Semirigid posterior annuloplasty band: Reshaping the mitral orifice while preserving its physiology.
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ABSTRACT:
SUBMITTER: James L
PROVIDER: S-EPMC8691863 | biostudies-literature | 2021 Dec
REPOSITORIES: biostudies-literature
Publications
Semirigid posterior annuloplasty band: Reshaping the mitral orifice while preserving its physiology.
James Les L Grossi Eugene A EA Loulmet Didier F DF Galloway Aubrey C AC
JTCVS techniques 20211007
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Project description:ObjectiveThe study objective was to develop a novel annuloplasty ring with regional flexibility and assess its suture force dynamics in healthy ovine subjects compared with fully rigid or fully flexible rings.MethodsMaterially heterogeneous rings were created with rigid anterior and posterior, and flexible commissural segments. These rings were created to match the geometry of the Profile 3D ring (Medtronic, Minneapolis, Minn). Each ring was instrumented with 10 force transducers to measure cyclic suture forces (FC) and undersized annuloplasty was performed in 6 healthy ovine subjects. Each FC was recorded and examined for cardiac cycles reaching a maximum left ventricular pressure of 100, 125, and 150 mm Hg. FC was compared with previously reported values from fully rigid Profile 3D and fully flexible prototype rings.ResultsRelative to the fully rigid ring, the heterogeneous ring exhibited 48% reduction in FC at its commissural (rigid vs heterogeneous: 1.80 ± 0.94 N vs 0.95 ± 0.52 N; P < .001) and 32% reduction in posterior (1.90 ± 0.92 N vs 1.29 ± 0.91 N; P < .001) regions, but not in its anterior region (2.45 ± 1.21 N vs 2.23 ± 1.22 N; P = .279). Relative to the fully flexible ring, the heterogeneous ring exhibited no significant differences in FC in any region.ConclusionsThe reduced FC of the heterogeneous ring relative to the fully rigid ring suggests a promising approach to reduce suture loading while preserving the annular remodeling capability of fully rigid rings. Future studies in diseased subjects are necessary to explore repair effectiveness of this ring.
| S-EPMC6885108 | biostudies-literature
Project description:ObjectivesThe clinical importance of optimal post-repair mitral valve diastolic performance is increasingly being recognized. The haemodynamic effect of a partial annuloplasty band implantation, in comparison to a full ring, remains insufficiently explored.MethodsPatients undergoing mitral valve repair for pure degenerative disease between 2011 and 2019 at 2 experienced heart valve centres were eligible for inclusion. Exclusion criteria were concomitant procedures other than tricuspid valve repair and ablation procedures for atrial fibrillation. Pre-discharge and follow-up echocardiograms (1-4 years after surgery) were analysed to assess haemodynamic mitral valve performance.ResultsOf 535 patients meeting the inclusion criteria, 364 (68.0%) patients underwent full annuloplasty ring and 171 (31.0%) partial band implantation. On predischarge echocardiogram, post-repair mitral valve gradient and area did not differ between groups [2.89 mmHg (IQR 2.26-3.72) vs 2.60 mmHg (IQR 1.91-3.55), P = 0.19 and 1.98 cm2 (IQR 1.66-2.46) vs 2.03 cm2 (IQR 1.55-3.06), P = 0.15]. However, multivariable linear regression analysis demonstrated band annuloplasty as a determinant of larger valve area (coefficient 0.467 cm2, standard error 0.105, P < 0.001). On multivariable analysis, no significant impact on post-repair gradient was observed (-0.370 mmHg, standard error 0.167, P = 0.36). At follow-up, the differences between groups disappeared and multivariable regression analysis failed to demonstrate a significant impact of annuloplasty device type on mitral valve gradient (coefficient -0.095 mmHg, standard error 0.171, P = 1.00) or area (coefficient -0.085 cm2, standard error 0.120, P = 1.00). These results were confirmed with a linear mixed model analysis.ConclusionsPartial band annuloplasty was related to an improved haemodynamic profile directly after valve repair for degenerative disease but the effect was short-lived. Our results suggest that the type of annuloplasty device has no durable impact on diastolic valve performance.
| S-EPMC10517645 | biostudies-literature
Project description: Not available
| S-EPMC9366867 | biostudies-literature
Project description:Patients with functional, or secondary, mitral regurgitation (FMR, SMR) often face significant symptoms that lead to functional decline as well as hospitalization and even death. Traditional mitral annuloplasty is an important treatment option for patients with FMR, but surgical risk and durability are important limitations. Percutaneous strategies are therefore a welcome alternative. The Carillon device utilizes the relationship of the coronary sinus and the mitral annulus to effect an "indirect" annuloplasty. Early series' and recent randomized trials suggest echocardiographic and clinical benefit with a relatively straight-forward implantation technique and low rate of significant complications.
