Modeling the Interaction Between the Coronary Sinus and the Proximal Anchor Stent in Percutaneous Transvenous Mitral Annuloplasty

Author(s):  
Wei Sun ◽  
Milton DeHerrera

Surgical treatment of severe functional mitral regurgitation (MR) often involves mitral annuloplasty, a procedure where a flexible or rigid annuloplasty ring is used to downsize the dilated mitral valve annulus (MA) and improve leaflet apposition by posterior annular correction. Recently various minimally invasive percutaneous transvenous mitral annuloplasty (PTMA) devices have been tested in patients who are not suitable candidates for a surgical procedure involving a thoracotomy. The approach is based on the concept that by utilizing the parallel location of the coronary sinus (CS) to the mitral annulus, a device, that can reshape the annulus, can be percutaneously deployed within the coronary sinus (CS) and the great cardiac vein (GCV). When the implanted device deforms, it shortens the MA anterior-posterior dimension and decreases mitral regurgitation (MR) (Fig. 1). Although the approach has been shown to be promising, PTMA device dysfunction and fatigue fracture have been reported in several firstin-human clinical trials (1). We hypothesize that quantitative understanding of the biomechanical interaction between the venous tissue, the mitral improve the efficacy of the PTMA treatment of MR. In this study, we aim to model interactions between the PTMA proximal anchor and the CS using computational tools.

2009 ◽  
Vol 5 (1) ◽  
pp. 67
Author(s):  
Lutz Buellesfeld ◽  
Lazar Mandinov ◽  
Eberhard Grube ◽  
◽  
◽  
...  

Functional mitral regurgitation affects a substantial proportion of patients with congestive heart failure due to myocardial infarction or dilated cardiomyopathy. Functional mitral regurgitation greatly increases morbidity and mortality. Surgical annuloplasty is the standard of care for symptomatic patients with moderate or severe functional mitral regurgitation; however, a large number of patients are refused surgery. Several percutaneous approaches have been developed to address the need for less invasive treatment of mitral annulus dilatation. Devices using coronary sinus to cinch the mitral annulus are relatively easy to use; however, a number of factors may limit their clinical application, such as suboptimal anatomical relationship between the coronary sinus and mitral annulus, risk of coronary artery compression, large variability in the coronary venous anatomy and conflict with other therapies such as ablation or cardiac resynchronisation. Direct mitral annuloplasty is anticipated to be more effective than the coronary sinus approaches; however, it has yet to prove its safety and efficacy in carefully designed clinical trials. The best candidates and the best timing for each percutaneous mitral annuloplasty therapy, whether direct or indirect, have yet to be identified.


Author(s):  
Thuy M. Pham ◽  
Qian Wang ◽  
Milton DeHerrera ◽  
Wei Sun

Functional mitral regurgitation (MR) is the consequence of left ventricular dysfunction occurring after ischemic heart disease and often has poor prognosis. Surgical repair and replacement of the mitral valve are currently being used to treat severe functional MR However, the technique carries high mortality rate [1] and is not suitable for patients with comorbidities and advanced age [2]. Recently, a new non-surgical intervention, percutaneous transvenous mitral annuloplasty (PTMA), is emerging as an attractive endovascular alternative that is less invasive, less recovery time, and cost effective. The device is delivered percutaneously into the coronary sinus (CS) vessel and once embedded, it contracts and shortens the septo-lateral distance of the mitral annulus, hence improve MR. However, despite of its feasibility, current clinical trials reported severe adverse events, such as device fracture [3]. The biomechanical interaction between the CS wall and the stent plays a critical role in the outcome of the deployment and the device performance. In this study, we proposed to analyze this interaction by developing Finite Element (FE) models of the CS vessel and the PTMA anchors and analyzing the peak stresses, strains, interaction forces (shear, normal) after the deployment of the proximal and distal anchors into a realistic patient-specific CS model.


Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Stefan Sack ◽  
Philipp Kahlert ◽  
Luc Bilodeau ◽  
Luc Pierard ◽  
Patrizio Lancellotti ◽  
...  

