatheter intervention is indicated before left ventricular function further deteriorates. Recently, transcatheter edge-to-edge mitral valve repair (TEER) has emerged as a promising treatment modality in this regard. However, there is insufficient data comparing the effectiveness of TEER to the more commonly employed surgical mitral valve repair (SMVr). To explore this gap, Wang et al. recently presented a real-world analysis comparing the outcomes of TEER and SMVr in patients with FMR by using data from the National Inpatient Sample (NIS) database [3]. In 6233 and 2524 patients who underwent SMVr and TEER, respectively, the length of hospital stay was considerably shorter for TEER with a mean of 8.59 days for SMVr and 4.13 days for TEER. While the in-hospital mortality rate was similar in both groups, the study showed that SMVr was associated with increased perioperative complications such as cardiogenic shock, cardiac arrest, respiratory failure, fluid and electrolyte disorders, acute kidney injury, cerebrovascular infarction, and bleeding after the procedure. Postprocedural blood transfusion and mechanical ventilation use were also higher in the SMVr group. This comprehensive study provides valuable data and a nuanced understanding of the comparative outcomes between transcatheter and surgical approaches to mitral valve repair. The meticulous analysis and detailed presentation of results significantly contribute to the field of cardiovascular medicine, offering a robust foundation for future research and clinical practice. For certain patients with anatomical features that make TEER challenging or not feasible, and where surgical risk remains high and prohibitive, transcatheter mitral valve replacement (TMVR) has recently emerged as an attractive option [4]. While a number of transcatheter replacement devices are under development and clinical investigation, their current use is largely limited to compassionate cases or clinical trials. Consequently, TEER is the first-line transcatheter treatment for both mitral and tricuspid regurgitation in many patients who are not candidates for surgery [5]. However, several limitations should be addressed in future research to enhance the robustness of the findings. The study's lack of laboratory or echocardiography data is a notable limitation, and subsequent studies should incorporate these assessments both pre- and postsurgery. Conducting randomized controlled trials with standardized data collection protocols across multiple centers will provide more robust evidence, aiding in the development of evidence-based guidelines for managing mitral valve disease. Additionally, the absence of specific information on the transcatheter mitral valve repair (TMVr) devices used, as well as data on resource utilization and procedural trends, limits the study's applicability. Specification of the devices used and detailed information on resource utilization and trends by region and time will help provide better insight. The lack of subgroup data on TMVr, which is generally riskier and used for specific clinical and anatomical reasons, is another significant limitation. Future studies should include detailed subgroup analyses to better understand TMVr outcomes and tailor treatments to specific patient populations. Lastly, the NIS database's lack of longitudinal tracking prevents the assessment of long-term outcomes. To address this issue, databases capable of longitudinal follow-up should be used to provide a comprehensive understanding of the long-term efficacy and safety of both TMVr and SMVr. Addressing these limitations will significantly enhance the quality and applicability of future research in this critical area of cardiovascular medicine. Ibrahim Manzoor came up with the idea for the letter and wrote the manuscript. Mustafa Mansoor helped in finalizing the manuscript and provided supportive ideas for its completion. The authors received no specific funding for this work. The authors declare no conflicts of interest. Data sharing is not applicable to this article as no new data were created or analyzed in this study.