ABSTRACT: To describe a new approach to percutaneous mitral valve repair and an illustrative first-in-man experience, we introduce a suture mediated "double orifice", "edge-to-edge" procedure which can be an effective surgical therapy for mitral regurgitation (MR) in selected patient.
We describe a novel percutaneous approach to double orifice mitral repair utilising an intra-cardiac suture based system. The procedure was performed in 15 patients in four international centres. Endovascular suture based double orifice mitral repair was feasible with an acute reduction in the severity of MR by > or = 1 grade in nine of 15 patients. At 30 days improvement in MR appeared durable in six patients. Clinical utility was limited by technical difficulties, the inadequacies of current imaging modalities and suture dehiscence.
Percutaneous endovascular suture based cardiac repair is feasible. However, in utilising the current device clinical benefit was limited and the repair not durable. In the future, similar endovascular approaches may enable more complex cardiac repair.
EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 06/2009; 5(1):86-9. · 3.29 Impact Factor
ABSTRACT: The edge-to-edge (Alfieri) technique for mitral valve repair is a versatile method of treating mitral insufficiency. Because of its simplicity, it has been applied in minimally invasive surgery, and recently, in the design of endovascular closed-heart devices.
The purpose of this study was to evaluate the acute in-vivo safety and feasibility of a novel percutaneous mitral valve repair system based on Alfieri technique in an animal model.
Under general anesthesia, 11 pigs (90-100 kgs), underwent percutaneous Alfeiri procedure. The right femoral vein was punctured and the mitral valve was approached via a standard transeptal puncture. Combined intracardiac echo and fluoroscopic guidance was used. The procedure included: the positioning of a guide catheter for multiple access to the left atrium and for directing devices; the use of a therapy device to capture the free edge of the mitral valve leaflets using vacuum, and to deliver the suture to the valve and finally the fixation with a Nitinol suture clip, and trimming of the suture with a fastener catheter.
Leaflet capture, suture placement, and suture-clip deployment was successful in all 11 animals. There were no acute cardiac or access site complications. Procedural time (from wire in left atrium to completion of the procedure was 18 +/- 9 min (range 9-30 min). Blood loss was 67 +/- 44 ml (range 0-125 ml). A double orifice configuration was visible by echocardiography at the end of the procedure in all animals.
This acute animal study demonstrated the feasibility of a beating heart percutaneous Alfieri procedure in a non-diseased porcine valve using an endovascular suturing device to safely access the mitral valve, place a stitch through the mitral valve leaflets, and deploy a suture-clip that reproduces the surgical technique. Clinical application of this device in humans needs to be evaluated.
Catheterization and Cardiovascular Interventions 04/2007; 69(4):525-31. · 2.29 Impact Factor
ABSTRACT: High-quality live imaging assessment of cardiac valves and cardiac anatomy is crucial for the success of percutaneous catheter-based mitral valve (MV) repair techniques. We examined the use of intracardiac echocardiography (ICE) in providing online ICE images necessary for successful perctunaneous MV repair by Alfieri stitch technique-based percutaneous edge-to-edge device in a swine model.
ICE was performed in 20 healthy adult pigs (90 +/- 8 kg, mean +/- SEM). A 10F ICE catheter was advanced through the left femoral vein and the right jugular vein. Images were obtained from the right atrium, left atrium, right ventricle, and pulmonary artery. Fluoroscopy was used to locate the position of ICE catheter tip in different imaging windows.
An echocardiographic protocol was developed for focused visualization of target cardiac structures during the process of percutaneous MV repair. This included visualization of interatrial septum to guide transeptal puncture; to confirm transit of guidewire into the left atrium, across the MV into the left ventricle and across the aortic valve into the aorta; to assist in central positioning of guide catheter in the left atrium above and then across MV leaflets; and to visualize middle scallops of anterior and posterior MV leaflets in short- and long-axis views. Finally, location and orientation of the orifice of the therapy catheter against each MV leaflet was visualized to enable successful capture of MV leaflets, to confirm successful deployment of suture and double orifice (figure of 8" appearance of MV, and finally to confirm central deployment of clip at the site of suture.
An ICE protocol was developed to visualize serial cardiac structures to guide deployment of suture into the A2-P2 scallops of the MV and to confirm final result before release of clip.
Journal of the American Society of Echocardiography: official publication of the American Society of Echocardiography 03/2006; 19(2):147-53. · 2.98 Impact Factor