| S-EPMC7715026 | biostudies-literature
Project description:Background and aimsThe main pathophysiological factor of chronic ischemic mitral regurgitation (MR) is the outward displacement of the papillary muscles (PMs) leading to leaflet tethering. For this reason, papillary muscle intervention (PMI) in combination with mitral ring annuloplasty (MRA) has recently been introduced into clinical practice to correct this displacement, and to reduce the recurrence of regurgitation.MethodsA meta-analysis was conducted comparing the outcomes of PMI and MRA performed in combination vs MRA performed alone, in terms of MR recurrence and left ventricular reverse remodeling (LVRR). A meta-regression was carried out to investigate the impact of the type of PMI procedure on the outcomes.ResultsMR recurrence in patients undergoing both PMI and MRA was lower than in those who only had MRA (log incidence rate ratio, -0.66; lower-upper limits, -1.13 to 0.20; I2 = 0.0%; p = .44; Egger's test: intercept 0.35 [-0.78 to 1.51]; p = .42). The group with both PMI and MRA and that with only MRA showed a slightly higher reduction in left ventricular diameters (-5.94%; -8.75% to 3.13%,). However, in both groups, LVRR was <10%. No difference was detected between PM relocation/repositioning and papillary muscle approximation in terms of LVRR (p = .33).ConclusionsUsing PMI and MRA together has a lower MR recurrence than using MRA alone. No significant LVRR was observed between the two groups nor between the PMI techniques employed.
| S-EPMC7078820 | biostudies-literature
Project description:Mitral valve regurgitation (MR) is a common valvular heart disease where an improper closure leads to leakage from the left ventricle into the left atrium. There is a need for less-invasive treatments such as percutaneous repairs for a large inoperable patient population. The aim of this study is to compare several indirect mitral annuloplasty (IMA) percutaneous repair techniques by finite-element analyses. Two types of generic IMA devices were considered, based on coronary sinus vein shortening (IMA-CS) to reduce the annulus perimeter and based on shortening of the anterior-posterior diameter (IMA-AP). The disease, its treatments, and the heart function post-repair were modelled by modifying the living heart human model (Dassault Systèmes). A functional MR pathology that represents ischaemic MR was generated and the IMA treatments were simulated in it, followed by heart function simulations with the devices and leakage quantification from blood flow simulations. All treatments were able to reduce leakage, the IMA-AP device achieved better sealing, and there was a correlation between the IMA-CS device length and the reduction in leakage. The results of this study can help in bringing IMA-AP to market, expanding the use of IMA devices, and optimizing future designs of such devices.
| S-EPMC8753151 | biostudies-literature
Project description:OBJECTIVES:Pledget-assisted suture tricuspid valve annuloplasty (PASTA) is a novel technique using marketed equipment to deliver percutaneous trans-annular sutures to create a double-orifice tricuspid valve. BACKGROUND:Tricuspid regurgitation is a malignant disease with high surgical mortality and no commercially available transcatheter solution in the US. METHODS:Two iterations of PASTA were tested using trans-apical or trans-jugular access in swine. Catheters directed paired coronary guidewires to septal and lateral targets on the tricuspid annulus under fluoroscopic and echocardiographic guidance. Guidewires were electrified to traverse the annular targets and exchanged for pledgeted sutures. The sutures were drawn together and knotted, apposing septal and lateral targets, creating a double orifice tricuspid valve. RESULTS:Twenty-two pigs underwent PASTA. Annular and chamber dimensions were reduced (annular area, 10.1 ± 0.8 cm2 to 3.8 ± 1.5 cm2 (naïve) and 13.1 ± 1.5 cm2 to 6.2 ± 1.0 cm2 (diseased); septal-lateral diameter, 3.9 ± 0.3 mm to 1.4 ± 0.6 mm (naïve) and 4.4 ± 0.4 mm to 1.7 ± 1.0 mm (diseased); and right ventricular end-diastolic volume, 94 ± 13 ml to 85 ± 14 ml (naïve) and 157 ± 25 ml to 143 ± 20 ml (diseased)). MRI derived tricuspid regurgitation fraction fell from 32 ± 12% to 4 ± 5%. Results were sustained at 30 days. Pledget pull-through force was five-fold higher (40.6 ± 11.7N vs 8.0 ± 2.6N, P < .01) using this strategy compared to single puncture techniques used to anchor current investigational devices. Serious complications were related to apical access. CONCLUSIONS:PASTA reduces annular dimensions and tricuspid regurgitation in pigs. It may be cautiously applied to selected patients with severe tricuspid regurgitation and no options. This is the first transcatheter procedure, to our knowledge, to deliver standard pledgeted sutures to repair cardiac pathology.
