Dataset Information

Indirect Mitral Annuloplasty Using the Carillon Device.

ABSTRACT: 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.

SUBMITTER: Krishnaswamy A

PROVIDER: S-EPMC7715026 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Indirect Mitral Annuloplasty Using the Carillon Device.

Krishnaswamy Amar A Kapadia Samir R SR

Frontiers in cardiovascular medicine 20201120

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 "indirec ...[more]

PMID: 33330643

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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.

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.

Dataset Information

Indirect Mitral Annuloplasty Using the Carillon Device.

Publications

Indirect Mitral Annuloplasty Using the Carillon Device.

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