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Ann Thorac Surg 2001;71:78-85
© 2001 The Society of Thoracic Surgeons


Original article: cardiovascular

Valvuloplasty with glutaraldehyde-treated autologous pericardium in patients with complex mitral valve pathology

Choi-Keung Ng, MDa, Joachim Nesser, MDa, Christian Punzengruber, MDb, Otmar Pachinger, MDc, Johannes Auer, MDa, Herbert Franke, MDa, Peter Hartl, MDa

a Department of Cardiovascular Surgery, General Hospital Wels, Wels, Austria
b Department of Cardiology, General Hospital Wels, Wels, Austria
c Department of Cardiology, University Clinic Innsbruck, Innsbruck, Austria

Accepted for publication August 24, 2000.

Address reprint requests to Dr Ng, Department of Cardiovascular Surgery, General Hospital Wels, Grieskirchnerstr 42, A-4600 Wels/OOe, Austria
e-mail: verwaltung{at}khwels.at


    Abstract
 Top
 Footnotes
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 References
 
Background. Severe mitral regurgitation associated with complex mitral valve disease often precludes successful surgical repair. The feasibility and the results of valvuloplasty with glutaraldehyde-treated autologous pericardium remain largely unknown.

Methods. The cases of 63 patients who underwent operation within an 11-year period were studied. A pretreated autologous pericardial patch was used for leaflet extension plasty, for paracommissural plasty, as a substitute for part of the leaflet, and for reimplantation of ruptured papillary muscles to eliminate severe mitral regurgitation. Patients with a severely calcified annulus after en bloc decalcification had straddling endoventricular pericardial patch annuloplasty for reconstruction of the affected atrioventricular groove. Chordal replacement with a strip of pericardium was chosen if no suitable chordae were available. Pericardium-reinforced suture annuloplasty was used in patients with acute endocarditis resistant to medical therapy. Associated valvuloplasty procedures with Carpentier techniques were also employed.

Results. There were no operative deaths in this series. At a mean follow-up of 61.1 months (range, 4 to 132 months), mitral regurgitation was absent or trivial in 92.1% of patients by echocardiography. Freedom from reoperation was 95.2% at 1 year and 5 years. Thromboembolic events have not been detected. Thirty percent of patients returned to sinus rhythm. Two patients required valve replacement.

Conclusions. Our beneficial results indicate that glutaraldehyde-treated autologous pericardium is suitable for valvuloplasty. It provides durable and predictable repair of valves that might otherwise need to be replaced because of the complex mitral valve disease. The technique is reliable, allows further efficacious repair possibilities, and improves postoperative outcomes. Whether it can prevent late deterioration and calcification requires more investigation.


    Introduction
 Top
 Footnotes
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 References
 
Mitral valvuloplasty is an established therapeutic modality [1, 2] for the surgical treatment of mitral insufficiency. The use of valvuloplasty is dependent to a large extent on the underlying disease processes of the mitral valve. In most large series, mitral valve prolapse of the posterior leaflet secondary to myxomatous degeneration is treated by quadrangular or triangular resection. However, complex mitral valve pathological processes such as extensive calcification of the annulus with extension into the myocardium (Fig 1A), active infective endocarditis with tissue destruction (Fig 2A), severe fibrotic shrinkage of the leaflets and the attached chordae (Fig 3A), bileaflet prolapse accompanied by multiple lesions (Fig 4A), commissural prolapse or ischemic papillary muscle dysfunction or rupture (Fig 5), and posttraumatic lesions often create a myriad of obstacles to successful mitral valve repair. A frequent reason for failed surgical repair is the lack of sufficient leaflet tissue or adequate synthetic or biological materials (Figs 1B, 2C; see Figs 3A, 4A).



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Fig 1. (A) Curved bar of calcium resected from posterior leaflet. (B) After en bloc decalcification, myocardium often is exposed. (C) Reconstruction with straddling endoventricular patch annuloplasty. (D–F) Repair procedure with leaflet remnants reattached to pericardial patch.

