Interventional Cardiology
Percutaneous Heart Valve Therapy – Options, Risks and Benefits
Gian Paolo Ussia,1,2 Marco Barbanti,1 Massimiliano Mulè1 Valeria Cammalleri,1 Marilena Scarabelli,1 and Corrado Tamburino1,2
1. Division of Cardiology, Ferrarotto Hospital, University of Catania; 2. Excellence Through Newest Advances (ETNA) Foundation
Abstract
Transcatheter valve therapy is emerging as an effective option for aortic valve stenosis and mitral regurgitation. In 1992, Anderson demonstrated the feasibility of percutaneous implantation of catheter-based valve prosthesis. Since then, many technical and device advances have been made, and transcatheter aortic valve implantation and mitral valve repair have became a concrete alternative to surgical replacement.
Keywords
Aortic stenosis, mitral regurgitation, replacement, repair, transcatheter
Disclosure: Gian Paolo Ussia is proctor physician for CoreValve® . The remaining authors have no conflicts of interest to declare.
tambucor@unict.it
Valvular heart disease is one of the most discussed health topics, as it is often associated with significant morbidity and mortality. To date, aortic stenosis (AS) and mitral regurgitation (MR), respectively, are the first and second most common heart valve diseases in western countries. It has been extensively demonstrated that surgical treatment with valve repair or replacement with mechanical or bioprosthetic valve implantation can modify the natural history of the disease course, yielding excellent short- and long-term results, justifying their role as ‘gold-standard’ therapies for these pathologies.1,2
However, these
procedures are also associated with significantly higher rates of immediate and long-term complications in an expanding subgroup of patients (in particular the elderly and patients with several co-morbidities); this phenomenon has led to an increasing incidence of patients affected by critical MR and AS who are denied or refused surgery.3,4
The advent of transcatheter interventional techniques such
as percutaneous valve implantation or repair offers a unique opportunity to treat patients in this subgroup who were, until now, considered to be poor candidates for conventional surgical treatment. In this respect, the development of percutaneous valve techniques is evocative of the evolution of percutaneous treatment of coronary artery disease. Catheter-based treatment of valvular heart disease was investigated in 1992 when Andersen demonstrated the feasibility of percutaneous ‘closed-chest’ implantation of transcatheter aortic valve bioprosthesis in animal models.5
In 2000, Philippe Bonhoeffer6 reported
the first transcatheter implantation of a stent-mounted bovine jugular vein valve in the pulmonary position. Two years passed before the first human implantation of a percutaneous aortic valve, which was performed by Alain Cribier in a inoperable patient affected by severe symptomatic AS.7
frontier that interventional cardiology has been exploring.8
Finally, percutaneous treatment of MR is the latest A lot of
technical and device advances have been made and transcatheter aortic and mitral valve therapy, after some controversy, is becoming more than an ‘ideal’.
© T O UCH BRIEFINGS 2010
Percutaneous Aortic Valve Therapy
AS has been the focus of percutaneous treatments since the mid- 1980s. Aortic valvuloplasty for AS had historically been performed with direct vision.9
Catheter-based percutaneous valvuloplasty had
been attempted with good short- and long-term results in paediatric populations, and has remained the procedure of choice in congenital AS.10
Thus, percutaneous balloon aortic valvuloplasty was proposed as an alternative to cardiac surgery for AS treatment,11,12
but rapidly fell
into disuse secondary to high restenosis rates and lower survival at follow-up compared with surgical aortic valve replacement (SAVR).13 Thus, transcatheter aortic valve implantation (TAVI) represents the last frontier of valve disease therapy. Today, several devices are under experimentation, but only two TAVI systems are currently in the advanced stages of clinical evaluation and have achieved the CE mark in the European Community: the balloon-expandable Edwards- SAPIEN™ (ES) aortic valve (Edwards Lifescience, Irvine, California)7 and the third 18 French (Fr) generation of self-expandable CoreValve Revalving System® (CRS) prostheses (Medtronic Inc., Minnesota), which represent the latest model of a prosthesis implanted for the first time in a human by Grube in 2005.14
CE Mark Devices
Edwards-SAPIEN
The Edwards-SAPIEN percutaneous heart valve (see Figure 1A) consists of tri-leaflet bovine pericardial valve implanted in a stainless- steel stent. Two diameters of the valve are available (23x14.5 and 26x16mm), which use a delivery catheter of 22 and 24Fr, respectively. The 23mm prosthesis is suitable for annuli from 18 to 22mm and the 26mm prosthesis from 21 to 25mm. The device is composed of four components: the percutaneous aortic valve prosthesis; a flexible delivery catheter system (Retroflex 2 catheter, Edwards Lifescience); a 24Fr introductory system; and a loading system (‘crimper’). The valve is mechanically crimped onto a balloon catheter before implantation
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