Implantation of a MitraClip between two previously implanted MitraClips to treat recurrent severe mitral regurgitation

Abstract

We first describe the implantation of a MitraClip (Abbott Vascular, Abbott Park, IL, USA) between 2 previously implanted MitraClips to treat recurrent mitral regurgitation (MR). An 82-year-old male patient presented with dyspnea New York Heart Association NYHA class III due to recurrent severe MR 18 months after primarily successful implantation of 2 MitraClips. The initial procedure was performed to treat severe MR due to prolapse and flail of the anterior leaflet and resulted in mild MR after implantation of 2 MitraClips. Concomitant diseases were persistent atrial fibrillation, moderate tricuspid valve regurgitation, and chronic kidney disease stage 3. Thus, the patient was not considered a suitable candidate for surgical treatment. Using fluoroscopic guidance, 2D- and 3D-transesophageal echocardiographies, we succeeded in placing a third clip between the previously implanted clips and reduced the severe MR to mild MR without increase in the mean gradient. No periprocedural complications were observed. Six months after the procedure the patient presented with mild MR and NYHA class I.

<Learning objective: Implantation of MitraClips offers the possibility of percutaneous mitral valve repair. It is feasible, safe, and effective to implant a 3rd MitraClip between 2 previously implanted MitraClips to treat recurrent mitral regurgitation between the clips.>

Introduction

Transcatheter edge-to-edge mitral valve repair (TMVR) applying the MitraClip System (Abbott Vascular, Abbott Park, IL, USA) is the most established, interventional technique for treating mitral valve regurgitation (MR) in high-risk patients not amenable to surgery and widely-used in Western Europe. In several studies it was proven feasible, effective, and safe in selected patients both for primary and secondary MR [1]. However, in some patients MR may reappear during follow-up [2]. Thus, treatment of recurrent MR after MitraClip will increasingly become important.

Case report

An 82-year-old male presented at our hospital with dyspnea New York Heart Association (NYHA) III and severe MR as well as preserved left ventricular ejection fraction (LVEF by Simpson method 56%) and left ventricular endsystolic diameter (LVESD) of 33 mm. Moreover, he had a clinical history of persistent atrial fibrillation, moderate tricuspid valve regurgitation, and chronic kidney disease stage-3 resulting in a logistic EUROScore of 6.61% and a STS Risk Score of 8.75%. Under optimal medical therapy with 5 mg ramipril, 5 mg bisoprolol, and 10 mg torasemid systolic blood pressure was 110 mmHg. Owing to frailty and age, the heart team judged the patient at high risk for surgery and, therefore, decided on percutaneous therapy using the MitraClip. The pathology of the mitral valve was complex with a severe prolapse of the anterior mitral valve leaflet (AML) and a flail gap of 0.24 cm mainly in A1/transition to A2-segment, since localization was not central it did not meet the EVEREST inclusion criteria [3].

The initial result after implantation of 2 MitraClips (first clip placed centrally in A2 and second clip lateral to the first clip in A2/A1-segment) was excellent with a MR reduction to grade < I [proximal isovelocity surface area (PISA) 3 mm with 31 cm/s, effective regurgitant orifice area (EROA) 0.05 cm², MR volume 6 ml] from grade III (PISA 9 mm with 33 cm/s, EROA 0.38 cm², MR volume 52 ml, Suppl. Fig. 1A and B). The mean gradient was 1 mmHg before clipping and increased to 2 mmHg after implantation of the 2 clips. Eighteen months afterwards, the patient presented again with progressive dyspnea NYHA III. LVEF was 57% and LVESD increased to 38 mm. Transesophageal echocardiography (TEE) revealed proper position of the leaflets within the clips. However, the lateral clip displayed a lifting of the AML due to the previously described severe prolapse with flail, resulting in a recurrent MR grade III (PISA-radius 8 mm with 31 cm/s, EROA 0.3 cm², MR volume 41 mm, Suppl. Fig. 1C) with the main jet originating between both clips and running eccentrically and postero-laterally to the roof of the left atrium. Since there was no mitral stenosis (mean gradient 1 mmHg) we considered a second TMVR. The anatomical presuppositions with a tight gap between the prior implanted clips were challenging since the clip width per se is 5 mm (Fig. 1) and the distance between the two MitraClips measured with QLAB (Philips, Amsterdam, The Netherlands) revealed a distance of 6–8 mm (Fig. 2).

Fig. 1.

MitraClip device dimensions.

Fig. 2.

QLAB-measurement of the distance between the two already implanted clips.

Supplementary material related to this article can be found, in the online version, at http://dx.doi.org/10.1016/j.jccase.2016.10.009.

