Transcatheter devices for direct annuloplasty and chordal replacement in degenerative mitral regurgitation.
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ABSTRACT:
SUBMITTER: Edelman JJ
PROVIDER: S-EPMC7867436 | biostudies-literature | 2021 Jan
REPOSITORIES: biostudies-literature
Publications
Transcatheter devices for direct annuloplasty and chordal replacement in degenerative mitral regurgitation.
Edelman J James JJ Meduri Christopher U CU Yong Gerald G Thourani Vinod H VH
Annals of cardiothoracic surgery 20210101 1
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Project description:AimsSeveral approaches for transcatheter mitral valve repair for functional mitral valve regurgitation are established. Interventional direct annuloplasty is a novel trans-venous, trans-septal approach. While feasibility was proven recently, knowledge on its influence on cardiac dimensions, pressures, biomarkers, and clinical outcomes is sparse.Methods and resultsPatients consecutively treated with direct annuloplasty-only procedures between December 2015 and April 2018 were included in this monocentric analysis. Echocardiographic measurements, biomarker levels, clinical status [New York Heart Association (NYHA) class and 6 min walk test] were assessed at baseline, at discharge, and at a 30 day follow-up. Overall, 18 patients (in mean 77.0 ± 7.4 years, 44.4% women) with initially all high-grade mitral valve regurgitation (MR) were included in this study. Procedural success rate was high (94.4%) without severe complications. Direct annuloplasty resulted in MR-reduction (post-procedural-MR mild or no/trace: 72.2%) and the proportion of patients with severe dyspnoea (NYHA III/IV) was reduced (88.9% vs. 50%, P = 0.008). Clinical results were associated with a relevant diminution of left atrial volumes (-16.5%, P < 0.001) and cardiac pressures [left atrial pressure (-32.3%, P = 0.019) and systolic pulmonary arterial pressure (PAP, -15.8%, P = 0.025)]. Patients with lower baseline levels of PAP (P = 0.022) as well as elevated highly sensitive troponin (P = 0.034) were more likely to archive clinical benefit (improvement in NYHA class ≥1 grade) after 1 month, which could not be correlated with the grade of MR-reduction.ConclusionsTranscatheter mitral valve repair by direct annuloplasty results in a relevant reduction of intracardiac pressures, left atrial volumes, dyspnoea, and MR. Lower PAP and higher troponin values at baseline could be associated to dyspnoea reduction.
| S-EPMC7755018 | biostudies-literature
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:Patients undergoing transcatheter aortic valve replacement (TAVR) might have an associated significant MR that can potentially lead to left ventricular (LV) failure after procedure. Considering the specific alterations in the mitral valve in TAVR scenario and the widespread use of TAVR in recent years, it appears important to know and understand the anatomical, functional and clinical implications to develop adequate strategies for the future. Patients with severe mitral regurgitation (MR) have been generally excluded from randomized clinical trials, making poor the impact that associated MR can have on clinical outcomes after TAVR. Several factors must be considered whose presence influences the severity of MR. For example, the elevated prevalence of coronary disease with consequent ischemic MR may account for LV dilation observed at the end stage of aortic stenosis. Evidence randomized studies and registries suggests that the rate of concomitant moderate-to-severe MR in patients undergoing TAVR oscillates between 2% and 33%, and patients with moderate to severe MR may have hemodynamic frailty with clinical deterioration during mechanical intervention. Short- and long-term outcomes, including cardiac mortality, appear to be influenced by the existence of preoperative moderate-to-severe MR or by the postprocedural worsening of mild MR, generally due to adverse LV remodeling. The incidence and the prognostic effect of concomitant MR in patients undergoing TAVR requires specific attention as might trigger adjunctive strategy treatment which should be carefully evaluated in clinical trials.KeywordsMitral regurgitation (MR); mitral valve; transcatheter aortic valve; transcatheter aortic valve replacement (TAVR)
| S-EPMC7330403 | biostudies-literature
Project description:AIMS:Mitral annuloplasty using the Carillon Mitral Contour System (CMCS) reduces secondary mitral regurgitation (SMR) and leads to reverse left ventricular remodelling. The aim of this study was to evaluate the effect of the CMCS on the mitral valve annulus (MA) and left atrial volume (LAV). METHODS AND RESULTS:We retrospectively evaluated the data of all patients treated with the CMCS at our centre. Using transthoracic echocardiography, MA diameters were assessed by measuring the anterolateral to posteromedial extend (ALPM) and the anterior to posterior (AP) dimensions, respectively. Also, LAV and left ventricular end-diastolic volume (LVEDV) were assessed. Patients were examined at three time points: baseline, at 20-60 days (30dFUP), and at 9-15 months (1yFUP), using paired analysis. From July 2014 until March 2019, 75 cases of severe SMR were treated using CMCS. Cases in which other devices were used in combination (COMBO therapy, n = 35) or in which the device could not be implanted (implant failure, n = 3) were excluded, leaving 37 patients in the present analysis. Analysis at 30dFUP showed a significant reduction of 16% in the mean ALPM diameter (7.27 ± 5.40 mm) and 15% in the AP diameter (6.57 ± 5.33 mm). Analysis of LAV also showed a significant reduction of 21% (36.61 ± 82.67 mL), with no significant change in LVEDV. At 1yFUP, the reduction of both the mean ALPM diameter of 14% (6.24 ± 5.70 mm) and the mean AP diameter of 12% (5.46 ± 4.99 mm) remained significant and stable. The reduction in LAV was also maintained at 23% (37.03 ± 56.91 mL). LAV index was significantly reduced by 17% at 30dFUP (15.44 ± 40.98 mL/m2 ) and by 13% at 1yFUP (11.56 ± 31.87 mL/m2 ), respectively. LVEDV index showed no significant change at 30dFUP and a non-significant 10% reduction at 1yFUP (17.75 ± 58.79 mL/m2 ). CONCLUSIONS:The CMCS successfully treats symptomatic SMR with a stable reduction of not only the AP diameter of the MA, but the current study also demonstrates an additional reduction of the ALPM dimension at both 30dFUP and 1yFUP. We have also shown for the first time that LAV and LAV index are significantly reduced at both 30dFUP and 1yFUP and a non-significant positive remodelling of the LVEDV. This positive left atrial remodelling has not been looked for and demonstrated in earlier randomized studies of CMCS.
