Correction of Mitral Regurgitation in Nonresponders to Cardiac Resynchronization Therapy by MitraClip Improves Symptoms and Promotes Reverse Remodeling

Auricchio, Angelo; Schillinger, Wolfgang; Meyer, Sven; Maisano, Francesco; Hoffmann, Rainer; Ussia, Gian Paolo; Pedrazzini, Giovanni; Heyden, Jan Van der; Fratini, Simona; Klersy, Catherine; Komtebedde, Jan; Franzen, Olaf; Investigators, Permit-Care

doi:10.1016/j.jacc.2011.06.061

Cited by 240 publications

(168 citation statements)

References 27 publications

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“…45,46,60,[64][65][66][67][68] Percutaneous devices used to reshape the mitral annulus can be separated into indirect and direct types; the former are positioned in the coronary sinus, whereas the latter addresses the mitral annulus. Indirect annulopasty involves the placement of a device into the coronary sinus to promote favourable annulus remodelling, thereby optimizing leaflet coapta tion.…”

Section: Percutaneous Mitral Annuloplastymentioning

confidence: 99%

Therapeutic decision-making for patients with fluctuating mitral regurgitation

2015

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| Mitral regurgitation (MR) is a common, progressive, and difficult-to-manage disease. MR is dynamic in nature, with physiological fluctuations occurring in response to various stimuli such as exercise and ischaemia, which can precipitate the development of symptoms and subsequent cardiac events. In both chronic primary and secondary MR, the dynamic behaviour of MR can be reliably examined during stress echocardiography. Dynamic fluctuation of MR can also have prognostic value; patients with a marked increase in regurgitant volume or who exhibit increased systolic pulmonary artery pressure during exercise have lower symptom-free survival than those who do not experience significant changes in MR and systolic pulmonary artery pressure during exercise. Identifying patients who have dynamic MR, and understanding the mechanisms underlying the condition, can potentially influence revascularization strategies (such as the surgical restoration of coronary blood flow) and interventional treatment (including cardiac resynchronization therapy and new approaches targeted to the mitral valve).

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Section: Percutaneous Mitral Annuloplastymentioning

confidence: 99%

Therapeutic decision-making for patients with fluctuating mitral regurgitation

2015

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“…Before MitraClip treatment, 12 medications need to be optimized and, if applicable, cardiac resynchronization therapy should be performed. 13 The presence of a catheter laboratory and/or a hybrid operation room, and transesophageal echocardiography (TEE), are minimal requirements (►Table 3). Many authors recommend three-dimensional TEE, a specialized echocardiography laboratory, and an echocardiographic specialist with specialist expertise in the MitraClip System and/or expertise in MVR (►Tables 3 and 4).…”

Section: Recommendations For Structural Procedural and Documentatiomentioning

confidence: 99%

“…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%

“…Interventional cardiologist (expertise in transseptal puncture) 8,9,13,19,45,47,49,52 Special echocardiography training (Mitral valve repair, transseptal puncture) 3,8,9,19,45,49,52 Heart team-multidisciplinary (cardiac surgeon and cardiologist) 3,8,9,11,19,49,52 Abbreviations: TEE, transesophageal echocardiography; TTE, transthoracic echocardiography; 3D, three-dimensional. Before first implantation specific training of all participants and technical support of the manufacture 45,49,52 Performed by interdisciplinary heart team (cardiologist, interventionell cardiologist (with expertise in trans-septal puncture), cardiac surgeon, anesthesiologist with cardiac expertise) 11,19,45,49,53 Echocardiologist with special expertise and training in MVR and cardiac interventional procedures, special training for MitraClip intervention, special expertise in TEE and 3D TEE 8,9,11,19,25,32,34,45,49,52 Participation in registry or clinical trial 11,14,15,…”

Section: Personnel Resourcesmentioning

confidence: 99%

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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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“…At 31 days to 1 year, the pooled event rate for mortality was 13.0% [95% CI (9-18.3)], stroke was 1.6% [95% CI (0.8-3.2)], and repeat MVS was 1.3% [95% CI (0.7-2.6)] with the majority of patients in the mild/moderate MR grade and NYHA class after MC. The 30-day event rates for mortality and stroke were 16.8% (95% CI [14][15][16][17][18][19]) and 4.5% (95% CI [3.9-5.3]) after MVS, respectively. Conclusion: Based on high risk MC studies and high risk MVS data predominantly from STS database, patients with severe MR who are at HSR can be effectively treated with MC or MVS.…”

mentioning

confidence: 99%

MitraClip for severe symptomatic mitral regurgitation in patients at high surgical risk

Philip

Athappan

Tuzcu

et al. 2014

Cathet Cardio Intervent

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Background: The optimal treatment of patients with severe mitral regurgitation (MR) at high surgical risk (HSR) is unknown. Recently, the EVEREST II (Endovascular Valve Edgeto-Edge Repair) High Risk Study suggested MitraClip (MC) was a safe and effective treatment option. Methods: We performed a search strategy for MC or mitral valve surgery (MVS) in patients at HSR for surgical mortality (logistic EuroSCORE >18 or STS score > 10) using Medline databases, proceedings of international meetings, and the STS database. We identified 21 studies utilizing MC (n 5 3,198) and MVS (n 5 3,265, >90% from the STS database) from 2003 to 2013. Information about patient characteristics, surgical risk, and 30-day and 1-year outcomes were extracted. Results: Patients who underwent MC or MVS had a mean age of 74 6 10 years with no differences in surgical risk, NYHA class, or MR grade (P 5 0.46). Technical success was achieved in 96% of patients undergoing MC versus 98% in the MVS group (P 5 0.45). Patients undergoing MC were treated with one or two MC in 90% (n 5 2,878) with only a few requiring repeat MC (0.4%, n 5 13) or mitral surgery (0.3%, n 5 52) at 30 days. The pooled event rates for mortality was 3.2% (95% CI [2.5-4.2]), stroke was 1.1% (95% CI [0.7-0.2]) at 30 days. At 31 days to 1 year, the pooled event rate for mortality was 13.0% [95% CI (9-18.3)], stroke was 1.6% [95% CI (0.8-3.2)], and repeat MVS was 1.3% [95% CI (0.7-2.6)] with the majority of patients in the mild/moderate MR grade and NYHA class after MC. The 30-day event rates for mortality and stroke were 16.8% (95% CI [14][15][16][17][18][19]) and 4.5% (95% CI [3.9-5.3]) after MVS, respectively. Conclusion: Based on high risk MC studies and high risk MVS data predominantly from STS database, patients with severe MR who are at HSR can be effectively treated with MC or MVS. MC can be safely implanted in high risk patients with relatively low mortality and stroke risk. V C 2014 Wiley Periodicals, Inc.

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Correction of Mitral Regurgitation in Nonresponders to Cardiac Resynchronization Therapy by MitraClip Improves Symptoms and Promotes Reverse Remodeling

Abstract: FMR treatment with the MitraClip in CRT nonresponders was feasible, safe, and demonstrated improved functional class, increased LVEF, and reduced ventricular volumes in about 70% of these study patients.

Cited by 240 publications

References 27 publications

Therapeutic decision-making for patients with fluctuating mitral regurgitation

Therapeutic decision-making for patients with fluctuating mitral regurgitation

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

MitraClip for severe symptomatic mitral regurgitation in patients at high surgical risk

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