Cardiovascular Pathology 12 (2003) 322 344

Mechanical heart valve prostheses: identification and evaluation (erratum)

Jagdish Butanya,*, Manmeet S. Ahluwaliaa, Craig Munroea, Cristina Fayeta, Christina Ahna, Patrick Blita, Charis Keprona, Roberto J. Cusimanob,c, Richard L. Leaska
a

Department of Pathology E4-322, Toronto General Hospital, Toronto, ON, Canada M5G 2C4 b Cardiovascular Surgery, Toronto General Hospital, Toronto, ON, Canada M5G 2C4 c University of Toronto, Toronto, ON, Canada M5G 2C4 Received 31 July 2002; received in revised form 20 August 2002; accepted 20 August 2002

Abstract Mechanical heart value prostheses have been in use since the 1950s. Many prostheses have been used for a while and then discontinued. Today, there are a large number and variety of prostheses in use and an even larger variety that are in place in patients. These may be explanted at any time for a number of reasons. It is essential for the practicing pathologist to be able to identify the prosthesis and be aware of some of its reported complications and modes of failure. This article, and a second one on bioprosthetic heart valves, is designed as a ready reference guide to heart valve prostheses, their important identifying features, their common complications, and modes of failure. It should help in the accurate identification of explanted prosthetic valves and more definitive reports. This accuracy of identification as well as tracking of abnormalities noted will, we hope, permit the identification of new failure modes and the recording of causes of failure of new (or even modified) prosthetic heart valves. D 2003 Elsevier Inc. All rights reserved.
Keywords: Heart valves; Prosthetic mechanical heart valve

1. Introduction Prosthetic heart valves have been in use for over 40 years. The first heart valve substitute was actually placed in the descending thoracic aorta by Hufnagel (Hufnagel valve) in 1952 [1]. With the availability of cardiopulmonary bypass, the first orthotropic heart valve replacements were performed in 1960 [2,3]. Today, patients with significant valvular lesions, stenotic or regurgitant, are routinely managed by the replacement (or repair) of the diseased valve. Heart valve prostheses are generically classified as mechanical heart valves (MHVs), which have only synthetic or nonbiological components and bioprosthesis (or tissue valves), which are made, at least in part, of biological components [4]. Worldwide, the number of prosthetic heart valves implanted is around 250,000 and is increasing at the rate of 5 7% per year [5]. Of all valves implanted, 60,000

* Corresponding author. Tel.: +1-416-340-3003; fax: +1-416-340-4213. E-mail address: jagdish.butany@uhn.on.ca (J. Butany). 1054-8807/02/$ see front matter D 2003 Elsevier Inc. All rights reserved. doi:10.1016/S1054-8807(02)00105-4

75,000 are implanted in the United States of America. Worldwide, approximately 55% of implanted prosthetic heart valves are mechanical and 45% biological. In developed countries, percentages are reversed with biological valves holding 55% of the market. The use of MHVs is increasing at the rate of 3 5% per year, while bioprosthesis implants are increasing at 8 11% per year [5]. All MHV prostheses have a similar basic structure with three essential components: (1) the occluder, (2) the housing and (3) the sewing ring. The occluder is usually one or more rigid moveable parts which may be a ball (as in the StarrEdwards valves), a disc (free floating as in the Bjork-Shiley valves) or a hinged leaflet, which may be circular or semicircular. The housing may include a cage-like structure that helps the occluder to move by guiding and restricting its movement and a valve base or body, which is a ring made of metal (alloy) or a graphite coated with pyrolytic carbon, and supports the cage/struts and provides the seat for the occluder. The occluder fits in the housing, which has the fabric-sewing cuff attached to it, to allow implantation of the device. Most contemporary MHV prostheses have

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pyrolytic carbon as a major component, while some have metal components also. The sewing cuff is made with synthetic fabrics, with or without a filler between the layers of the fabric. Other refinements of this basic structure may be seen. MHV prostheses can be divided into two kinds based on their flow pattern, those with lateral flow such as the ball in cage valves and those with more central flow such as the tilting disc and bileaflet valves. Prosthetic heart valves of every kind work on the simple principle of passive movement, wherein closure depends on the pressure gradients and changes of blood flow in the heart. The competency of valve substitutes is generally related to the structure of the prosthesis and, more specifically, the way the prosthesis occluder is seated. Most MHV prostheses have a minimal degree of incompetence built in (1 5%) to allow backwash of the components to inhibit thrombosis. The features of an ideal heart valve were enunciated by Harken et al. [3] in 1962 and have since been modified [6]. To this day, these criteria are not fulfilled by any one prosthetic heart valve. Prostheses are frequently associated with complications that impact significantly on the patients prognosis after heart valve replacement surgery [7]. Prosthetic heart valves are increasingly seen and will continue to be seen by surgical pathologists when they are removed at reoperation or when a patient who has had one or more valves replaced comes to autopsy. There are many excellent reviews available on the pathology of heart valve prostheses and many more will be available in the future about the current generation of prostheses [8,9]. This paper and another on bioprostheses, which will follow in a subsequent issue of this journal, are meant to provide the pathologist with a ready reference to contemporary prosthetic heart valves, in an effort to help identify them and to familiarize themselves with major known complications associated with particular devices. A few of these valves have been used for many years and a good body of literature is available about them. Many others have been in use for relatively short periods and definitive information about them is not yet available. The detailed examination of these prostheses by skilled pathologists will have an immense impact on the accumulation of a body of information about these devices. This will help in deciding the value of individual types of devices and to compare different devices with each other. Heart valve prostheses have many common complications. These include prosthesis-related complications such as device failure, whether design- or materials-related. Complications may also be related to the host, including infections and tissue overgrowth. The lifelong use of anticoagulants is mandatory for all patients with MHV prostheses. This treatment is associated with its own set of complications, such as hemorrhage. Many of these complications necessitate urgent removal of the device and its replacement. A working knowledge about each device is clearly essential when examining these explanted devices.

Numerous heart valve substitutes have been designed over the last 50 years. Many of these are no longer in use. In this paper, we have described heart valve prostheses that are currently being implanted in North America and, as well, the rest of the world. We have also described some that, though discontinued, continue to be explanted, and hence will be seen by pathologists for many years to come. We have excluded many that have been discontinued long ago, whose implant numbers were small and are highly unlikely to be seen today. Explanted prostheses if not easily identified should be referred to a pathologist with an interest in prosthetic heart valves, for detailed analyses. We have divided MHVs by occluder types and then described them (where necessary) alphabetically (by manufacturers names). The authors do not have any bias whatsoever for or against any manufacturer or for that matter any particular prosthetic heart valve.

