MitraClip-procedure with two Mitra-Clips after indirect anuloplasty with the MONARC-device

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Abstract

Mitral regurgitation is associated with a worsened prognosis in dilated cardiomyopathy. First standard therapy consists of a mitral valve reconstruction through heart surgery including the heart–lung machine. In patients with high comorbidity, catheter-based techniques have been developed. In the Evolution I study, the MONARC system was implanted in the coronary sinus in the functional mitral regurgitation. A reduction in regurgitation by >1 grade was documented in 50% of the patients. MitraClip is an alternative, edge-to-edge technique, which joined the posterior and anterior leaflet by implanting a clip. It can be used for both functional and degenerative mitral regurgitations. We reported a case of MitraClip procedure with the use of two clips and a reduction of mitral regurgitation to grade 0–1 after implanting a MONARC device four years ago with missing relevant reduction in mitral regurgitation. With this report, we illustrated the management of Mitraclip in a patient with an implanted MONARC device and technical difficulties through the bowing of the posterior annulus.

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Percutaneous repair or surgery for mitral regurgitation.

D D Glower, S Fail, Elyse Foster … (2011)

Mitral-valve repair can be accomplished with an investigational procedure that involves the percutaneous implantation of a clip that grasps and approximates the edges of the mitral leaflets at the origin of the regurgitant jet. We randomly assigned 279 patients with moderately severe or severe (grade 3+ or 4+) mitral regurgitation in a 2:1 ratio to undergo either percutaneous repair or conventional surgery for repair or replacement of the mitral valve. The primary composite end point for efficacy was freedom from death, from surgery for mitral-valve dysfunction, and from grade 3+ or 4+ mitral regurgitation at 12 months. The primary safety end point was a composite of major adverse events within 30 days. At 12 months, the rates of the primary end point for efficacy were 55% in the percutaneous-repair group and 73% in the surgery group (P=0.007). The respective rates of the components of the primary end point were as follows: death, 6% in each group; surgery for mitral-valve dysfunction, 20% versus 2%; and grade 3+ or 4+ mitral regurgitation, 21% versus 20%. Major adverse events occurred in 15% of patients in the percutaneous-repair group and 48% of patients in the surgery group at 30 days (P<0.001). At 12 months, both groups had improved left ventricular size, New York Heart Association functional class, and quality-of-life measures, as compared with baseline. Although percutaneous repair was less effective at reducing mitral regurgitation than conventional surgery, the procedure was associated with superior safety and similar improvements in clinical outcomes. (Funded by Abbott Vascular; EVEREST II ClinicalTrials.gov number, NCT00209274.).

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Acute and 12-month results with catheter-based mitral valve leaflet repair: the EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study.

Patrick L Whitlow, Ted Feldman, Wes R. Pedersen … (2012)

The EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study (HRS) assessed the safety and effectiveness of the MitraClip device (Abbott Vascular, Santa Clara, California) in patients with significant mitral regurgitation (MR) at high risk of surgical mortality rate. Patients with severe MR (3 to 4+) at high risk of surgery may benefit from percutaneous mitral leaflet repair, a potentially safer approach to reduce MR. Patients with severe symptomatic MR and an estimated surgical mortality rate of ≥12% were enrolled. A comparator group of patients screened concurrently but not enrolled were identified retrospectively and consented to compare survival in patients treated by standard care. Seventy-eight patients underwent the MitraClip procedure. Their mean age was 77 years, >50% had previous cardiac surgery, and 46 had functional MR and 32 degenerative MR. MitraClip devices were successfully placed in 96% of patients. Protocol-predicted surgical mortality rate in the HRS and concurrent comparator group was 18.2% and 17.4%, respectively, and Society of Thoracic Surgeons calculator estimated mortality rate was 14.2% and 14.9%, respectively. The 30-day procedure-related mortality rate was 7.7% in the HRS and 8.3% in the comparator group (p = NS). The 12-month survival rate was 76% in the HRS and 55% in the concurrent comparator group (p = 0.047). In surviving patients with matched baseline and 12-month data, 78% had an MR grade of ≤2+. Left ventricular end-diastolic volume improved from 172 ml to 140 ml and end-systolic volume improved from 82 ml to 73 ml (both p = 0.001). New York Heart Association functional class improved from III/IV at baseline in 89% to class I/II in 74% (p < 0.0001). Quality of life was improved (Short Form-36 physical component score increased from 32.1 to 36.1 [p = 0.014] and the mental component score from 45.5 to 48.7 [p = 0.065]) at 12 months. The annual rate of hospitalization for congestive heart failure in surviving patients with matched data decreased from 0.59 to 0.32 (p = 0.034). The MitraClip device reduced MR in a majority of patients deemed at high risk of surgery, resulting in improvement in clinical symptoms and significant left ventricular reverse remodeling over 12 months. (Pivotal Study of a Percutaneous Mitral Valve Repair System [EVEREST II]; NCT00209274). Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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The double-orifice technique in mitral valve repair: a simple solution for complex problems.

