Treatment of Chronic Functional Mitral Valve Regurgitation With a Percutaneous Annuloplasty System

Nickenig, Georg; Schueler, Robert; Dager, Antonio; Clark, Pedro Martinez; Abizaid, Alexandre; Siminiak, Tomasz; Buszman, Paweł; Demkow, Marcin; Ebner, Adrián; Asch, Federico M.; Hammerstingl, Christoph

doi:10.1016/j.jacc.2016.03.591

Cited by 112 publications

(42 citation statements)

References 23 publications

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“…This device is currently being tested in prospective multicenter trials (eg, MitraLign Percutaneous Annuloplasty System for Chronic Functional Mitral Valve Regurgitation [ALIGN]). The early results in 50 patients after 6 month in inverse LV‐remodeling and clinical improvement are excellent . A further promising device for percutaneous surgical—like direct mitral valve annuloplasty is the Cardioband System Valtech Cardio, Or Yehuda, Israel).40, Future studies will show if this systems may replace the Carillon System.…”

Section: Discussionmentioning

confidence: 99%

“…In the meantime, another procedure, the direct percutaneous mitral valve annuloplasty, has moved to the focus, the MitraLign System (MitraLign Inc., Tewksbury, MA, USA). It has already been released as the “most promising approach for transcatheter mitral and tricuspid valve annuloplasty, since it closely reproduces the conventional surgical approach.” With the MitraLign device, sutures and anchors can be placed through the posterior annulus of the mitral valve under the guidance of echocardiography and fluoroscopy. Once the anchored sutures are in place, the sutures are pulled together, and when the valve leaflets are close together, the sutures are locked with at least one stainless steel lock.…”

Section: Discussionmentioning

confidence: 99%

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Treatment of functional mitral regurgitation by percutaneous annuloplasty using the Carillon Mitral Contour System—Currently available data state

Bail

2017

J Interven Cardiology

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Results with regard to reduction of MR and inverse LV remodeling have been remarkable. Indication and selection criteria for suitable patients, the expected complications, and the long-term results with regard to survival and quality of life still remain unclear. The available results do not establish superiority of the Carillon Mitral Contour System and support the lack of a clear benefit. The approach with the Carillon Mitral Contour System should be limited to participants of prospective and randomized trials.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Treatment of functional mitral regurgitation by percutaneous annuloplasty using the Carillon Mitral Contour System—Currently available data state

Bail

2017

J Interven Cardiology

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“…Later reverse remodeling may contribute to further MR reduction. This compares favorably with 6% achieved using Mitralign transcatheter annular plication (Mitralign, Tewksbury, Massachusetts) (13), and Coapsys (Myocor, Inc., Maple Grove, Minnesota), 16% (14). These geometric changes are less pronounced than after surgical ring annuloplasty.…”

Section: Discussionmentioning

confidence: 67%

Mitral Loop Cerclage Annuloplasty for Secondary Mitral Regurgitation

Park

Chon

Lederman

et al. 2017

JACC: Cardiovascular Interventions

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OBJECTIVES This is an early feasibility clinical test of mitral loop cerclage annuloplasty to treat secondary mitral valve regurgitation. BACKGROUND Secondary mitral regurgitation is characterized by cardiomyopathy, mitral annular enlargement, and leaflet traction contributing to malcoaptation. Transcatheter mitral loop cerclage applies circumferential compression to the mitral annulus by creating a loop through the coronary sinus across the interventricular septum, protecting entrapped coronary arteries from compression, and interactive annular reduction under echocardiographic guidance. This is the first human test of mitral loop annuloplasty. METHODS Five subjects with severe symptomatic secondary mitral regurgitation underwent mitral loop cerclage, with echocardiographic and computed tomography follow-up over 6 months. RESULTS Mitral loop cerclage was successful in 4 of 5 subjects and aborted in 1 of the 5 because of unsuitable septal coronary vein anatomy. Immediately and over 6 months, measures of both mitral valve regurgitation (effective orifice area and regurgitation fraction) and chamber dimensions (left atrial and left ventricular volumes) were reduced progressively and ejection fractions increased. Two with persistent and permanent atrial fibrillation spontaneously reverted to sinus rhythm during follow-up. One subject experienced a small myocardial infarction from an unrecognized small branch coronary occlusion. Another, experiencing cardiogenic shock at baseline, died of intractable heart failure after 6 weeks. CONCLUSIONS In this first human test, mitral loop cerclage annuloplasty was successful in 4 of 5 attempts, caused reverse remodeling (reduction in secondary mitral regurgitation and heart chamber volumes), and suggested electrical remodeling (reversion of atrial fibrillation). Further evaluation is warranted.

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“…By cinching the sutures, the mitral annulus becomes reduced. 18 In the Mitralign Percutaneous Annuloplasty First-in-Man Study, 36 the device was successfully implanted in 50 out of 71 patients with secondary MR. The 30 day mortality was 4.4%.…”

Section: Mitralignmentioning

confidence: 99%

Mitral valve interventions in heart failure

et al. 2018

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Secondary mitral regurgitation (MR) results from left ventricular dilatation and dysfunction. Quantification of secondary MR is challenging because of the underlying myocardial disease. Clinical and echocardiographic evaluation requires a multi‐parametric approach. Severe secondary MR occurs in up to one‐fourth of patients with heart failure with reduced ejection fraction, which is associated with a mortality rate of 40% to 50% in 3 years. Percutaneous edge‐to‐edge mitral valve repair (MitraClip) has emerged as an alternative to surgical valve repair to improve symptoms, functional capacity, heart failure hospitalizations, and cardiac haemodynamics. Further new transcatheter strategies addressing MR are evolving. The Carillion, Cardioband, and Mitralign devices were designed to reduce the annulus dilatation, which is a frequent and important determinant of secondary MR. Several transcatheter mitral valve replacement systems (Tendyne, CardiAQ‐Edwards, Neovasc, Tiara, Intrepid, Caisson, HighLife, MValve System, and NCSI NaviGate Mitral) are emerging because valve replacement might be more durable compared with valve repair. In small studies, these interventional therapies demonstrated feasibility and efficiency to reduce MR and to improve heart failure symptoms. However, neither transcatheter nor surgical mitral valve repair or replacement has been proven to impact on the prognosis of heart failure patients with severe MR, which remains high with a mortality rate of 14–20% at 1 year. To date, the primary indication for treatment of secondary severe MR is the amelioration of symptoms, reinforcing the value of a Heart Team discussion. Randomized studies to investigate the treatment effect and long‐term outcome for any transcatheter or surgical mitral valve intervention compared with optimized medical treatment are urgently needed and underway.

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Treatment of Chronic Functional Mitral Valve Regurgitation With a Percutaneous Annuloplasty System

Abstract: Percutaneous direct annuloplasty is feasible and safe in high-risk FMR patients. This treatment initiates LV reverse remodeling, and provides clinical improvement during 6 months after treatment. (Mitralign Percutaneous Annuloplasty First in Man Study; NCT01852149).

Cited by 112 publications

References 23 publications

Treatment of functional mitral regurgitation by percutaneous annuloplasty using the Carillon Mitral Contour System—Currently available data state

Treatment of functional mitral regurgitation by percutaneous annuloplasty using the Carillon Mitral Contour System—Currently available data state

Mitral Loop Cerclage Annuloplasty for Secondary Mitral Regurgitation

Mitral valve interventions in heart failure

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