2. Ball in cage 2.1. The Starr-Edwards prosthesis Model: Starr-Edwards 1260 (other Starr-Edwards mechanical prostheses include model 1000, 1200, 2300, 2310, 2320, 2400, 6000, 6120, 6300, 6310, 6320 and 6400). Type: Caged ball. Technical information: Manufactured and sold by Edwards Lifesciences (formerly Baxter Healthcare). The Starr-Edwards ball in cage model was the first commercially available mechanical prosthetic heart valve; introduced clinically in September of 1960 [10]. The aortic model 1260 was first implanted in 1968 and is still in use in some countries (Fig. 1A). A four-strut (mitral model 6400) with a hollow metal ball and the struts covered by cloth was used for some time (Fig. 1B). The mitral model 6120 is also in current use. This model has a four-strut cage (Fig. 1C,D) as opposed to the three-strut cage of model 1260. All other Starr-Edwards caged ball models have been discontinued [11]. Size range and available dimensions: Model 1260: 21 31 mm. Orifice diameters: 13 19 mm [11]. Physical characteristics: The caged ball construction gives the valve its characteristic lateral flow mechanism due to the centrally seated occluding poppet. Poppet material: Silicone rubber (silastic) with 2% barium sulfate by weight for radiologic identification [11]. Housing and cage material: Stellite (R) alloy no. 21; three monocast struts (model 6120 four struts), which join at the apical region [11]. Sewing ring material: Knitted, porous Teflon (TM) and polypropylene cloth [11]. Radiographic characteristics: Radiopaque closed cage profile with four struts, no projecting feet, tapered strut junction 11 (Fig. 1C,D). Other Starr-Edwards caged ball models differ slightly in design.

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Fig. 1.

Potential complications: Early models of the StarrEdwards prostheses were reported to show poppet damage (cracks) and occasionally embolization [10]. Thrombus formation and pannus growth may occur at the base of the struts and the apex of the closed cage, the latter potentially leading to orifice stenosis and improper poppet seating with resulting valvular incompetence [12]. Hemodynamic injury to the aortic intima with subsequent thrombosis and fibrous plaque formation to the endothelial lining can also occur, especially at the proximal end of the ascending aorta [12]. Paravalvular leaks do occur, as does infective endocarditis [13,14]. In valves made prior to 1966, the silastic poppet often imbibed lipid and the dimension of the poppet increased in comparison to the original specifications, leading to a change in color and occasionally to ball variance. This leads to decreased valve excursion, increased valvular regurgitation [15] and, in some cases, even sudden death [16]. Related to the high profile of this prosthesis, the valve struts can get trapped in scar tissue on the left

ventricular free wall or on the inter ventricular septum. (Most of these problems have largely been eliminated, but may still occasionally be seen.) Additional comments: Although chronologically a very old valve, the Starr-Edwards caged ball prostheses was for many years the gold standard against which other valves were compared. These valves have a longer history of clinical usage than any other heart valve prosthesis [17]. Pathologists may still observe these valves upon explantation. FDA approval: Only models 1260 and 6120 are currently approved in North America.

3. Single leaflet/tilting disc 3.1. The AorTech Ultracor mechanical valve Model: AorTech Ultracor U19A U29A (aortic) and U23M U33M (mitral).

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Fig. 2.

freedom from thrombosis at 5 years of 99% for the mitral position and 100% for both the aortic and double valve replacements (DVRs) [18]. Another study consisting of 94 patients observed no thrombosed valves during a 5-year follow-up period [19]. Li et al. [18] reported a freedom from hemorrhage at 5 years of 91% (AVR) and 94% (MVR), while Sin et al. [19] reported a 5-year freedom of 89%. In addition, there exists an elevated risk of endocarditis with prosthetic heart valve replacement. Actuarial 5-year freedom from endocarditis has been reported at 96% [19] and, from another source, 99% (AVR) and 97% (MVR) [18] for the Ultracor valve. However, the current literature on the Ultracor valve is limited and further reports are needed to confirm these findings. FDA approval: The Ultracor valve has obtained the CE mark of approval but has not yet applied for FDA approval. 3.2. The Bjork-Shiley single leaflet prosthesis Model: Bjork-Shiley tilting standard disc and convexoconcave (CC) disc. Type: Single leaflet, tilting disc. Technical information: Manufactured and marketed by Shiley This valve was introduced in 1969 with a Delrin (white) disc. The Delrin disc was replaced by a pyrolytic carbon coated graphite disc in 1971 and, in 1975, a marker ring was added to the disc. In 1975, the disk was modified to a spherical shape to reduce eddy flow. In 1975, the CC model was introduced to reduce the incidence of valve thrombosis in the minor orifice. In 1979, Pfizer purchased the rights to the Bjork-Shiley valves. This valve was taken off the North American market in 1986 due to a series of cases of strut fracture leading to disc dislodgement. In 1992, Sorin Biomedica Cardio bought the rights to the BjorkShiley valves (except the convexoconcave (CC) model). Size range and available dimensions: Sewing ring sizes: 17 33 (aortic), 17 33 mm for supra-annular (mitral) and sub-annular (mitral), and 17 31 mm for the intra-annular position (mitral) with orifice diameters being 12 24 mm for both aortic and mitral valves. Physical characteristics: The tilting disc (single leaflet) gave the valve its characteristic near central flow (Fig. 3A). In the CC model, the pyrolitic carbon coated disc is held in place by the large inflow and small outflow struts, which fits into the central depression of the disc (Fig. 3B). Poppet material: Pyrolytic carbon, Delrin (pre 1972). Housing and strut material: Haynes 25 (R) alloy. Sewing ring material: Teflon. Radiographic characteristics: The range of motion is 60 between the open and the closed position. A thin radiopaque ring is seen within the disc of valves sold post 1975 (Fig. 3C,D). Potential complications: Thrombus on the metal struts, orifice and prosthesis-tissue interface. Death (before they

Type: Single leaflet/tilting disc valve. Technical information: AorTech Europe (Strathclyde, UK) markets the Ultracor valve. This prosthesis obtained the CE mark in 1995 and in its first 4 years of implantation, approximately 14,000 valves have been implanted worldwide [18]. Size range and available dimensions: The AorTech Ultracor model is available with sewing cuff diameters ranging from 19 to 29 and 23 to 33 mm for the aortic and mitral sites, respectively. Physical characteristics: This design features a titanium housing machined from a single block to eliminate welds. A single strut and a centrally located pivot axis are designed to increase laminar blood flow (Fig. 2). The maximum opening angle for the valve is 73 and 68 for the aortic and mitral positions, respectively. The sewing ring is fabricated of knitted Teflon to promote rapid controlled ingrowth and minimize the risk of paravalvular leak [19]. Radiographic characteristics: Improved radiographic imaging is obtained from a plano-convex disc with a Pyrolite carbon coating on a tungsten-impregnated graphite substrate [18]. Special features: This valve is designed to facilitate implantation procedures and also allows for in situ rotation of the housing for maximum hemodynamic capabilities. In situ operation of the prosthesis is reported to be fairly quiet [19]. Potential complications: No structural failures were observed in two different studies on the Ultracor prosthesis [18,19], which evaluated a total of 540 patients. However, other common MHV complications were reported. For the Ultracor valve, freedom from thromboembolism at 5 years was reported as being 90% [19] and, according to a different report, 99% and 88% for the aortic and mitral positions, respectively [18]. Thrombosis, on the other hand, proved to be sparse in the Ultracor clinical datum. One study reports a

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Fig. 3.

