Current MitraClip experience, safety and feasibility in the Netherlands

Rahhab, Zouhair; Kortlandt, Friso; Velu, Juliëtte F.; Schurer, Remco A. J.; Delgado, Victoria; Tonino, Pim A.L.; Boven, Ad J. van; Branden, Ben J L Van den; Kraaijeveld, Adriaan O.; Voskuil, Michiel; Hoorntje, Jan C.A.; Wely, Marleen van; Houwelingen, K. van; Bleeker, Gabe B.; Rensing, Benno J.; Kardys, Isabella; Baan, Jan; Heyden, Jan A.S. Van der; Mieghem, Nicolas Van

doi:10.1007/s12471-017-0992-1

Cited by 10 publications

(6 citation statements)

References 17 publications

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“…With the recently introduced larger MitraClip XTR device, improved intraprocedural coaptation in severe FMR cases should be obtainable. Another aspect potentially limiting the applicability of our study results to current TMVR therapy is the use of 1.1 clips compared with a mean of 1.5 or 1.7 clips per procedure reported by others, 28,39 thus reflecting a learning curve in the field of TMVR therapy (i.e., larger numbers of implanted clips and less restrictive selection of patients according to the EVEREST criteria).…”

Section: Limitationsmentioning

confidence: 72%

Recurrence of Functional Versus Organic Mitral Regurgitation After Transcatheter Mitral Valve Repair: Implications from Three-Dimensional Echocardiographic Analysis of Mitral Valve Geometry and Left Ventricular Dilation for a Point of No Return

Buck

Eiswirth

Farah

et al. 2021

Journal of the American Society of Echocardiography

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Background: MitraClip implantation has become the standard transcatheter mitral valve repair (TMVR) technique for severe mitral regurgitation (MR). However, approximately one third of patients have poor outcomes, with MR recurrence at follow-up. The aim of this study was to investigate whether quantitative analysis of mitral valve (MV) geometry on three-dimensional (3D) echocardiography can identify geometric parameters associated with the recurrence of severe functional MR (FMR) versus organic MR (OMR) at 6-month follow-up after TMVR using the MitraClip.Methods: Sixty-one patients with severe FMR (n = 45) or OMR (n = 16) who underwent transesophageal 3D echocardiography before and 6 months after TMVR were retrospectively analyzed. MV geometry was quantified using 3D echocardiography software. Vena contracta area (VCA) at 6-month follow-up was used to define two outcome groups: patients with good results with VCA < 0.6 cm 2 (MR < 0.6) and those with MR recurrence with VCA $ 0.6 cm 2 (MR $ 0.6).Results: MR recurrence was found in 34% of all study patients (21 of 61). In patients with FMR, significant differences between MR < 0.6 and MR $ 0.6 were found at baseline for tenting index (1.13 vs 1.23, P = .004), tenting volume (2.8 vs 4.0 ml, P = .04), indexed left ventricular (LV) end-diastolic volume (68.0 vs 99.9 ml/m 2 , P = .001), and VCA (0.71 vs 1.00 cm 2 , P = .003); no significant parameters of MR recurrence were found in patients with OMR. Multivariate analysis identified indexed LV enddiastolic volume as the strongest independent determinant of MR recurrence. Receiver operating characteristic analysis identified a tenting index of 1.185 (area under the curve 0.79) and indexed LV end-diastolic volume of 88 ml/m 2 (area under the curve 0.76) to best discriminate between MR < 0.6 and MR $ 0.6.Conclusions: MR recurrence after TMVR in patients with FMR is associated with advanced LV dilation and MV tenting before TMVR, which provides clinical implications for a point of no return beyond which progressive LV dilation with MV geometry dilation and tethering cannot be effectively prevented by TMVR. In contrast, no significant determinants of MR recurrence and progressive MV annular dilation could be identified in patients with OMR.

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Section: Limitationsmentioning

confidence: 72%

Recurrence of Functional Versus Organic Mitral Regurgitation After Transcatheter Mitral Valve Repair: Implications from Three-Dimensional Echocardiographic Analysis of Mitral Valve Geometry and Left Ventricular Dilation for a Point of No Return

Buck

Eiswirth

Farah

et al. 2021

Journal of the American Society of Echocardiography

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“…The reason for this discrepancy is most likely the increasing experience and practice with the MitraClip system since its introduction, leading to more targeted deployment of fluoroscopy and reduced fluoroscopy time. Likewise, a registry study reported that device time substantially decreased since the emergence of percutaneous mitral valve repair 13 . Thus, although derived from a single‐center study, our findings might best represent the actual radiation exposure in contemporary use of MitraClip implantation.…”