| S-EPMC7373883 | biostudies-literature
Project description:Mitral regurgitation (MR) is a frequent valvular disease among patients deemed too high risk for surgery. Echocardiography along with CT is the primary diagnostic tool for MR and offers a comprehensive 3D assessment in patient selection and screening for the optimal treatment method. The direct percutaneous mitral annuloplasty addresses the underlying mechanisms of functional MR with a less invasive, catheter-based approach. The here-described techniques proved a sufficient safety profile, delivered significant MR reduction in most of the cases, and were associated with a notable improvement of symptoms. Although long-term outcome assessment is needed to support these early reports, the percutaneous mitral annuloplasty is likely to set a new standard of treatment in the forthcoming future.
| S-EPMC6855240 | biostudies-literature
Project description:To analyse the impact of postprocedural mitral regurgitation (MR), in an interaction with aortic regurgitation (AR), on mortality following transcatheter aortic valve implantation (TAVI).To assess the interaction between MR and AR, we compared the survival rate of patients (i) without both significant MR and AR versus (ii) those with either significant MR or significant AR versus (iii) with significant MR and AR, all postprocedure. 381 participants of the Polish Transcatheter Aortic Valve Implantation Registry (166 males (43.6%) and 215 females (56.4%), age 78.8±7.4 years) were analysed. Follow-up was 94.1±96.5 days.In-hospital and midterm mortality were 6.6% and 10.2%, respectively. Significant MR and AR were present in 16% and 8.1% patients, including 3.1% patients with both significant MR and AR. Patients with significant versus insignificant AR differed with respect to mortality (log rank p=0.009). This difference was not apparent in a subgroup of patients without significant MR (log rank p=0.80). In a subgroup of patients without significant AR, there were no significant differences in mortality between individuals with versus without significant MR (log rank p=0.44). Significant MR and AR had a significant impact on mortality only when associated with each other (log rank p<0.0001). At multivariate Cox regression modelling concomitant significant MR and AR were independently associated with mortality (OR 3.2, 95% CI 1.54 to 5.71, p=0.002).Significant MR or AR postprocedure, when isolated, had no impact on survival. Combined MR and AR had a significant impact on a patient's prognosis.
| S-EPMC4862065 | biostudies-other
Project description:We developed and tested a novel transcatheter circumferential annuloplasty technique to reduce mitral regurgitation in porcine ischemic cardiomyopathy.Catheter-based annuloplasty for secondary mitral regurgitation exploits the proximity of the coronary sinus to the mitral annulus, but is limited by anatomic variants and coronary artery entrapment.The procedure, "cerclage annuloplasty," is guided by magnetic resonance imaging (MRI) roadmaps fused with live X-ray. A coronary sinus guidewire traverses a short segment of the basal septal myocardium to re-enter the right heart where it is exchanged for a suture. Tension is applied interactively during imaging and secured with a locking device.We found 2 feasible suture pathways from the great cardiac vein across the interventricular septum to create cerclage. Right ventricular septal re-entry required shorter fluoroscopy times than right atrial re-entry, which entailed a longer intramyocardial traversal but did not cross the tricuspid valve. Graded tension progressively reduced septal-lateral annular diameter, but not end-systolic elastance or regional myocardial function. A simple arch-like device protected entrapped coronary arteries from compression even during supratherapeutic tension. Cerclage reduced mitral regurgitation fraction (from 22.8 +/- 12.7% to 7.2 +/- 4.4%, p = 0.04) by slice tracking velocity-encoded MRI. Flexible cerclage reduced annular size but preserved annular motion. Cerclage also displaced the posterior annulus toward the papillary muscles. Cerclage introduced reciprocal constraint to the left ventricular outflow tract and mitral annulus that enhanced leaflet coaptation. A sample of human coronary venograms and computed tomography angiograms suggested that most have suitable venous anatomy for cerclage.Transcatheter mitral cerclage annuloplasty acutely reduces mitral regurgitation in porcine ischemic cardiomyopathy. Entrapped coronary arteries can be protected. MRI provided insight into the mechanism of cerclage action.