could be operated upon) has been reported in approximately 50% of patients with thrombosis of the tilting disc [10]. Perivalvular leak, not related to calcification, is reported particularly with the aortic site valves and is apparently greater in the 19-mm size [20]. Thrombus and tissue overgrowth along the perimeter of the minor outflow region can further reduce the flow in this region [21]. Pannus on the sewing ring with extension onto the metal housing can lead to valve dysfunction and predisposition to thrombosis [20,22]. The incidence of infective endocarditis is similar to that of all other MHVs. Additional comments: The CC model was introduced to reduce thrombosis originating in the small orifice. It decreased the stagnation zone behind the disc and decreased emboli from 4.2% to 1.2% per year after mitral valve replacement (MVR) [23]. It was removed from the market in 1986 after reports of a series of outlet strut fractures leading to embolization of the disc. Close follow-up is recommended for all patients. Prophylactic removal is recommended in some patients with this series of valves, especially those with valve sizes greater than 29 mm. Very few if any more such cases have been reported in recent

years. Other factors considered are valve implant position, weld date, welder identity, valve shop order, body surface area and current age of patient [24,25]. FDA approval: Not approved by FDA (since 1986). 3.3. The Bjork-Shiley monostrut valve Model: Bjork-Shiley tilting disc with single outflow strut (monostrut). Type: Single leaflet, tilting disc. Technical information: Shiley first manufactured the Bjork-Shiley monostrut in 1981. Sorin Biomedica Cardio bought it in 1992 from Pfizer and then sold it to Alliance Medical Technologies. Size range and available dimensions: This valve was available in sewing ring sizes 17 33 mm with orifice diameters of 12 24 mm (aortic and mitral valves). Physical characteristics: The valve used a thin wafer disk to pivot into open and closed position. The hinge placement permitted a near central flow. The inlet strut was C-shaped. The single outlet strut fit into the central depression of the disc and held it in place.

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Fig. 4.

Poppet material: Graphite coated with pyrolytic carbon. Housing material: Haynes 25. Sewing ring material: Teflon or carbon-coated Dacron. Radiographic characteristics: The disc had a radiopaque rim. The housing, inlet strut (c-shaped) and outlet strut (single) are all radiopaque (Fig. 4B,C). Special features: The Bjork-Shiley Monostrut valve was machined from one piece of Haynes 25 alloy, eliminating the need for a weld and hence eliminating the possibility of strut fracture and disc embolization [26]. The valve had a CC disc made of pyrolytic carbon that opens to 70 to optimize performance across the valve. Potential complications: Thrombus can form on the metal orifice, struts and valve-tissue interface. The incidence of thromboembolism is comparable to that of other mechanical valves. Pannus forming over the valve-sewing ring can extend onto the valve housing and lead to valve stenosis or incompetence by restricting disc movement [27]. The risk of infective endocarditis is similar to other mechanical valves. Additional comments: The monostrut valve has a low rate of valve-related complications, a durable design, excellent hemodynamics and functional results [28]. A review of our

own series of mechanical valves shows that this monostrut prosthesis has the lowest incidence of complications (personal experience-JB). FDA: Approved in 1997 (Alliance Medical Technologies). This valve is no longer manufactured. 3.4. The Omniscience valve Model: Omnicarbon (R) (OC) and Omniscience (R) (OS). Type: Monoleaflet/pivoting disc (aortic, mitral). Technical information: Manufactured and sold by Medical CV (Inver Grove Heights, MN), the OC valve evolved in design from the OS valve. The OS and OC valves have been available on the international markets since 1978 and 1984, respectively. Size range and available dimensions: The OS valve has orifice diameters of 14.4 24.0 (aortic), 14.4 26.0 (mitral) and corresponding annulus diameters of 19 31 mm (aortic and mitral). The OC has annulus diameters of 19 33 mm (aortic and mitral) and corresponding orifice diameters of 14 24 mm (aortic and mitral). Physical characteristics: Omniscience

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Fig. 5.

Disc: Pyrolytic carbon with smooth proximal and distal surfaces. Housing: Nickel-free titanium (machined from one block). Sewing ring: Seamless PTFE knit fabric (polytetrafluoroethylene). The OS (Fig. 5A) was followed by the OC (Fig. 5B), which features a housing of pyrolytic carbon [29]. The pivots were shortened to provide a lower profile [30]. Omnicarbon Disc: Pyrolytic carbon with smooth proximal and distal surfaces. Housing: Smooth pyrolytic carbon. Sewing ring: Teflon. Radiographic characteristics: The housing and disc are both radiopaque. Special features: Both valves have two guards to guide a curvilinear disc. Maximum opening angle is 80 and closed angle is 12. Potential complications: As with other mechanical valves, the OS and OC have associated risks and complications. After isolated aortic valve replacement (AVR) with the OC, 10-year freedom from various complications was the following: thromboembolism 94.8%/patient year (pty), valvar thrombosis 95.0%/pty, anticoagulant-related hemorrhage 93.6%/ pty, prosthetic valve endocarditis 93.0%/pty and reoperation 90.6%/pty (n = 882.7 pty) [30]. After 12 years of AVR and MVR with the OS, respective freedom from various complications was: thromboembolism 85.5 5.0%/pty and 85.2 6.5%/pty, hemorrhage 92.3 3.0%/pty and 91.4 3.5%/pty, endocarditis 96.2 2.1%/pty and 98.8 1.2%/pty, perivalvular leak 95.0 3.0%/pty and 97.6 1.7%/pty, and pannus interference 98.7 1.3%/pty and 96.5 3.4%/pty (n = 1475 pty) [31]. A 1995 review paper by Akins in Boston, USA [32] reports incidence of anticoagulant-related complications for the OS as lowest compared to four other mechanical valves but includes a caveat due to the small number of patient follow-up years. In the same review, the OS was

reported to have the highest linearized rate of thromboembolism, nonstructural dysfunction and valve endocarditis. FDA approval: The OS and OC valves were FDA approved for clinical use in 1978 and 2001, respectively. 3.5. The Medtronic-Hall prosthesis Model: Medtronic-Hall A7700 (aortic) and M7700 (mitral). Type: Single leaflet/pivoting disc (aortic, mitral). Technical information: The Medtronic-Hall valve is manufactured and sold by Medtronic Inc. (Minneapolis, USA) and has been available since 1977 [11]. Size range and available dimensions: The MedtronicHall valve is available with sewing ring diameters of 20 29 (aortic), 23 31 (mitral), and corresponding orifice diameters of 16 24 (aortic) and 18 24 mm (mitral), respectively [11]. Physical characteristics: This valve encourages central flow through a large orifice-to-annulus ratio and low transvalvular gradients (Fig. 6A,B). Normal opening angles are 70 for the mitral and 75 for the aortic position. The valves closed angle is 0. Poppet: Pyrolytic carbon. Housing material: Titanium (machined from a single block). Sewing ring material: Knitted PTFE standard, knitted PET for the EZ FIT sewing ring option. Radiographic characteristics: The housing and disc are radiopaque and radiolucent, respectively (Fig. 6C,D). Potential complications: No mechanical failures have been reported at 9 (n = 502 prostheses) and 20 years (n = 1776 procedures) [33,34]. This design has excellent hemodynamics, good durability and low thrombogenicity [33,34]. Nitter-Hauge et al. [35] have found that the incidence of thromboembolism can be kept down to approximately 1% per patient-year if anticoagulant treatment is carefully monitored. Overall incidence of

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Fig. 6.

obstructive valve thrombosis was reported at 0.04% per year in another study [34]. Anticoagulant-related hemorrhage was negatively correlated with intensity of anti-

coagulation [35] and was most frequent in the early postoperative stage [34]. Preoperative patient status and postoperative care are major factors affecting the

Fig. 7.