Supplementary Fig. 1.

Transesophageal echocardiographic images of the mitral valve before and after the 1st as well as the 2nd MitraClip procedure (A–D).

After transseptal access through the previous puncture site using fluoroscopic guidance, 2D and 3D-TEE (Fig. 3) we succeeded in placing a third clip between the previously implanted clips. The leaflet grasping could not be sufficiently evaluated by TEE due to noise artifacts. However with color-Doppler no residual ‘intra-clip’ MR was noticeable. In fluoroscopy one could distinguish an upward shift and movement of the clips toward one another as indirect signs of good leaflet grasping (Suppl. Movie 1). After release of the clip, MR was mild (PISA 4 mm at 31 cm/s, EROA 0.08 cm², MR volume 10 ml, Suppl. Fig. 1D) with no increase in the mean gradient (Suppl. Fig. 2A). The entire X-ray time of the procedure was 35.2 min with a dose-area product 6483 mGy cm². No periprocedural complications occurred, and the patient was discharged 5 days after the procedure.

Fig. 3.

Fluoroscopic guidance: (A) insertion of the clip between the previously implanted 2 clips, (B) before grasping the leaflets, (C) after grasping the leaflets, (D) release of the clip.

Supplementary material related to this article can be found, in the online version, at http://dx.doi.org/10.1016/j.jccase.2016.10.009.

Supplementary Movie 1

Release of the 3rd clip and movement of the 3 clips toward one another.

Supplementary Fig. 2.

(A) Echocardiographic image of the transvalvular mitral gradient direct after implantation of the 3rd clip (measured by transesophageal echocardiography); (B) echocardiographic image of the transvalvular mitral gradient after implantation of the 3rd MitraClip at 6-month follow-up (measured by transthoracic echocardiography).

Six months after the second TMVR the patient remained oligosymptomatic (NYHA I) and MR was grade I without signs for mitral stenosis by transthoracic echocardiography (PISA 3 mm at 31 cm/s, EROA 0.05 cm², MR volume 6 ml, mean gradient 3 mmHg, Suppl. Fig. 2B).

Discussion

TMVR applying the MitraClip System is the most established, interventional technique for treating MR in high-risk patients not amenable to surgery and widely-used in Western Europe [1]. In several studies it was proven feasible, effective, and safe in selected patients both for primary and secondary MR [1]. The outcome after TMVR is influenced by several anatomic and patient characteristics. In the randomized EVEREST (Endovascular Valve Edge-to-Edge Repair Study) II trial the anatomic inclusion criteria were stringent, and numerous patients – as our patient – treated in current clinical practice do not qualify according to the EVEREST II inclusion criteria [3]. However, in everyday clinical practice numerous patients are treated with minimal-invasive transcatheter approaches, in whom anatomically ideal criteria for TMVR do not match. Recommendations for patient selection with ideal, intermediate, or unsuitable anatomic criteria for TMVR have been published, which are also considered as prognostic factors for acute procedural success. Previous studies have shown that especially in primary MR often more than one clip per procedure is needed. There are some case reports presenting treatment strategies with ‘multiple-clip-placements’ or ‘zipping-by-clipping’ [4], [5], [6]. Another report even described successful treatment of residual ‘intra-clip’ MR with an Amplatzer Vascular Plug II [7].

In this case, we demonstrate that it is feasible to implant a third clip between two MitraClips for recurrent, severe ‘intra-clip’ MR although it is technically challenging. Recurrence of MR in our case might be due to the residual lifting of the prolapsing AML as well as partial leaflet detachment of the medial part of the AML – although the lateral part of the AML was still attached to the lateral (secondly implanted) MitraClip as the underlying cause for the flail between the 2 clips with subsequent MR. Retrospectively implantation of a 3rd clip at the 1st session in order to stabilize the other clips and leaflet movements might have been an option. In consideration of the fact that most of the patients treated with TMVR are high-risk patients and not amenable to surgery it may become an important issue – especially in secondary MR. Particularly the left ventricular dilation might progress over the years and thus could cause further mitral annulus dilation. As a result, the initial successful ‘zipping’ or ‘multiple-clip’ strategy might display with a recurrent ‘intra-clip’ MR. Therefore it is necessary to advance the development of the minimal invasive therapy options since a combination of a percutaneous mitral valve annuloplasty with the percutaneous edge-to-edge repair seems to be promising in such patients. The present case demonstrates the feasibility of implantation of a 3rd MitraClip between 2 previously implanted MitraClips to treat recurrent MR between the clips.

Conflict of interest statement

D. Breuer is an employee at Abbott Vascular Structural Heart Germany; A.M. Kasel is proctor physician for Edwards Lifesciences.