Transcatheter mitral valve repair: an overview of current and future devices.
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ABSTRACT:
SUBMITTER: De Backer O
PROVIDER: S-EPMC8094333 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Transcatheter Mitral Valve Repair (TMVRe) technologies constitute a rapidly expanding field, and have the potential of being adopted as a valuable alternative to surgery in selected patients. TMVRe devices can be distinguished depending on the targeted part of the Mitral Valve (MV) apparatus. Standard classification includes leaflet repair, direct/indirect annuloplasty, chordal repair, and ventricular/chamber remodeling devices. We present the current device situation on chordal repair technologies. Nowadays, transapical off-pump beating heart chordal implantation procedure has become a safe and reproducible option for Degenerative Mitral Regurgitation (DMR). Besides the truly minimally-invasiveness of the procedure, another unique advantage offered by a beating-heart chordal implantation is the real-time assessment of chordal length adjustment during heart cycle with a normally filled left ventricle. Currently, one system is commercially available in Europe, the NeoChord DS 1000 (NeoChord, Inc., St. Louis Park, MN) and the Harpoon TDS-5 (Edwards Lifesciences, Irvine, CA) should become available soon. There is also a diffuse and strong interest to move from a transapical procedure toward a fully transcatheter (transfemoral and transeptal) procedure as shown by the increased number of preclinical programs under development. Interestingly, to achieve outcomes that equate to those of open surgery in DMR, transcatheter therapies will need to follow rigid indications due to strict patient selection criteria for each device, or adopt multiple techniques in a single repair procedure for complex MV disease. Continuous analysis of current clinical results together with future dedicated trial will be of extreme importance to foster the new and upcoming field of transcatheter MV therapy technology development.
| S-EPMC6737380 | biostudies-literature
Project description:Mitral regurgitation (MR) is the second most common valvular heart disease and its prevalence is increasing with population ageing. In the recent years we have witnessed the development of several transcatheter devices to correct MR in patients at high-risk for surgery. The majority of evidence regarding safety and efficacy of this new therapy comes from MitraClip studies. However, new alternatives on the field of valve repair have emerged with promising results. The aim of this review is to portrait the landscape of transcatheter mitral repair alternatives, from currently used devices to those that will have a role in the near future.
| S-EPMC7475444 | biostudies-literature
Project description:Many patients affected with mitral valve regurgitation suffer from multiple comorbidities. The MitraClip device provides a safe means of transcatheter valve repair in patients with suitable mitral valve anatomy who are at prohibitive risk for surgery. We describe our early procedural outcomes and present a summary of the current state of MitraClip technology in the United States.We performed a retrospective chart review of initial high-risk or inoperable patients who underwent MitraClip placement at our institution after completion of the EVEREST II study. We examined the primary outcome of 30-day mortality, and secondary outcomes included extent of reduction of mitral regurgitation (MR), New York Heart Association (NYHA) functional class improvement, length of stay, and major complications.A total of 115 high-risk patients (mean Society of Thoracic Surgeons predicted risk of mortality 9.4%±6.1%) underwent the MitraClip procedure at our institution between March 2009 and April 2014. Co-morbidities including coronary artery disease (67.8%), pulmonary disease (39.1%) and previous cardiac surgery (44.3%) were common. The device was placed successfully in all patients with a 30-day mortality of 2.6%. All patients demonstrated 3+ or 4+ MR on preoperative imaging, and 80.7% of patients had trace or 1+ MR at hospital discharge. NYHA class improved substantially, with 79% of patients exhibiting class III or IV symptoms pre-procedure and 81% reporting class I or II symptoms at one month follow-up.The MitraClip procedure provides a safe alternative to surgical or medical management for high-risk patients with MR and suitable valve anatomy. A comprehensive heart team approach is essential, with surgeons providing critical assessment of patient suitability for surgery versus percutaneous therapy as well as performance of the valve procedure.