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risk of infective endocarditis [34]. At 15 years, 99.7%/ pty of aortic valves (AV), 99%/pty of mitral valves (MV), 98%/pty of DVRs were free of reoperation for perivalvular leaks (n = 1766) [34]. In the same study, at 10 and 15 years, freedom from all valve-related complications was 72%/pty and 60%/pty for AV, 61%/pty and 50%/pty for MV and 61%/pty and 52%/pty for DVR, respectively [34]. Additional comments: The cage is free of welds and bends and the rotating central disc allows for uniform wear [11]. The sizes 20 22 mm Medtronic-Hall valves are deemed especially appropriate for patients with a small aortic annulus [36]. Recent studies have shown the eccentric design of the Medtronic-Hall valve to reduce turbulence and maximize hemodynamic performance when oriented to align with the eccentric flow in the native annulus. This

has been shown to give superior results to that possible with symmetrical bileaflet designs [37]. FDA approval: The Medtronic-Hall A7700 and M7700 valves, including the EZ FIT option are currently approved for clinical use in North America. 3.6. The Sorin Allcarbon tilting disc valve Model: Sorin Allcarbon, Monocast and Carbocast tilting disc. Type: Single leaflet tilting disc valve. Technical information: Monocast was the first tilting disc valve, made by Sorin, and used clinically in 1977. Sewing ring was coated with a carbon film in Carbocast (1986). In addition, Allcarbon (1988) has a Carbofilm (TM)-coated housing.

Fig. 8.

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Size range and available dimensions: The valve is available in sewing ring sizes 19 31 (aortic) and 19 33 mm (mitral) with orifice diameters of 14 24 mm for both aortic and mitral valves. Physical characteristics: The housing is made of Stellite 25 (Haynes 25, Alacrite XSM), a chrome-cobalt alloy, with droplet shaped struts, using a microcasting process to eliminate any welds. The graphite substrate of the disc is coated with pyrolytic carbon. The sewing ring is coated with a thin film of turbostatic carbon (Fig. 7A). Poppet material: Pyrolytic carbon over a graphite substrate. Cage material: Haynes (R) HS25 (Stellite 25, Alacrite XSM (R)). Sewing ring material: Teflon. Radiographic characteristics: The disc has a tantalum wire that is radiopaque. The range of motion is 60 from open to closed position. Special features: The inflow and outflow portions of the sewing ring are coated with Carbofilm to improve hemocompatibility and reduce the risk of tissue overgrowth (Fig. 7A). The central portion, intended for contact with tissue annulus, does not have this coating. According to the manufacturer, this feature is intended to promote tissue growth. The struts are droplet shaped to provide an optimal hydrodynamic contour to reduce turbulence and thrombogenicity. Potential complications: Thrombus can form on the fabric, struts and interface of valve and tissue. The incidence of thromboembolism is low and comparable to other mechanical prosthesis [38]. Pannus grows on the sewing cuff (valve-tissue interface) and can lead to stenosis of the valve [39]. Periprosthetic leak is the most common cause of nonstructural dysfunction seen [40]. The risk of infection is similar to other mechanical valves. Additional comments: CE Mark for sale in Europe. The Sorin tilting disc valve was also available as a Monostrut model (Monostrut X) (Fig. 7B). FDA approval: Not approved.

Fig. 9.

4. Bileaflet 4.1. The advancing the standard (ATS) open pivot bileaflet valve Model: ATS open pivot bileaflet valve standard series and ATS open pivot bileaflet AP (advanced performance) series. Type: Bileaflet valve; aortic and mitral positions. Technical information: Manufactured and sold by ATS Medical; the standard series is designed for intra-annular placement; the AP series is designed for the supra-annular position [41]. Size range and available dimensions: Standard series (Fig. 8A,C) aortic: 19 31 mm, mitral: 19 33 mm [42]. AP series (Fig. 8D) aortic: 16 28 mm, mitral: 16 20 mm [42].

Physical characteristics: The open pivot valves (standard and AP series) have central flow. Orifice ring: Pyrolytic carbon [43]. Leaflets: Pyrolytic carbon over graphite substrate impregnated with 20% tungsten by weight [41]. Sewing ring material: Double velour Dacron to promote controlled tissue ingrowth [43], with Teflon insert to increase materials pliability [41]. The rotation ring is made of titanium [43]. Radiographic characteristics: The leaflets have increased visibility due to high tungsten content of the discs substrate. The titanium rotation ring is also radiopaque [43]. The flat titanium ring profile of the ATS valve (Fig. 8B) is similar to that of some Carbomedics models (Fig. 14I,J). Special features: In contrast to other bileaflet prostheses (Fig. 9B), the pivot area is not cavitied in the ATS models (Fig. 9A) [32]. The ATS design features a reverse geometry at the hinge points creating four semi-spheres that project into the blood stream. ATS Medical claims this design promotes better washing and decreased stasis, thus, decreasing the incidence of thrombus and thromboembolism. Additional features include a reputedly decreased valvular noise level when closing, low profile structure and pre-mounted design [41]. Potential complications: The ATS open pivot bileaflet valve has an incidence of complications similar to that of other bileaflet valves [43,44]. In-vitro studies indicate that the

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ATS bileaflet valve does not open to the full 85 it was manufactured to attain, which may explain why the same studies report that the valve closes extremely quickly [45]. This failure to open fully may also explain the reduced closing noise reputed to be a feature of this valve. The long-term effects of the suboptimal opening are not fully understood [45]. Overall, at this early follow-up stage, the ATS open pivot bileaflet valve has shown decreased levels of thrombosis and hemolysis when compared to some earlier model valves. There have been no structural changes reported, and reduced transvalvular gradients have been measured [44]. FDA approval: The first clinical trial of the ATS valve was in May of 1992, and the valve received FDA approval in October 2000 [44]. 4.2. The Edwards bileaflet valves Models: Edwards-Duromedics valve (discontinued) (AKA TEKNA). Type: Bileaflet valve.

Technical information: Introduced by Hemex Scientific in 1982 and subsequently acquired by Baxter Healthcare [46]. In 1988, Baxter Healthcare voluntarily withdrew the valve (Fig. 10A) from the market citing 12 leaflet escapes out of a total of 20,000 implants [47]. In June of 1990, the valve was reintroduced to the market as the revised Edwards-Duromedics, and later still as the Edwards Tekna valve. These valves are no longer on the market. 4.3. Edwards Mira (R) valve The present Edwards Bileaflet valve is the Mira (R) Valve (Fig. 10B). The mechanical components of the Mira valve are manufactured by Sorin Biomedica (Italy). It differs from the Sorin bileaflet Bicarbon in that the sewing ring is softer and waffled, and has a Silicone insert. This makes the cuff similar to the Starr-Edwards valve. This sewing cuff is meant to increase the ease of implantation. Size range and available dimensions: Model 3160 in aortic position: 19 27 mm. Model 9210 in mitral: 25 33 mm [48]. Physical characteristics: Central blood flow.