| S-EPMC6078835 | 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 define the effects of annuloplasty rings (ARs) on the dynamic motion of anterior mitral leaflet (AML) and posterior mitral leaflet (PML).Fifty-eight adult, Dorsett-hybrid, male sheep (49 + or - 5 kg) had radiopaque markers inserted: eight around the mitral annulus, four along the central meridian (from edge to annulus) of the AML (#A(1)-#A(4)) and one on the PML edge (#P(1)). True-sized Edwards Cosgrove (COS, n=12), St Jude RSAR (St. Jude Medical, St. Paul, MN, USA) (n=12), Carpentier-Edwards Physio (PHYSIO, n=12), Edwards IMR ETlogix (ETL, n=10) or Edwards GeoForm (GEO, n=12) ARs were implanted in a releasable fashion. Under acute open-chest conditions, 4D marker coordinates were obtained using biplane videofluoroscopy with the respective AR inserted (COS, RSAR, PHYSIO, ETL and GEO) and after release (COS-Control, RSAR-Control, PHYSIO-Control, ETL-Control and GEO-Control). AML and PML excursions were calculated as the difference between minimum and maximum angles between the central mitral annular septal-lateral chord and the AML edge markers (alpha(1exc)-alpha(4exc)) and PML edge marker (beta(1exc)) during the cardiac cycle.Relative to Control, (1) RSAR, PHYSIO, ETL and GEO increased excursion of the AML annular (alpha(4exc): 13 + or - 6 degrees vs 16 + or - 7 degrees *, 16 + or - 7 degrees vs 23 + or - 10 degrees *, 12 + or - 4 degrees vs 18 + or - 9 degrees *, 15 + or - 1 degrees vs 20 + or - 9 degrees *, respectively) and belly region (alpha(2exc): 41 + or - 10 degrees vs 45 + or - 10 degrees *, 42 + or - 8 degrees vs 45 + or - 6 degrees , n.s., 33 + or - 13 degrees vs 42 + or - 14 degrees *, 39 + or - 6 degrees vs 44 + or - 6 degrees *, respectively, alpha(3exc): 24 + or - 9 degrees vs 29 + or - 11 degrees *, 28 + or - 10 degrees vs 33 + or - 10 degrees *, 16 + or - 9 degrees vs 21 + or - 12 degrees *, 25 + or - 7 degrees vs 29 + or - 9 degrees *, respectively), but not of the AML edge (alpha(1exc): 42 + or - 8 degrees vs 44 + or - 8 degrees , 43 + or - 8 degrees vs 41 + or - 6 degrees , 42 + or - 11 vs 46 + or - 10 degrees , 39 + or - 9 degrees vs 38 + or - 8 degrees , respectively, all n.s.). COS did not affect AML excursion (alpha(1exc): 40 + or - 8 degrees vs 37 + or - 8 degrees , alpha(2exc): 43 + or - 9 degrees vs 41 + or - 9 degrees , alpha(3exc): 27 + or - 11 degrees vs 27 + or - 10 degrees , alpha(4exc): 18 + or - 8 degrees vs 17 + or - 7 degrees , all n.s.). (2) PML excursion (beta(1exc)) was reduced with GEO (53 + or - 5 degrees vs 43 + or - 6 degrees *), but unchanged with COS, RSAR, PHYSIO or ETL (53 + or - 13 degrees vs 52 + or - 15 degrees , 50 + or - 13 degrees vs 49 + or - 10 degrees , 55 + or - 5 degrees vs 55 + or - 7 degrees , 52 + or - 8 degrees vs 58 + or - 6 degrees , respectively, all n.s); *=p<0.05.RSAR, PHYSIO, ETL and GEO rings, but not COS, increase AML excursion of the AML annular and belly region, suggesting higher anterior mitral leaflet bending stresses with rigid rings, which potentially could be deleterious with respect to repair durability. The decreased PML excursion observed with GEO could impair left ventricular filling. Clinical studies are needed to validate these findings in patients.
| S-EPMC2913157 | biostudies-literature
Project description: Not available
| S-EPMC10695758 | biostudies-literature