| S-EPMC4526504 | biostudies-other
Project description:This review outlines the first trial experience with transcatheter therapy for mitral regurgitation (MR), developed from the EVEREST II MitraClip trial in a trial population comprised predominantly of patients with degenerative mitral regurgitation (DMR). Subsequent experience with MitraClip and several other devices has been mostly in functional MR patients. At the same time, there has been ongoing experience with MitraClip in DMR, and a variety of other devices have been developed for catheter-based treatment of MR. Annuloplasty devices have been indicated for DMR, and the potential for transcatheter annuloplasty to be used, in conjunction with other catheter techniques, such as chordal replacement, as it is in standard mitral repair, is developing. Transcatheter mitral valve replacement will clearly have some role for MR of both functional and degenerative etiologies, when repair is not feasible or fails. This review will discuss the evidence base and future development of these mitral repair and replacement approaches for DMR.
| S-EPMC6288224 | biostudies-other
Project description:BACKGROUND:Mitral regurgitation is a heterogeneous disease. Determining which patients derive optimal outcomes from transcatheter edge-to-edge mitral valve repair (TMVR) remains challenging. We sought to determine whether baseline mitral valve anatomic characteristics are predictive of left atrial pressure (LAP) changes during TMVR with MitraClip. METHODS AND RESULTS:Consecutive patients with severe mitral regurgitation undergoing TMVR (n=112) underwent continuous intraprocedural LAP monitoring and retrospective echocardiographic analysis for specific mitral anatomic characteristics. Procedural success (optimal LAP reduction) was defined as ?40% reduction in left atrial V-wave pressure compared with baseline. Echocardiographic predictors of optimal LAP reduction and increased postprocedure mean diastolic gradient were evaluated. Mean age was 79±14 years, and 36 patients (32%) were women. Primary, mixed, and secondary mitral regurgitation were present in 78 patients (70%), 22 patients (20%), and 12 patients (10%), respectively. Baseline mean LAP and V-wave were 22±6 and 38±13 mm Hg; after TMVR, these decreased to 19±5 and 27±10 mm Hg, respectively (P<0.0001 for both). Independent predictors of optimal LAP reduction were the presence of a flail scallop, mitral regurgitation localized to a single scallop, and high-quality 3-dimensional echocardiographic imaging. Independent predictors of elevated postprocedure mean diastolic gradient were elevated preprocedure mean diastolic gradient, mitral annular calcification, and implantation of multiple clips. CONCLUSIONS:Mitral valve pathoanatomic features, including a flail leaflet and single jet, are predictive of optimal LAP reduction with TMVR. High-quality 3-dimensional imaging may help select patients with the highest likelihood of optimal hemodynamic results with TMVR. These data expand current knowledge about patient selection for TMVR and deserve further study in larger cohorts.
| S-EPMC5850157 | biostudies-literature
Project description:Background Transcatheter mitral valve repair (TMVr) is currently offered at selected centers that meet certain operator and institutional requirements. We sought to explore the hypothesis that the availability of TMVr is associated with improved outcomes of MV surgery. Methods and Results We used the Nationwide Readmissions Database to identify patients who underwent MV surgery at centers with or without TMVr capabilities between January 1 and December 31, 2017. The primary end point was in-hospital mortality. Secondary end points were postoperative complications, resource use, and 30-day readmissions. A total of 24 477 patients from 595 centers (446 TMVr, 149 non-TMVr) were included. There were modest but statistically significant differences in the prevalence of comorbidities between the groups. Patients at non-TMVr centers had higher unadjusted in-hospital mortality than those at TMVr centers (5.6% versus 3.6%, P<0.001). They also had higher rates of postoperative complications, longer hospitalizations, higher cost, and fewer home discharges but similar 30-day readmission rates. After propensity matching, mortality remained higher at non-TMVr centers (5.5% versus 4.0%, P<0.001). Rates of postoperative complications, prolonged hospitalizations, and nonhome discharges also remained higher. Postoperative mortality was consistently higher at non-TMVr centers in multiple risk-adjustment analyses incrementally accounting for differences in risk factors, surgical volume, availability of surgical repair, and excluding concomitant procedures. In the most comprehensive model, surgery at non-TMVr centers was associated with higher odds of death (odds ratio, 1.41; 95% CI, 1.14-1.73; P=0.002). Conclusions Mitral valve surgery at TMVr centers is associated with improved in-hospital outcomes compared with non-TMVr centers.