Fig. 10.

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Orifice ring: Pyrolytic carbon with a stiffener ring composed of Stellite [48]. Leaflets: Pyrolytic carbon over graphite substrate impregnated with tungsten [48]. Sewing ring material: Dacron, with or without Biolite coating [48]. Radiographic characteristics: The stiffener ring is completely radiopaque. Leaflets are somewhat visible due to the tungsten-impregnated substrate (Fig. 10C,D). Characteristic curved leaflets can be seen on X-ray, but are more visible in certain orientations [48]. Special features: Special features include curved leaflets that provide three equivalent orifice areas, rotational ability once implanted and a self irrigating hinge mechanism where the leaflets join the body of the valve [49]. Potential complications: The main complication with the original series (Duromedics) of valves was leaflet escape. By December 1995, 46 cases of leaflet escape had been reported, which correlated to an estimated linearized rate of 0.029%/ pty [46]. After removing the valve from the market, Baxters corporate investigations implicated five reasons for leaflet escape: (1) clustered microporosity (2) cavitation bubbles, (3) dimensional tolerances, (4) insufficient compliance of the sewing ring and (5) surgical mishandling [49]. Of these complications, Baudet et al. [49] cited surgical mishandling as being the most significant for leaflet escape. This was in contrast to Mastroroberto et al. [46] and Hemmer et al. [47] who implicated cavitation as the most common cause of leaflet fracture. Leaflet escape notwithstanding, this valve shows excellent hydrodynamic performance [49]. Regardless of the etiology, when the valve was reintroduced in 1993, the company made several improvements to the design to attempt to avoid these complications. Of these, the most notable include an improvement to the shock absorber in the sewing ring and a more sophisticated quality control procedure for making pyrolytic material [50]. Even with the information present regarding failure of some of the Edwards-Duromedics valves, the recommendation cannot be given to have prophylactic re-replacement of the prosthesis [50]. This conclusion was reached by taking into account both the data collected and the operative mortality of valve replacement, especially in the mitral position [50]. This is in contrast to certain diameters and dates of production of the BjorkShiley CC prosthesis [50]. FDA approval: The Edwards-Duromedics and the Tekna valves have been withdrawn from the market. The MIRA valve (Fig. 10B) received its European CE mark in 1998, was licensed in Canada in 2000 and is in FDA clinical trials in the United States. 4.4. The On-X and Conform-X valves by MCRI

the valve (Fig. 11A F) are designed for supra-annular sewing ring placement with intra-annular housing placement [51]. Size range and available dimensions: Aortic: 19 29 mm, mitral: 23 33 mm [51]. The On-X Conform-X valve (Fig. 11F) has a flexible cuff that conforms to the dimensions of annulus. This cuff allows one valve size to be used for all annulus sizes between 25 and 33 mm [51]. Physical characteristics: Central blood flow (Fig. 11A,B). The pyrolytic carbon used by MCRI is not alloyed with silicon, as it is in other valves that utilize pyrolytic carbon. MCRI calls this new, purer pyrolytic carbon OnX carbon. The On-X carbon is meant to reduce thrombogenicity while increasing the strength and durability of the material [51]. Orifice ring: On-X carbon. Leaflets: On-X carbon over a graphite substrate with 20% tungsten by weight. Sewing ring material: Polytetrafluoroethylene (PTFE) [51]. The sewing ring is attached to the valve using a titanium-retaining band (Fig. 10A C). Radiographic characteristics: The leaflet substrate is impregnated with tungsten to aid X-ray visibility. The titanium-retaining band to which the sewing ring is attached is also radiopaque (Fig. 11C E). The aortic valve has two rings (Fig. 11D). Special features: The On-X valves feature a unique carbon design that is reported to have better mechanical properties than the original pyrolytic carbon [52]. Other salient features include the butterfly-like hinge configuration, flared and elongated orifice inlets and thin leaflets to promote more effective hemodynamics [53]. The elongated orifice reduces the total angle that the leaflets must travel, thus the regurgitant closing volume is effectively minimized and the leaflet impact velocity at closure is diminished [51]. The intra-annular flare design and leaflet guards (Fig. 11A,B) provide a physical barrier to protect against tissue encroachment [51]. Potential complications: Because the On-X valve is still very new (especially in the North American market), little documentation of potential complications is available. Short-term studies on the valve seem positive, and compare favorably to other bileaflet valves [52]. Walther et al. [52] have reported some problems with valve sizing due to the elongated housing and the flared inlet. This may become more critical for the inexperienced surgeon. FDA approval: On-X clinical trials began in September 1996 in Germany. The valve received FDA premarket approval for the aortic prosthesis in May 2001 and for the mitral and Conform-X valves in March of 2002 [51]. 4.5. The Sorin Bicarbon mechanical valve

Models: The On-X aortic, mitral and the Conform-X valve. Type: Bileaflet valve. Technical information: Manufactured and sold by the Medical Carbon Research Institute (MCRI). All series of

Model: Sorin Bicarbon ART19LN to ART31LN/ ART19LNF to ART31LNF (aortic), MTR19LS to MTR33LS/MTR19LNF to MTR33LNF (mitral).

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Fig. 11.

Type: Bileaflet mechanical valve. Technical information: The Bicarbon valve is manufactured and distributed by Sorin Biomedica Cardio (Saluggia, Italy). This prosthesis has been available on the European market since 1990 [54]. Size range and available dimensions: The standard Sorin Bicarbon model is available with sewing cuff

diameters ranging from 19 to 31 mm and 19 to 33 mm for the aortic and mitral sites, respectively. The Sorin Bicarbon Fitline valve, which features a reduced sewing cuff to facilitate implantation, is also available in these same dimensions. Physical characteristics: This prosthesis design features two curved pyrolytic carbon covered leaflets intended to

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Fig. 12.

enable laminar blood flow (Fig. 12A,B). The hinge mechanism consists of a rolling pivot design to minimize wear and the housing is of a titanium alloy (Ti6Al4V) coated with Carbofilm to ensure low thrombogenicity. The sewing cuff, made of a double-velour PET and PTFE fabric, is also coated with a thin layer of Carbofilm. Radiographic characteristics: The Sorin Bicarbon valve has an 80 opening angle (55). The leaflets and housing are radiopaque (Fig. 12C). Special features: This valve utilizes an aerofoil leaflet design that is meant to minimize turbulence and stagnation. The curved leaflets also allow for three hydrodynamically equivalent streamlines, which further enhance the hemodynamics of the valve [56]. In addition, the hinge mechanism is designed to allow a small degree of backflow near the hinges to increase backwash of this area and reduce the risk of thrombosis, even when the valve is in the closed position [56]. Potential complications: Through its 12 years of implantation, there have been no reports of mechanical

failure [57]. However, studies have reported wear behavior in relation to the Carbofilm coating on the valve housing in the hinge areas [54,58,59]. This wear has not been significant enough to cause dysfunction. The Bicarbon valve appears to have a low degree of thrombogenicity. One report suggests that this prosthesis has an actuarial freedom from thrombosis at seven years of 99 1% (aortic), 97 3% (mitral) and 98 1% (aortic and mitral) (60), while another report claims an overall five year freedom from thrombosis of 99.2 0.3% [57]. Bleeding complications proved to be slightly more important; Bortolotti et al. [60] report a freedom from bleeding at 7 years of 91 3% (AV), 86 7% (MV) and 82 13% (DV), while Borman et al. [57] report a freedom at 5 years of 95.5 1.0%. Mecozzi et al. [61] believe that the design, specifically the curved profile of the leaflets, account for the lower severity of hemolysis than in the Carbomedics prostheses. Infective endocarditis remains an important complication in this, as in other MHVs. Freedom from endocarditis at