Section: Discussionmentioning

confidence: 87%

“…After introduction of the low dose protocol, radiation dose area product dropped from 2265 to 693 [366-1231] cGy•cm 2 (p < 0.001, Table 2 and Figure 3). Concurrently, fluoroscopy time decreased from 25 to 17 [13][14][15][16][17][18][19][20][21][22][23] min (p = 0.02). Dose area product per fluoroscopy time also strongly decreased from 110 [80-140] to 38 cGy•cm 2 /min (p < 0.001), reflecting the adjustments in X-ray settings.…”

Section: Radiation Exposure and Procedural Outcomementioning

confidence: 99%

Reduction of radiation exposure during transcatheter edge‐to‐edge mitral valve repair

Paulus

Meindl

Hamerle

et al. 2022

Cathet Cardio Intervent

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Background: Transcatheter mitral valve repair is an increasingly used therapy for mitral regurgitation which requires fluoroscopic guidance. Limiting radiation exposure during lengthy procedures is important for both patient and operator safety.This study aimed to investigate radiation dose during contemporary use of MitraClip implantation and the effects of a dose reduction program. Methods: A total of 115 patients who underwent MitraClip implantation were prospectively enrolled in a single-center observational study. During the inclusion period, our institution adopted a radiation dose reduction program, comprising lowering of fluoroscopy pulse rate and image target dose. The first 58 patients were treated with conventional fluoroscopy settings, while the following 57 patients underwent the procedure with the newly implemented low dose protocol. Results: Radiation dose area product significantly decreased after introduction of the low dose protocol (693 [366-1231] vs. 2265 [1517-3914] cGy•cm 2 , p < 0.001).After correcting for fluoroscopy time, gender and body mass index, the low dose protocol emerged as a strong negative predictor of radiation dose (p < 0.001), reducing dose area product by 64% (95% confidence interval [57][58][59][60][61][62][63][64][65][66][67][68][69][70]). Device time, device success, and procedural safety did not differ between the normal dose and low dose group. Furthermore, the low dose protocol was not associated with an increased incidence of a combined endpoint consisting of death, repeat intervention, or heart surgery during 12 months follow-up. Conclusion:Reduction of radiation exposure during transcatheter mitral valve repair by 64% is feasible without affecting procedural success or safety.

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“…Additionally, the first-in-man experience with the PASCAL MV repair system (Edwards Lifesciences, Irvine, CA, USA) has recently been reported and showed a consistent reduction in MR severity following percutaneous E-to-E repair [ 9 ]. Moreover, recent clinical data suggests that transcatheter E-to-E repair is an effective strategy for treating MR and is well tolerated in select high risk patients [ 10 , 11 ].…”

Section: Introductionmentioning

confidence: 99%

Effect of Edge-to-Edge Mitral Valve Repair on Chordal Strain: Fluid-Structure Interaction Simulations

Toma

Einstein

Kohli

et al. 2020

Biology

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Edge-to-edge repair for mitral valve regurgitation is being increasingly performed in high-surgical risk patients using minimally invasive mitral clipping devices. Known procedural complications include chordal rupture and mitral leaflet perforation. Hence, it is important to quantitatively evaluate the effect of edge-to-edge repair on chordal integrity. in this study, we employ a computational mitral valve model to simulate functional mitral regurgitation (FMR) by creating papillary muscle displacement. Edge-to-edge repair is then modeled by simulated coaptation of the mid portion of the mitral leaflets. in the setting of simulated FMR, edge-to-edge repair was shown to sustain low regurgitant orifice area, until a two fold increase in the inter-papillary muscle distance as compared to the normal mitral valve. Strain in the chordae was evaluated near the papillary muscles and the leaflets. Following edge-to-edge repair, strain near the papillary muscles did not significantly change relative to the unrepaired valve, while strain near the leaflets increased significantly relative to the unrepaired valve. These data demonstrate the potential for computational simulations to aid in the pre-procedural evaluation of possible complications such as chordal rupture and leaflet perforation following percutaneous edge-to-edge repair.

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Current MitraClip experience, safety and feasibility in the Netherlands

Cited by 10 publications

References 17 publications

Recurrence of Functional Versus Organic Mitral Regurgitation After Transcatheter Mitral Valve Repair: Implications from Three-Dimensional Echocardiographic Analysis of Mitral Valve Geometry and Left Ventricular Dilation for a Point of No Return

Recurrence of Functional Versus Organic Mitral Regurgitation After Transcatheter Mitral Valve Repair: Implications from Three-Dimensional Echocardiographic Analysis of Mitral Valve Geometry and Left Ventricular Dilation for a Point of No Return

Reduction of radiation exposure during transcatheter edge‐to‐edge mitral valve repair

Effect of Edge-to-Edge Mitral Valve Repair on Chordal Strain: Fluid-Structure Interaction Simulations

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