Cardioband, a transcatheter surgical-like direct mitral valve annuloplasty system: early results of the feasibility trial

Maisano, Francesco; Taramasso, Maurizio; Nickenig, Georg; Hammerstingl, Christoph; Vahanian, Alec; Messika–Zeitoun, David; Baldus, Stephan; Huntgeburth, Michael; Alfieri, Ottavio; Colombo, Antonio; Canna, Giovanni La; Agricola, Eustachio; Züber, Michel; Tanner, Felix C.; Topilsky, Yan; Kreidel, Felix; Kuck, Karl Heinz

doi:10.1093/eurheartj/ehv603

Cited by 159 publications

(97 citation statements)

References 25 publications

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“…This case report illustrates a successful implantation of Cardioband achieving a septolateral reduction of 30%, exactly the average of the 31 cases reported by Nickenig et al , with a consequent acute improvement in MR. The procedure was cumbersome, also because the longest band was required.…”

Section: Discussionsupporting

confidence: 80%

Unexpected delayed complete atrioventricular block after Cardioband implantation

Dini

Landi

Meucci

et al. 2018

Cathet Cardio Intervent

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The Cardioband system is a transcatheter direct annuloplasty device that is implanted in patients with severe symptomatic functional mitral regurgitation (MR) due to annulus dilatation and high surgical risk. This device covers the posterior two-thirds of the annulus, from the anterolateral to the posteromedial commissure, implanted in close proximity of the left circumflex artery, atrioventricular (AV) conduction system, and coronary sinus. We present the case of an 80-year-old-gentleman with prohibitive surgical risk, treated with Cardioband implantation for functional MR with an evident P1-P2 cleft and P2-P3 indentation, a relative contraindication to MitraClip implantation. We achieved procedural success with significative mitral annulus reduction (30% anteroposterior reduction from 37 to 26 mm) and MR reduction (from grade 4 to grade 1-2). A late onset Mobitz 2 AV block developed after 26 hr and evolved to complete AV block in the following day, requiring definitive biventricular pacemaker (PM). Less than 200 Cardioband implantations have been performed but, to our knowledge, this is the first reported AV block, possibly facilitated by the pre-existing bifascicular block, suggesting the opportunity of prolonged ECG monitoring after Cardioband like any other mechanical transcatheter structural intervention possibly affecting the AV conduction system.

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Section: Discussionsupporting

confidence: 80%

Unexpected delayed complete atrioventricular block after Cardioband implantation

Dini

Landi

Meucci

et al. 2018

Cathet Cardio Intervent

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“…It is easy to adjust the clamp position by just moving the external end of the delivery system and there is 1:1 transmission of device movement due to the proximity of access site to device therapy, as well as the use of a straight delivery system. The catheter manipulation time was just 18.5 ± 8.2 min, which was much less than that previously reported with MitraClip (157 ± 81 min) and other mature devices, such as Mitralign (96.2 ± 30.8 min), Cardioband (186 ± 46 min), and NeoChord (100–135 min) …”

Section: Discussionmentioning

confidence: 60%

A novel user‐friendly transcatheter edge‐to‐edge mitral valve repair device in a porcine model

Pan

Jilaihawi

et al. 2018

Cathet Cardio Intervent

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Objectives The present study was performed to evaluate the feasibility and safety of the ValveClamp system for transcatheter edge‐to‐edge mitral valve repair in a porcine model. Background The ValveClamp system is a novel, transapically delivered edge‐to‐edge mitral valve repair system designed for ease of operation. Methods Thirteen young adult swine were enrolled in the study. The procedure was performed via the transapical approach under epicardial echocardiography guidance. Results The acute procedure success rate was 92.3% (12/13). The catheter manipulation time was just 18.5 ± 8.2 min. Four pigs were explanted on the 14th day after the procedure. One pig died at the 20th day because of pneumonia. The other eight pigs lived to the study endpoint (140 days). No pig had severe mitral valve dysfunction. The gross observation showed that the clamp device was securely attached and created a double‐orifice mitral valve in all pigs except the failed one. In the eight pigs living to the endpoint, the clamp device was noted to be completely endothelialized. None of the 13 pigs developed infective endocarditis, thrombosis, thromboembolism, or valve impairment. In two pigs for which mitral regurgitation (MR) was created, the degree of MR was reduced from severe to trace after the device implantation. Conclusions It was feasible and safe to use ValveClamp to perform a catheter‐mediated edge‐to‐edge mitral valve repair in a porcine model. This system is potentially applicable as a novel user‐friendly system for the treatment of MR.

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“…The Cardioband technique (Edwards Lifesciences; Irvine, USA) is derived from the concept of surgical MV restrictive annuloplasty. The Cardioband is a direct transcatheter annuloplasty system, which is anchored into the annulus tissue at several points along the posterior MV annulus under 3D echocardiographic guidance . After complete implantation, the band is contracted by external rotation on the delivery catheter, thereby narrowing the septal–lateral dimension of the MV annulus until MR is sufficiently reduced on transoesophageal echocardiography.…”

Section: Transcatheter Mitral Valve Interventionsmentioning

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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Cardioband, a transcatheter surgical-like direct mitral valve annuloplasty system: early results of the feasibility trial

Abstract: This study demonstrates the feasibility and safety of percutaneous direct mitral annuloplasty with the Cardioband device in high-risk patients with MR.

Cited by 159 publications

References 25 publications

Unexpected delayed complete atrioventricular block after Cardioband implantation

Unexpected delayed complete atrioventricular block after Cardioband implantation

A novel user‐friendly transcatheter edge‐to‐edge mitral valve repair device in a porcine model

Mitral valve interventions in heart failure

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