| S-EPMC8174333 | biostudies-literature
Project description:Over the past decade, several transcatheter devices have been developed to address the treatment of severe mitral regurgitation (MR) in patients at high surgical risk, mainly aimed at repairing the native mitral valve (MV). MV repair devices have recently been shown to have high efficacy and safety. However, to replicate promising trial results, specific anatomical and pathophysiological criteria have to be met and operators need a high level of experience. As yet, the longer-term durability of transcatheter MV repair remains unknown. Transcatheter MV replacement (TMVR) might be a treatment option able to target various anatomies, reliably abolish MR, and foster ease of use with a standardised implantation protocol. This review presents upcoming TMVR devices and available data and discusses how TMVR might further advance the field of transcatheter treatment of MR.
| S-EPMC8135015 | biostudies-literature
Project description:A patient with severe mitral regurgitation and chronic systolic heart failure taking inotropic support at home presents for transcatheter edge-to-edge mitral valve repair, complicated by torrential mitral regurgitation from damaged mitral leaflets requiring escalating mechanical circulatory support and ultimately expedited orthotopic heart transplantation. (Level of Difficulty: Intermediate.).
| S-EPMC8305671 | biostudies-literature
Project description:Mitral regurgitation remains the most common form of valve disease worldwide and given an aging population with a significant proportion of secondary mitral regurgitation, a transcatheter approach to mitral valve replacement has become a major goal of the transcatheter therapeutics field. Mitral regurgitation can be caused by disease of the leaflets (primary) or by diseases of the left atrium or left ventricle (LV) (secondary or functional), and may involve overlap of the two (mixed disease). The location of the mitral valve (and large size), the approach to anchoring a valve replacement, and concerns about left ventricular outflow tract (LVOT) obstruction are all issues that have made the transcatheter delivery of a valve replacement challenging. Despite these challenges, both transapical and transseptal devices are currently being developed, with several in early feasibility trials and several entering pivotal trials. As the field of transcatheter mitral valve replacement (TMVR) improves and develops, a critical part of evaluating patients with mitral valve disease will be utilizing the heart team approach to identify and individualize the most appropriate treatment for each patient.
| S-EPMC7867435 | biostudies-literature
Project description:BackgroundBleeding in the context of cardiac catheterization is frequent and negatively impacts on short- and long-term patient outcome. We evaluated the clinical impact of in-hospital bleeding events after transcatheter mitral valve repair (TMVr) in the long-term follow- up.Methods586 consecutive patients treated with first-time TMVr were enrolled in this registry. In-hospital MVARC (Mitral Valve Academic Research Council) bleedings were assessed and patients were grouped according to the incidence of a bleeding event. Multivariate logistic regression was used to identify significant independent predictors of MVARC bleeding. This study received approval by local ethics committee.Results78 patients (13.3%) suffered from an MVARC bleeding event (Access site-related bleedings: 46.2%; GI tract bleeding: 35.9%; Other bleedings: 17.9%). Among these bleeding subgroups, neither relevant differences in baseline characteristics nor in severity of bleeding events were observed. Despite not being an independent predictor for overall death in the multivariate Cox regression analysis, MVARC bleeding was associated with prolonged hospital stay. The ORBIT bleeding score was the best match to predictors of any MVARC bleeding found in our cohort (c-score overall cohort: 0.68; c-score GI bleeding cohort: 0.72).ConclusionMVARC bleedings after TMVr are frequent findings but were only in half of the cases related to the access site. The ORBIT score could be useful for identification of patients at high risk for non-access site bleeding and especially GI bleeding.
| S-EPMC7797941 | biostudies-literature