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seven years has been reported as 99 1% (AV), 99 1% (MV) and 95 1% (DV) [60], while another study reports a slightly higher incidence of endocarditis with freedom from endocarditis at 5 years of 90.9 4.6% [57]. Freedom from all valve-related complications at 7 years has been reported at 80 5% (AV), 73 1% (MV) and

34 18% (DV) [60] and the linearized incidence of valverelated complications at 8.02%/pty (MV) [55]. Additional comments: Sorin Biomedica has a new Bicarbon Slimline valve designed for supra-annular placement. This valve differs from the standard model in that it has a smaller sewing cuff, allowing implantation of a larger valve

Fig. 13.

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Fig. 13. (continued )

in a given annulus. This new design reportedly minimizes pressure gradients and increases the effective orifice area (EOA), thus improving overall hemodynamics. FDA approval: The Sorin Bicarbon valve is not yet FDA approved. It is currently under clinical investigation in the USA and marketed elsewhere with European CE mark approval. 4.6. The St. Jude Medical (SJM) bileaflet mechanical valve Models: SJM standard mechanical valve. Also, SJM Expanded series, SJM Hemodynamic Plus (HP) series, SJM Masters series, SJM Regent Valve and SJM Masters series with Silzone (SZ) coating (see Section 4.7). Type: Bileaflet; aortic, mitral and tricuspid. Technical information: Manufactured and sold by SJM Regent Valves (St. Paul, MN, USA). The SJM standard bileaflet valve (Fig. 13A C) was introduced clinically in 1977 [11], while the Expanded series was introduced in March 1996 (USA), the HP series in 1996 (Fig. 13G), the Masters series (Fig. 13E) in 1995 (USA), the Regent valve

(Fig. 13D) in February 1999 (March 2002 in the US) and the SJM Silzone (Fig. 13F) was introduced in 1997 in Canada and Europe and in the USA in August 1998. Size range and available dimensions: SJM bileaflet valves (Fig. 13A,B), SJM regent valves (Fig. 13D) and the HP series (Fig. 13G) are available with mounting diameters of 17 31 (aortic), 17 31 (mitral) and corresponding orifice diameters of 14.7 26 mm (aortic and mitral) [11]. Overall open height is 8.4 12.2 mm for all aortic and mitral SJM bileaflet valves [62]. Physical characteristics: In vitro studies show that flow through all SJM mechanical valves is symmetric and relatively nonturbulent [11]. In vivo mean pressure gradients range from 3.0 to 5.2 mm Hg in the aortic position and from 1.4 to 7.0 mm Hg in the mitral position [63]. Regurgitant volume ranges from 7.6 to 10.6 cm3/stroke for aortic valves and 4.3 to 6.4 cm3/stroke for mitral valves [63]. The valve housing and leaflets are constructed of graphite coated with pyrolytic carbon. In addition, the leaflet substrates are impregnated with tungsten (5 10 wt.%) to ensure adequate radio-opacity (Fig. 13C) [11]. Leaflet hinge

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configuration is a butterfly-like depression and pivot guards are upright. The sewing cuff is made of polyester PET or PTFE [62]. Design differences between the various valve series are outlined below. Expanded series: 10% more sewing cuff material for mitral valves and 25% more for aortic valves, with no change to either mounting or orifice diameters. HP series: Supraannular sewing cuff with intraannular carbon rim (Fig. 13G). HP series eliminates sewing cuff material in the annulus and increases geometric flow area by up to 26% [62]. HP series valves open fully to an angle of 85, hence with a large effective orifice area, lower mean pressure gradients, and hemodynamic performance considered equivalent to that of the next larger size of standard cuffed valve [64,65]. Masters series: The main design difference of this series is the addition of a controlled torque rotation mechanism and additional suture markers, both of which facilitate implantation [62]. Aortic models are available with standard, expanded or HP sewing cuffs while the mitral models are available with the standard or expanded sewing cuff (Fig. 13E). In addition, Masters series HP valves are available with either the standard HP cuff or with a FlexCuff sewing ring. The FlexCuff ring is flanged and more pliable than other SJM sewing cuffs. Regent valve: This series has the same design as the Masters series with two exceptions: the carbon rim is shifted to the supraannular position along with the sewing cuff, and the rotation mechanism is housed completely within the carbon rim (Fig. 13D). Hemodynamically, this series has an approximate one-size increment (improvement) over HP series valves. Regent valves are available with either the standard or the FlexCuff sewing ring. Radiographic characteristics: The valve housing is made of pyrolytic carbon and is radiolucent in the standard model. The leaflets are visible in the fully open position as radiopaque lines. A radio-opaque lip-shaped inner design with sharply defined midline lucent stripes corresponding to the valve leaflets is seen in Fig. 13C [11]. The rotation mechanism of the Masters series valve, like the Silzone model, appears as an opaque double ring (Fig. 13H,I). This allows the surgeon to change the orientation of leaflets after implantation [62]. Potential complications: A loss of structural integrity has been reported for a small number of SJM mechanical valves (approximately 15 20 out of 9514), including one incident of post-operative leaflet dislodgment [32]. The most common nonstructural complication of the SJM mechanical valve is thromboembolism with a reported rate of 2.0 events per pty for aortic valves (n = 17,242 pty) and 2.5/pty for mitral valves (n = 17,696 pty) [32]. Rates of anticoagulation-related complications in patients with SJM valves were reported as 2.2/pty (n = 14,845) for aortic valves and 1.7/pty (n = 16,679) for mitral valves [32]. Obstruction of mechanical valves due to thrombus or pannus formation is a rare but life-threatening complication that should not be disre-

