A heart team’s perspective on interventional mitral valve repair: Percutaneous clip implantation as an important adjunct to a surgical mitral valve program for treatment of high-risk patients

Treede, Hendrik; Schirmer, Johannes; Rudolph, Volker; Franzen, Olaf; Knap, Malgorzata; Schlüter, Michael; Conradi, Lenard; Seiffert, Moritz; Koschyk, Dietmar; Meinertz, Thomas; Baldus, Stephan; Reichenspurner, Hermann

doi:10.1016/j.jtcvs.2011.09.033

Cited by 41 publications

(36 citation statements)

References 16 publications

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“…As in previous studies, clip embolization was not observed in the present registry. In fact, only a single case of clip embolization has been reported worldwide, so far [1,[3][4][5]8,[16][17][18][19][20][21][22][23][24][25][26][27][28][29] (Table V). Partial clip detachment from one leaflet was rarely observed (2% in the present analysis) and occurred spontaneously or during advancement of a second clip for residual MR.…”

Section: Discussionmentioning

confidence: 99%

Risk and outcomes of complications during and after MitraClip implantation: Experience in 828 patients from the German TRAnscatheter mitral valve interventions (TRAMI) registry

Eggebrecht

Schelle

Puls³

et al. 2015

Cathet Cardio Intervent

112

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Aims: To analyze risk and outcomes of complications during and after MitraClip implantation using multicenter data from the prospective German Transcatheter Mitral Valve Interventions (TRAMI) registry. Methods and Results: Data of 828 patients (mean age: 76.0 [71-81] years, 327 (40%) females) undergoing MitraClip implantation in Germany between 2010 and 2013 were analyzed. Most patients (85%) underwent elective procedures with on average implantation of 1.4 6 0.6 clips. Emergent cardiac surgery was not required; a single patient died intraoperatively. During the in-hospital period, complications occurred in 215 (25.9%) patients, of which 106 (12.8%) were considered major. Major bleeding complications were among the most frequent major complications (7.4%), while rates of pericardial tamponade (1.9%) and clip-specific complications (embolization: 0%, partial clip detachment: 1.9%) were low. In-hospital death, stroke or myocardial infarction (MACCE) occurred in 2.2, 0.9, and 0% patients, respectively. Patients with complications appeared to be older and more critically ill preinterventionally; in-hospital mortality was significantly higher as compared to those without procedural complications. Conclusions: MitraClip implantation appears to be a safe treatment option with low rates of MACCE and clip-specific complications. Catheterization and Cardiovascular Interventions 86: 728-735 (2015) Nevertheless, MitraClip therapy is not without complications. Careful patient selection and improvements in preventing peri-procedural bleeding have the potential of reducing post-procedural complications and improving outcomes. V C 2015 Wiley Periodicals, Inc.

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Section: Discussionmentioning

confidence: 99%

Risk and outcomes of complications during and after MitraClip implantation: Experience in 828 patients from the German TRAnscatheter mitral valve interventions (TRAMI) registry

Eggebrecht

Schelle

Puls³

et al. 2015

Cathet Cardio Intervent

112

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“…[16][17][18][19][20][21][22][23][24][25][26][27] A recent pooled analysis of 351 patients in the EVEREST II High Risk Registry and the REALISM (Real World Expanded Multi-center Study of the MitraClip System) Continued Access Study demonstrated an implantation success of 96%. 19 These patients were all considered high risk for surgery (estimated Society of Thoracic Surgeons score >12%).…”

Section: Evidence From Registriesmentioning

confidence: 99%

Current Status and Clinical Development of Transcatheter Approaches for Severe Mitral Regurgitation

Grasso

Capodanno

Tamburino

et al. 2015

Circ J

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Transcatheter mitral valve intervention has emerged as an effective treatment option for symptomatic severe mitral regurgitation in patients considered to be inoperable or at high operative risk for surgical mitral valve surgery. Most transcatheter approaches are modifications of existing surgical approaches. Transcatheter edge-to-edge mitral valve repair with the MitraClip system has the largest clinical experience to date, as it offers a sustained clinical benefit in selected patients. This review aims to provide an up-to-date overview of transcatheter mitral valve interventions, including leaflet repair, annuloplasty, and mitral valve implantation. (Circ J 2015; 79: 1164 -1171

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“…In the early postoperative course, the MAE Multimorbidity, high-risk patient, contraindication for oMVS: log EuroScore > 20% and/or STS-Score >10% 11,13,14,19,21,24,26,31,35,42,43,48,49 AHA/ASC/ESC criteria for oMVS fulfilled [10][11][12]20,21,38,40,43,45,47,50 Previous cardiac surgery 13,14,20,26,40,45 Echocardiographic criteria for treatment with MitraClip system fulfilled 8,9,19,32,33 Chest radiation/porcelain aorta 8,9,16,26,45,51 Possible indications…”

Section: Recommendations For Structural Procedural and Documentatiomentioning

confidence: 99%

The MitraClip System: A Systematic Review of Indications, Procedural Requirements, and Guidelines

Bail

Doebler

2013

Thorac cardiovasc Surg

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Background Transcatheter interventions (TIs) are new treatment options for patients with severe mitral valve regurgitation (MR) who cannot undergo open mitral valve surgery (oMVS). Despite the lack of scientific evidence demonstrating the benefit of these procedures, there has been a steady increase in their use. The aim of this study was to evaluate whether there are any indication criteria, process, and structural requirements, or scientific society and institutional guidelines for the use of the MitraClip System (Abbott Vascular-Structural Heart, Menlo Park, California, United States). Method A systematic literature search was conducted using the common medical and scientific databases. Of a total of 1,395 publications, 42 publications met the inclusion criteria and were included for the evaluation. Results Despite a general lack of high-quality evidence and of consensus recommendations from scientific societies or institutions, an assessment of indication criteria and process and structural requirements for the use of the MitraClip System, including noncontrolled studies, was possible. The majority of studies agree that an interdisciplinary heart team including a cardiothoracic surgeon, an interventional cardiologist, and an echocardiographic specialist should actively participate in clinical decision making, and in the procedure itself. Participation in a scientific-based registry is strongly recommended. Conclusions The MitraClip System is a promising procedure, but evidence-based indication criteria, structural, and process requirements for its use are lacking. Further results from prospective, randomized controlled trials are needed to determine patients, potential adverse events, device durability, and long-term follow-up. MitraClip should be used in only a small number of centers with procedure-specific, high-quality surgical and interventional experience, and training.

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A heart team’s perspective on interventional mitral valve repair: Percutaneous clip implantation as an important adjunct to a surgical mitral valve program for treatment of high-risk patients

Abstract: Clip-based percutaneous mitral valve repair is a safe, low-risk, and effective therapeutic option in symptomatic patients with a high risk for surgery and does not exclude later surgical repair.

Cited by 41 publications

References 16 publications

Risk and outcomes of complications during and after MitraClip implantation: Experience in 828 patients from the German TRAnscatheter mitral valve interventions (TRAMI) registry

Risk and outcomes of complications during and after MitraClip implantation: Experience in 828 patients from the German TRAnscatheter mitral valve interventions (TRAMI) registry

Current Status and Clinical Development of Transcatheter Approaches for Severe Mitral Regurgitation

The MitraClip System: A Systematic Review of Indications, Procedural Requirements, and Guidelines

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