Recently, several approaches have been developed for percutaneous mitral valve repair. The percutaneous transvenous mitral annuloplasty system (PTMA TM , Viacor Inc., Wilmington, USA) is an indirect annuloplasty device deployed within the coronary sinus (CS). Its mechanism is based on reduction of the anterior-posterior diameter of the mitral annulus to decrease mitral regurgitation (MR) by reestablishing leaflet coaptation in functional MR. We report the ongoing first-in-human experience with this non-stented device. 27 heart failure patients (NYHA II–IV) with functional MR II–III were enrolled at 5 centers. Via subclavian access, a multi-lumen diagnostic catheter was positioned within the anterior interventricular vein of the CS. Nitinol rods of various length and stiffness patterns were subsequently introduced into the lumina in order to exert pressure to the posterior mitral leaflet and to reduce AP diameter. Under fluoroscopic and echo guidance, different rod combinations were evaluated for maximal effectiveness before exchanging the diagnostic system to the permanent device. After assuring significant MR reduction by the permanent implant, the whole device was implanted in a subcutaneous pocket. 8 patients were excluded prior procedure due to unfavorable CS anatomy. The remaining 19 patients proceeded through a complete diagnostic exam. While the device was ineffective in 6 cases, echocardiography revealed a significant reduction of MR in 13 patients. 9 of these patients underwent successful implantation of the permanent device. 4 devices were subsequently removed, one at 7 days due to device fracture and the other 3 when the patients were referred for annuloplasty surgery due to device migration or diminished efficacy. Sustained reduction in MR and AP dimensions was noted in the remaining 4 long-term implants. No procedure related adverse events with permanent sequelae were observed in all patients. Initial human experiences with the PTMA TM device demonstrate safety and feasibility of this method as well as sustained favorable geometric modifications of the mitral annulus with reduction of MR in responding patients.


2013 ◽  
Vol 16 (5) ◽  
pp. E295-E297 ◽  
Author(s):  
Joseph Lamelas ◽  
Christos Mihos ◽  
Orlando Santana

In patients with functional mitral regurgitation, the placement of a sling encircling both papillary muscles in conjunction with mitral annuloplasty appears to be a rational approach for surgical correction, because it addresses both the mitral valve and the deformities of the subvalvular mitral apparatus. Reports in the literature that describe the utilization of this technique are few, and mainly involve a median sternotomy approach. The purpose of this communication is to describe the technical details of performing this procedure via a minimally invasive approach.


2021 ◽  
Vol 16 (13) ◽  
pp. 1106-1113
Author(s):  
Stephen Worthley ◽  
Simon Redwood ◽  
David Hildick-Smith ◽  
Tony Rafter ◽  
Alan Whelan ◽  
...  

Author(s):  
Michal Jaworek ◽  
Andrea Mangini ◽  
Edoardo Maroncelli ◽  
Federico Lucherini ◽  
Rubina Rosa ◽  
...  

Abstract Transcatheter therapies are emerging for functional mitral regurgitation (FMR) treatment, however there is lack of pathological models for their preclinical assessment. We investigated the applicability of deer hearts for this purpose. 8 whole deer hearts were housed in a pulsatile flow bench. At baseline, all mitral valves featured normal coaptation. The pathological state was induced by 60-minutes intraventricular constant pressurization. It caused mitral annulus dilation (antero-posterior diameter increase from 31.8 ± 5.6 mm to 39.5 ± 4.9 mm, p = 0.001), leaflets tethering (maximal tenting height increase from 7.3 ± 2.5 mm to 12.7 ± 3.4 mm, p < 0.001) and left ventricular diameter increase (from 67.8 ± 7.5 mm to 79.4 ± 6.5 mm, p = 0.004). These geometrical reconfigurations led to restricted mitral valve leaflets motion and leaflet coaptation loss. Preliminary feasibility assessment of two FMR treatments was performed in the developed model. Deer hearts showed ability to dilate under constant pressurization and have potential to be used for realistic preclinical research of novel FMR therapies.


Circulation ◽  
2009 ◽  
Vol 120 (4) ◽  
pp. 326-333 ◽  
Author(s):  
Joachim Schofer ◽  
Tomasz Siminiak ◽  
Michael Haude ◽  
Jean P. Herrman ◽  
Jindra Vainer ◽  
...  

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