| S-EPMC3034128 | biostudies-other
Project description:AimsThe study sought to investigate the long-term outcome after transcatheter mitral valve annuloplasty for secondary mitral regurgitation (MR).Methods and resultsConsecutive patients with symptomatic secondary MR undergoing transcatheter mitral valve annuloplasty with the Carillon device at Leipzig University Hospital between 2012 and 2018 were studied prospectively. Left ventricular (LV) function and MR severity were quantified by standardized echocardiography. 33 patients were included. Mean age was 75 ± 10 years, and 20 patients were women. A Society of Thoracic Surgeons score of 8.1 ± 7.2% indicated high-risk status. In 24 patients, MR resulted from LV remodelling and dysfunction, eight suffered from left atrial dilatation, and one patient had MR due to combined primary and secondary aetiology. LV ejection fraction at baseline was (median) 38% [inter-quartile range (IQR) 30-49%]. During the mean follow-up time of 45 ± 20 months, 17 patients died, two patients withdraw consent, and four patients were lost. Of the remaining patients, four were hospitalized for decompensated heart failure. Two of these patients underwent additional transcatheter edge-to-edge mitral valve repair. At follow-up, New York Heart Association (NYHA) functional class improved from 95% in Class III/IV at baseline to 70% in Class I/II with no patients in NYHA Class IV (P < 0.0001). Mitral regurgitant volume was reduced from 27 mL (IQR 25-42 mL) to 8 mL (IQR 3-17 mL) (P = 0.018) and regurgitant fraction from 42% (IQR 34-54%) to 11% (IQR 8-24%) (P = 0.014). LV end-diastolic volume index [92 mL/m2 (IQR 74-107 mL/m2 ) vs. 67 mL/m2 (IQR 46-101 mL/m2 ), P = 0.065] and end-systolic volume index [50 mL/m2 (IQR 44-69 mL/m2 ) vs. 32 mL/m2 (IQR 20-53 mL/m2 ), P = 0.037] decreased. Total stroke volume remained unchanged [38 mL/m2 (IQR 33-43 mL/m2 ) vs. 33 mL/m2 (IQR 26-44 mL/m2 ), P = 0.695], while LV ejection fraction increased [43% (IQR 35-49%) vs. 54% (IQR 46-57%), P = 0.014]. Forward stroke volume, heart rate, and forward cardiac output were not significantly altered.ConclusionsAmong high-risk patients undergoing transcatheter mitral valve annuloplasty for symptomatic secondary MR, mortality was ~50% at 4 years. In the surviving patients, reduced MR severity was associated with reduced NYHA functional class, reverse LV remodelling, and improved LV function.
| S-EPMC8318490 | biostudies-literature
Project description:Transcatheter mitral valve replacement carries a risk of left ventricular outflow tract obstruction associated with mortality. We present a case of left ventricular outflow tract obstruction that resolved spontaneously when chords to the anterior mitral leaflet were found to have ruptured. (Level of Difficulty: Advanced.).
| S-EPMC8642730 | biostudies-literature
Project description:Purpose of reviewWe aimed to picture the contemporary landscape of available catheter-based repair and replacement solutions for mitral regurgitation (MR) in Europe.Recent findingsEdge-to-edge repair remains the dominant technique for transcatheter mitral valve repair especially in the context of secondary mitral regurgitation. Two recent randomized trials reported seemingly contradicting clinical results with transcatheter edge-to-edge repair for patients with heart failure and severe secondary MR. A proportionality framework related to secondary MR was proposed to help explain inconsistencies but requires further research. (In)Direct annuloplasty primarily aims to correct secondary MR; however, the scientific basis seems less robust. One dedicated transcatheter heart valve has the CE mark for mitral valve replacement but requires transapical access. Balloon-expandable transcatheter aortic valve platforms are emerging for transvenous transseptal mitral replacement in the context of mitral annular calcification, a failing surgical mitral bioprosthesis, or annuloplasty. Advanced computed tomography imaging techniques improved pre-procedural planning and introduced the option for modeling and simulation. Development of a toolbox of catheter-based technologies, complementary imaging modalities, and refined patient selection offer novel perspectives to high-risk patients with primary or secondary MR. Clinical trials are required to help formulate evidence-based guidelines for the management of mitral valve disease.
| S-EPMC8285321 | biostudies-literature