garded when dealing with bileaflet valves. The rate of pannus formation on SJM mechanical valves has been quoted as 0.03 0.14%, and pannus is more likely to be seen on valves in the mitral or tricuspid position (n = 18,523 pty). Acute prosthesis thrombosis is mostly a complication of inadequate anticoagulation, more specifically poor patient compliance, but has been related to pannus formation [66]. Infective endocarditis is a risk for all types of prosthetic valves, and rates for SJM mechanical valves are reported as 0.2 0.4 cases per patient year [32]. Additional comments: The SJM standard bileaflet prosthesis is the gold standard against which most other mechanical valves are compared. It is the most frequently implanted MHV prosthesis worldwide. FDA approval: All SJM mechanical valves discussed above, except the SJM SZ valve (see below), are currently approved for clinical use in North America and the EU. The SJM SZ bileaflet mechanical valve was voluntarily withdrawn from the market in January of 2000. 4.7. SJM bileaflet mechanical valve with Silzone coating Model: SJM Masters series with Silzone (SZ) coating. Type: Bileaflet; aortic and mitral. Technical information: Manufactured and sold by SJM (St. Paul, MN, USA). The SZ coating was first introduced in Europe (and Canada) in September 1997 and in the USA in May 1998. SJM initiated a voluntary withdrawal of all SZ valves (and annuloplasty rings) in January 2000. Size range and available dimensions: same as for the non-SZ SJM Masters series valves (see above). Physical characteristics: Basic valve design and flow characteristics are the same as those described for Masters series valves (see above) (Fig. 13F). Features of the SJM Masters series with SZ coating include: Leaflet material: Pyrolytic carbon with graphite substrate impregnated with tungsten, 5 10% by weight. Cage material: Pyrolytic carbon over graphite substrate. Sewing ring material: PET polyester coated with metallic silver by an ion beam-assisted vapor deposition process [67]. Radiographic characteristics: Same as for non-SZ Masters series valves (see above) (Fig. 13H,I). Potential complications: The potential complications associated with SZ valves are as described for non-SZ SJM valves (see above). In addition, the SZ valves were associated with a higher rate of major paravalvular (PV) leakage as compared with non-SZ valves. Major PV leak is defined as PV leak that resulted in explant, required reoperation or was implicated in a death [68,69]. It has been hypothesized that this increased risk of PV leak may be due to an inhibition of normal fibroblast response and incorporation of the fabric of the sewing cuff into host tissues in some patients [68]. In another study, freedom from PV leak at 12 and 24 months follow up was 98.5% 1.5% and 100% for the aortic and mitral valves, respectively [70]. One

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observational study also reported a higher rate of embolic complications with SZ valves and concluded that the SZ coating is more thrombogenic [68,71]. Mortality rates have varied between centers. Data from the AVERT study have so

far not shown any significant increase in mortality [68,69]. A case of left atrial rhabdomyosarcoma was reported in a patient who had undergone a MVR with a Silzone-coated SJM MHV 1 year earlier [72].

Fig. 14.

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Fig. 14. (continued )

Additional comments: The SZ coating was introduced with the hope that the silver layer would prevent bacterial colonization of the valves and consequent prosthetic valve endocarditis. The SZ fabric was shown to reduce attachment and colonization of microorganisms such as Staphylococcus aureus, S. epidermidis, Escherichia coli, Klebsiella pneumo-

niae and Candida albicans in cell-culture and animal studies [67,73]. FDA approval: SJM initiated a voluntary withdrawal of all valves (and other devices) with the SZ coating in January of 2000 following reports of significantly higher rates of PV leak as compared to non-SZ SJM valves. FDA approval was

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subsequently withdrawn and the SZ coating is no longer in clinical use. 4.8. The Sulzer CarboMedics valves Models: (A) Standard (Fig. 14A); (B) R series reduced cuff aortic (Fig. 14B); (C) OptiForm Mitral (Fig. 14E); (D) Pediatric-small adult; (E) Top Hat supra-annular aortic (Fig. 14A E). Type: Bileaflet valves. Aortic (Models A, B, D and E) and mitral (Models A, C and D). Technical information: The CarboMedics prosthetic heart valve (CPHV) is manufactured by Sulzer CarboMedics, Austin, TX and was introduced in 1986. The leaflet pivot design is believed to allow thorough washing of the hinge mechanism but incomplete wiping of the hinge surfaces. The mitral valve is implanted intra-annularly. The small mitral-21 mm (model D) is designed for intra-annular or intra-atrial implant. The Top Hat is the first bileaflet mechanical valve designed for truly supra-annular placement (74). Its small size and placement position makes it possible for the surgeon to use a prosthesis that is one size larger than would be permissible with an intra-annular valve [75]. This advantage is especially important in patients with a small aortic root. A contraindication would be coronary ostia that are displaced downwards. Based on its one size-up feature, this model is believed to provide a potential increase in valve flow area along with a reduction in pressure gradients [74]. Size range and available dimensions: Aortic valves: 19 31 mm, mitral valves: 23 33 mm. The R Series is truesized to eliminate sizing conflicts and downsizing. Valve sizes are 19 29 mm with respective internal orifice diameters ranging from 18.8 to 29.0 mm. Pediatric-Small Adult aortic valve sizes range from 16 to 19 mm and mitral from 16 to 21 mm. Physical characteristics: All CPHVs are made of Pyrolite. Pyrolytic carbon-coated discs pivot inside a pyrolytic carbon housing into which the valve hinges are recessed. The flow surface of the Dacron sewing cuff is coated with Biolite Carbon (R) (black). A titanium ring surrounds the valve housing and allows rotation of the valve for optimal orientation after implantation. The two leaflets open to 78 from the horizontal axis. The valve discs seat closer to the edge of the housing. In the aortic position both discs of the CPHVs open uniformly and remain in the open position during systole [76]. The 21-mm Pediatric-Small Adult mitral valve has a unique cuff design made of polyester knit fabric. Radiographic characteristics: The titanium ring surrounding the valve housing and the leaflets are radiopaque (Fig. 14F,G). CPHVs have two main types of ring profiles. The Standard mitral and aortic models have a humped profile (seen as a slight hump at the inflow end on Fig. 14H). The opening in the metal ring where the wire is inserted to secure the carbon housing is seen as a small dark gap on one side of the profile. The second ring profile is the flat profile. This profile is used for the pediatric valves, the R-Series aortic

(Fig. 14I), the Optiform mitral (Fig. 14J) and the Orbis valve. The flat ring profile is also seen on the ATS valves. Special features: The mitral valve has a soft pliant sewing cuff that conforms to the annulus and shields the leaflets and outflow area from interference by native mitral tissues. The aortic valve has a pliable cork-shaped sewing cuff that helps minimize perivalvular leaks. The R Series has a reduced outer diameter with no change in the internal orifice diameter, allowing the largest intra-annular valve (29 mm) in patients with narrow aortic annuli. This feature minimizes the need for annuloplasty. The OptiForm has a symmetrical compliant sewing cuff design that conforms to the patients annulus and seals around the native annulus. This gives the surgeon a choice of valve placement by varying needle entry and exit sites. The Pediatric-Small Adult model has a smaller sewing cuff that allows implantation of a 19-mm housing in a patient with a 16-mm tissue annulus. This provides the increase in blood flow and hemodynamic requirements as the patient grows and may minimize the need for repeated valve replacement in the growing heart [77]. Its small size and supra-annular placement allows the surgeon to upsize the valve by 2 4 mm, minimizing the need for annulus enlargement procedures [78,79]. Potential complications: CPHVs have higher reported static leak rates when compared to other valves such as the Starr-Edwards, Omniscience and Medtronic-Hall [76]. Similar mortality and linearized rates of possible complications have been reported by different studies with a comparable number of patient-years (pty). Early mortality rates reported were 5.0% (n = 4040 pty) [80] and 5.6% (n = 4765.0 pty) [81]. A study on a Japanese population revealed a lower early mortality rate of 1.2% (n = 2016 pty) [82]. Linearized rates of complications reported by Fiane et al. [80] (n = 4040 pty) and Dalrymple-Hay et al. [83] (n = 4342 pty) were major thromboembolism at 0.9%/pty and 2%/pty, valve thrombosis at 0.2%/pty and 0.14%/pty, and prosthetic valve endocarditis at 0.1%/pty and 0.18%/pty, respectively. The incidence of paravalvular leak needing reoperation was reported as 0.5%/pty by Fiane et al [80]. Additional comments: There is an additional CarboMedics bileaflet model, the Orbis Universal (R), that is not as yet approved by the FDA. It is available in sizes 21 33 mm that can be adapted to either the mitral or aortic position. The valves subassembly is identical to other CPHVs with a titanium-reinforced ring. Its sewing ring is fabricated from a knitted polyester fabric. FDA approval: 1993. Closing comments: In this paper, we have given details of a select group of MHV prostheses most of which are currently being implanted, while some, though no longer in use, will continue to be explanted in significant numbers for years to come. In an occasional valve model, a relatively small number were implanted, however the cause of valve-failure and subsequent withdrawal from the market has not yet been established. We hope that proper identification of these

