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. 2022 Apr;163(4):1319-1327.e1.
doi: 10.1016/j.jtcvs.2020.05.049. Epub 2020 May 31.

Multiple MitraClips: The balancing act between pressure gradient and regurgitation

Shelley Chee-Mei Gooden  1 , Hoda Hatoum  1 , Wei Zhang  2 , Konstantinos Dean Boudoulas  3 , Lakshmi Prasad Dasi  4
Affiliations

Multiple MitraClips: The balancing act between pressure gradient and regurgitation

Shelley Chee-Mei Gooden et al. J Thorac Cardiovasc Surg. 2022 Apr.

Abstract

Objective: Transcatheter mitral valve repair with the MitraClip is used for the symptomatic management of mitral regurgitation (MR). The challenge is reducing MR while avoiding an elevated mitral valve gradient (MVG). This study assesses how multiple MitraClips used to treat MR can affect valve performance.

Methods: Six porcine mitral valves were assessed using an in vitro left heart simulator in the native, moderate-to-severe MR, and severe MR cases. MR cases were tested in the no-MitraClip, 1-MitraClip, and 2-MitraClip configurations. Mitral regurgitant fraction (MRF), MVG, and effective orifice area (EOA) were quantified.

Results: Native MRF, MVG, and EOA were 14.22%, 2.59 mm Hg, and 1.64 cm2, respectively. For moderate-to-severe MR, MRF, MVG, and EOA were 34.07%, 3.31 mm Hg, and 2.22 cm2, respectively. Compared with the no-MitraClip case, 1 MitraClip decreased MRF to 18.57% (P < .0001) and EOA to 1.50 cm2 (P = .0002). MVG remained statistically unchanged (3.44 mm Hg). Two MitraClips decreased MRF to 14.26% (P < .0001) and EOA to 1.36 cm2 (P = .0001). MVG remained unchanged (3.29 mm Hg). For severe MR, MRF, MVG, and EOA were 59.79%, 4.98 mm Hg, and 2.73 cm2, respectively. Compared with the no-MitraClip case, 1 MitraClip decreased MRF to 30.72% (P < .0001) and EOA to 1.82 cm2 (P < .0001); MVG remained unchanged (4.03 mm Hg). MVG remained statistically unchanged. Two MitraClips decreased MRF to 23.10% (P < .0001) and EOA to 1.58 cm2 (P < .0001); MVG remained statistically unchanged (3.82 mm Hg). Both MR models yielded no statistical difference between 1 and 2 MitraClips.

Conclusions: There is limited concern regarding elevation of MVG when reducing MR using 1 or 2 MitraClips, although 2 MitraClips did not significantly continue to reduce MRF.

Keywords: MitraClip; PIV; double orifice; mitral regurgitation; mitral valve; ventricular flow.

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Conflict of interest statement

Conflict of Interest: L.P. Dasi reports having patent applications filed on novel polymeric valves, vortex generators and superhydrophobic/omniphobic surfaces. The other authors report no conflicts.

Figures

Figure 1:
Figure 1:
Porcine Mitral Valve Preparation. (A) The heart is first cut open to access the mitral valve. (B) The valve is removed from the heart (top left), and a template of the annulus is created (top right) to customize the mounting plate (bottom left) and accommodating gasket (bottom right). (C) The valve is sutured to the annulus plate, and commissure-to-commissure (CC) and septolateral (SL) dimensions are noted. (D) and (E) An attachment piece is sutured to each papillary muscle for fixation to the papillary control mechanism.
Figure 2:
Figure 2:
Chordal cutting for the MR Model. (A) Chordae connecting the papillary muscles to the P2 scallop are cut to induce MR. (B) Severed chordae can be seen at the newly free edge of the leaflet.
Figure 3:
Figure 3:
Abbott’s MitraClip NT. (A) Opened MitraClip. (B) and (C) Front and side views of the MitraClip with measured dimensions. Central MitraClip placement for one (D) and two (E) MitraClips.
Figure 4:
Figure 4:
Schematic of the left heart simulator.
Figure 5:
Figure 5:
Mitral Valve Mounting. (A) Mounted mitral valve. (B) Mounted mitral valve, highlighting papillary muscle fixation to the papillary muscle control rods. (C) Full view of mounted mitral valve. (D) and (E) Papillary muscle control rods are used to fix the papillary muscles, allowing control of placement in the apical/basal, anterior/posterior, and septal/lateral directions.
Figure 6:
Figure 6:
Hemodynamic Data. Box and whisker plots: (A) MRF – mitral regurgitant fraction, (B) MVG – mitral valve gradient, (C) EOA – effective orifice area. Bar graphs: (D) MRF, (E) MVG, (F) EOA; error bars represent standard deviation. Mod-sev: Moderate-to-severe MR. MC: MitraClip. * p<0.0001 compared to native; § p=0.0002 compared to native; ‡ p<0.0001 compared to unclipped within the same MR grade; # p=0.0001 compared to unclipped within the same MR grade; † p=0.0002 compared to unclipped within the same MR grade.
Figure 7:
Figure 7:
The effect of MitraClip on balancing regurgitation with transmitral pressure gradient.
Central Picture
Central Picture
There is limited concern for elevated mitral valve gradient when using 1 or 2 MitraClips.
See this image and copyright information in PMC

Comment in

  • Commentary: Between Scylla and Charybdis.
    Denti P, Buzzatti N, Alfieri O. Denti P, et al. J Thorac Cardiovasc Surg. 2022 Apr;163(4):1331-1332. doi: 10.1016/j.jtcvs.2020.06.031. Epub 2020 Jun 27. J Thorac Cardiovasc Surg. 2022. PMID: 32680637 No abstract available.
  • Commentary: The importance of annulus in percutaneous mitral valve repair.
    Miceli A, Moneta AA, Donatelli F, Glauber M. Miceli A, et al. J Thorac Cardiovasc Surg. 2022 Apr;163(4):1329-1330. doi: 10.1016/j.jtcvs.2020.06.056. Epub 2020 Jun 28. J Thorac Cardiovasc Surg. 2022. PMID: 32711993 No abstract available.
  • Commentary: The good, the bad, and the ugly.
    Umana JP, Cabrales J. Umana JP, et al. J Thorac Cardiovasc Surg. 2022 Apr;163(4):1328-1329. doi: 10.1016/j.jtcvs.2020.06.104. Epub 2020 Jul 13. J Thorac Cardiovasc Surg. 2022. PMID: 32807559 No abstract available.

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