O Alfieri, John L Stefano, M Oppizzi … (2001)

The aim of this study is to report our results with the central double-orifice technique used for the treatment of complex mitral valve lesions. The central double-orifice repair has been used in 260 patients (mean age, 56 +/- 14.3 years) over a period of 7 years. The mechanism responsible for mitral regurgitation was prolapse of both leaflets in 148 patients, prolapse of the anterior leaflet in 68, prolapse of the posterior leaflet with annular calcification or other unfavorable features in 31, and lack of leaflet coaptation for restricted motion or erosion of the free edge in 13. Degenerative disease was the cause of mitral regurgitation in 80.8% of the patients, rheumatic disease was the cause in 9.6%, endocarditis was the cause in 6.1%, and ischemic disease was the cause in 2.3%. Hospital mortality was 0.7%, and the overall survival at 5 years was 94.4% +/- 2.59%. Thirteen patients required a reoperation (2 early postoperatively and 11 late during the follow-up), for an overall freedom from reoperation of 90.0% +/- 3.37% at 5 years. Freedom from reoperation was lower in patients with rheumatic valve disease and in patients who did not undergo an annuloplasty procedure. The effectiveness and durability of the central double-orifice technique were assessed in this study. This type of repair can be a useful addition to the surgical armamentarium in mitral valve reconstruction.

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Author and article information

Affiliations

Department of Cardiology and Pulmology, Charite, Campus Benjamin Franklin, Hindenburgdamm 30, 12200 Berlin, Germany

Author notes

[* ]Corresponding author's e-mail address: susanne.rutschow@ 123456charite.de

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Susanne Rutschow: (View ORCID Profile)

Journal

Journal ID (publisher-id): SOR-MED

Title: ScienceOpen Research

Publisher: ScienceOpen

ISSN (Electronic): 2199-1006

Publication date: 20 October 2014

Volume: 0 (ID: d0c9107d-0684-4c10-b620-eca9ef5a0600 )

Issue: 0

Pages: 1-3

ID: 1953:XE ID: 10.14293/S2199-1006.1.SORMED.AO7DCV.v1

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This work has been published open access under Creative Commons Attribution License CC BY 4.0 , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Conditions, terms of use and publishing policy can be found at www.scienceopen.com .

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Figures: 5, Tables: 0, References: 7, Pages: 3

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Fabio Guarracino wrote:

In the manuscript “MitraClip procedure with two MitraClips after indirect annuloplasty with the MONARC device” dr. Rutschow and colleagues report on a case of severe MR in the context of LV cardiomyopathy treated with Mitraclip. The patient had undergone a Monarc device implantation four years before, but MR reduction had been incomplete and transient.

The case is interesting as the authors address the crucial topic of high risk patients requiring treatment of severe MR. However it shows some limitations that need to be addressed in order to improve the manuscript.

Major comments.

The authors should concisely explain the reason for residual MR and its worsening in a patient with a Monarc device.

Also they should answer to some questions.

The screening TEE exam seems quite poor. No data are reported on MV leaflets characteristics and length, and no data are available of annular dimensions. A Mitraclip device is only 16 mm long when its arms are open, therefore in dilated ventricles extreme dilation of MV annulus has to be taken into account as a limiting factor. How long was the AP MV diameter in this case? What about the tethering? Was it symmetric? How deep was the coaptation point?

Concerning the post grasping TEE, what about the residual MV area? How was this assessed?

Considering the effect of general anaesthesia on hemodynamics and on MR, which criteria did the authors use to assess residual MR under general anaesthesia and mechanical ventilation?

Is an immediate good reduction in MR a guarantee of competent MV on the long distance following Mitraclip?

Minor comment

The English language needs to be revised and several typos need to be amended. The supplemental material does not work.

2015-05-08 14:48 UTC

Rodrigo Estevez-Loureiro wrote:

I am happy to review this interesting paper regarding the use of MitraClip for challenging cases. MitraClip has gained wide clinical since it can be used for treating both functional and degenerative mitral regurgitation. Moreover, recent publications have addressed that this device may be useful as well in different and complex clinical scenarios such as acute MR after AMI, failed annuloplasty rings or MR associated to hypertrophic cardiomyopathy. This interesting paper highlights a new use for the MitraClip. Two clips were implanted in a patient with a prior indirect annuloplasty device and nearly complete reduction of MR was achieved. The case is appropriate and the images are interesting. However, the paper has as well some shortcomings. The English style is far from ideal and some sentences are poorly built. There is no description of how operators dealt with this difficult PML or if they used a special image technique for increasing the visibility of such leaflet.

2014-12-24 11:21 UTC

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Reviewed by Paolo Denti Reviewed by Rodrigo Estevez-Loureiro

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MitraClip procedure with two MitraClips after indirect annuloplasty with the MONARC device

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Abstract

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ScienceOpen Research

Most cited references 10

Percutaneous repair or surgery for mitral regurgitation.

Acute and 12-month results with catheter-based mitral valve leaflet repair: the EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study.

The double-orifice technique in mitral valve repair: a simple solution for complex problems.

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Comments

The case is interesting as the authors address the crucial topic of high risk patients requiring treatment of severe MR. However it shows some limitations that need to be addressed in order to improve the manuscript.

Major comments.

The authors should concisely explain the reason for residual MR and its worsening in a patient with a Monarc device.

Also they should answer to some questions.

Concerning the post grasping TEE, what about the residual MV area? How was this assessed?

Considering the effect of general anaesthesia on hemodynamics and on MR, which criteria did the authors use to assess residual MR under general anaesthesia and mechanical ventilation?

Is an immediate good reduction in MR a guarantee of competent MV on the long distance following Mitraclip?

Minor comment

The English language needs to be revised and several typos need to be amended. The supplemental material does not work.

Comment on this article

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Most referenced authors 131