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J. Butany et al. / Cardiovascular Pathology 12 (2003) 322344 and vascular grafts made of artificial materials. In: Silver MD, editor. Cardiovascular pathology. New York: Churchill Livingstone, 1991. pp. 1489 545. Sakata K, Ishikawa S, Ohtaki A, Otani Y, Suzuki M, Kawashima O, Morishita Y. Malfunctioning Starr-Edwards mitral valve 21 years after installation. J Cardiovasc Surg (Torino) 1997;38:81 2. Machler HE, Schmidt CH, Neuner P, Iberer F, Anelli-Monti M, Dacar D, Rigler B, Kraft-Kinz J. Twenty-four years implant duration of the aortic Starr-Edwards silastic ball prosthesis: a valve of the past? Eur J Cardio-thorac Surg 1993;7:114 6. Hylen JC, Kloster FE, Herr RH, Hull PQ, Ames AW, Starr A, Griswold HE. Phonocardiographic diagnosis of aortic ball variance. Circulation 1968;38:90 102. American Edwards Laboratories Clinical Data report. 1983. Ref type: Pamphlet. Li HH, Jeffrey RR, Davidson KG, Seifert D, Korfer R, Grunkemeier GL. The Ultracor tilting disc heart valve prosthesis: a seven-year study. J Heart Valve Dis 1998;7:647 54. Sin YK, Campbell K, Pillai R. The Ultracor tilting disc heart valve prosthesis in the aortic position: mid-term follow up. J Heart Valve Dis 2000;9:688 92. Alvarez L, Escudero C, Figuera D, Castillo-Olivares JL. The BjorkShiley valve prosthesis. Analysis of long-term evolution. J Thorac Cardiovasc Surg 1978;104:1249 58. Yoganathan AP, Corcoran WH, Harrison EC, Carl JR. The BjorkShiley aortic prosthesis: flow characteristics, thrombus formation and tissue overgrowth. Circulation 1978;58:70 6. Cleveland JC, Lebenson IM, Dague JR. Early postoperative development of aortic regurgitation related to pannus ingrowth causing incomplete disc seating of a Bjork-Shiley prosthesis. Ann Thorac Surg 1982;33:496 8. Bjork VO, Henze A. Ten years experience with the Bjork-Shiley tilting disc valve. J Thorac Cardiovasc Surg 1979;78:331 42. Walker AM, Funch DP, Sulsky SI, Dreyer NA. Patient factors associated with strut fracture in Bjork-Shiley 60 degrees convexo-concave heart valves. Circulation 1995;92:3235 9. Schondube FA, Althoff W, Dorge HC, Voss M, Laufer JL, Chandler JG, Messmer BJ. Prophylactic reoperation for strut fractures of the Bjork-Shiley convexo-concave heart valve. J Heart Valve Dis 1994; 3:247 53. Bjork VO, Lindblom D. The Monostrut Bjork-Shiley heart valve. J Am Coll Cardiol 1985;6:1142 8. Alajmo F, Perna AM, Calamai G, Nigro R, Cassai M, Montesi G, Braconi L, Borgioli A, Preziuso M, Palminiello A. [Mitral valve replacement with the Bjork-Shiley monostrut prosthesis: a 4-year clinical experience]. G Ital Cardiol 1990;20:44 9. Aris A, Padro JM, Camara ML, Lapiedra O, Caralps JM, Borras X, Carreras F, Pons-Llado G. The Monostrut Bjork-Shiley valve. Seven years experience. J Thorac Cardiovasc Surg 1992;103:1074 82. DeWall RA, Qasim N, Carr L. Evolution of mechanical heart valves. Ann Thorac Surg 2000;69:1612 21. Abe T, Kamata K, Kuwaki K, Komatsu K, Komatsu S. Ten years experience of aortic valve replacement with the omnicarbon valve prosthesis. Ann Thorac Surg 1996;61:1182 7. Teijeira FJ. Long-term experience with the omniscience cardiac valve. J Heart Valve Dis 1998;7:540 7. Akins CW. Results with mechanical cardiac valvular prostheses. Ann Thorac Surg 1995;60:1836 44. Beaudet RL, Nakhle G, Beaulieu CR, Doyle D, Gauvin C, Poirier NL. Medtronic-Hall prosthesis: valve related deaths and complications. Can J Cardiol 1988;4:376 80. Butchart EG, Li HH, Payne N, Buchan K, Grunkemeier GL. Twenty years experience with the Medtronic Hall valve. J Thorac Cardiovasc Surg 2001;121:1090 100. Nitter-Hauge S, Abdelnoor M, Svennevig JL. Fifteen-year experience with the medtronic-hall valve prosthesis. A follow-up study of 1104 consecutive patients. Circulation 1996;94:II105 8.

prostheses and documentation of the findings from series of prostheses will help elucidate their modes of failure.
[14]

Acknowledgments
[15]

We gratefully acknowledge Ms. Melissa Skarban for her help in preparing this manuscript. We thank ATS valves, Edwards Life Sciences, Medtronic Heart Valves Division, Sorin Biomedica and St. Jude Medical for assistance with technical information, illustrative material either in electronic or hard copy photographs or the use of their websites on which illustrative material and technical data were available. We are particularly thankful to Ms. Sandra Schlehuber and Prof. Martin Guenther who graciously allowed us to use illustrations from their collection entitled Herzklappen Museum Mechanisch and ATS for the use of Fig. 9 (A&B). JB is a financially compensated consultant for St. Jude Medical. JB has, in the past, also been a financially compensated consultant to Sulzer CarboMedics, Medtronic (Canada), and Medical Carbon Research Institute. MSA received a summer scholarship from the University Health Network-Department of Pathology, while CM, CF and PB received summer scholarships from the UHN-Dept. of Pathology and the University of Toronto.

[16]

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