 


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Fig 2. (A) Severe bacterial endocarditis of posterior leaflet. (B) Completion of aggressive broad excision of infected tissue. (C) A big gap in remaining tissue preventing recoaptation. (D) Valvuloplasty with pericardial patch as substitute for posterior leaflet.

 


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Fig 3. (A) Posterior leaflet detached from the annulus. (B) Posterior leaflet extension patch plasty providing an increase of more than 50% of the surface area.

 


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Fig 4. (A) Perforated anterior leaflet caused by acute endocarditis. (B) Patch as substitute for anterior leaflet.

 


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Fig 5. Papillary muscle head rupture resulting from acute myocardial ischemia.

 
To date, there have been few reports supporting the generalized use of valvuloplasty for mitral regurgitation (MR) caused by complex valvular disease. In general, these regurgitant valves have been replaced [35]. In 1987, we began to reconstruct the mitral valve with a patch of glutaraldehyde-treated autologous pericardium in conjunction with various innovative operative techniques [69]. This report describes our experience.


    Material and methods
 Top
 Footnotes
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 References
 
During an 11-year period ending in May 1998, 63 patients with severe MR caused by complex pathological processes had valve repair using glutaraldehyde-treated autologous pericardium as part of the reconstructive procedure (Table 1). There were 27 men and 36 women with an age range of 27 to 81 years, and they represented 12.5% of all patients undergoing reconstructive mitral valve procedures. Each patient underwent preoperative transthoracic or transesophageal echocardiography or both and coronary angiography with left heart catheterization. Left ventricular ejection fraction was greater than 0.40 in all patients. Before operation, mean regurgitant grade was 3.5, all 63 patients were in New York Heart Association functional class III or IV. Causes of the mitral valve disease included myxomatous degeneration in 38% (24 patients), rheumatic heart disease in 24% (15 patients), bacterial endocarditis in 22% (14 patients), ischemia in 11% (7 patients), and trauma in 5% (3 patients). Forty patients (63%) were in atrial fibrillation, and 5 of these had had previous strokes. Because of refractory congestive heart failure caused by active infective endocarditis, acute blunt cardiac trauma, or ischemic papillary muscle rupture, an emergency operation was required for 14 patients.


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Table 1. Techniques of Reconstruction

 
Surgical technique
After sternotomy and before aortic and bicaval cannulation, a 4- x 6-cm rectangular strip of autologous pericardium is harvested from the right atrial site and is cleaned of pleural tissues. The pericardial strip is fixed in a 0.62% glutaraldehyde-buffered solution for 30 minutes and then rinsed with saline solution in three separate bowls for an additional 30 minutes. The smooth surface of the pericardium is turned toward the atrium for valve repair. The surgical technique of patch application varies depending on the site of the lesion. All patients were operated on using normothermic cardiopulmonary bypass, hemodilution, topical cardiac cooling, and antegrade and then retrograde cold crystalloid St. Thomas’ II cardioplegia.

Pathological findings
Segmental analysis of the mitral valve apparatus showed calcification with degenerative changes involving at least a third of the posterior annulus presenting as a rigid curved bar that encircled the mitral orifice (see Fig 1A) in 23 patients. Calcification extending into the myocardial wall was found in 12. The paramedian chordae of the anterior leaflet were ruptured in 9 patients, and elongation of more than one main chorda was present in all instances. Rheumatic heart disease was observed in 9 patients with dense commissural and leaflet calcification; 6 of these 9 patients had mineralization to both the posterior annulus and the attached chordae. Large infected leaflets with vegetations (see Fig 2A) and multiple chordal ruptures were found in 14 patients and were due to bacterial endocarditis; 8 of these patients had perforated anterior leaflets (see Fig 4A) accompanied by posterior leaflet lesions and a damaged annulus. In 5 patients, an abscess involving the annulus (3 patients) or the valve tissue (2 patients) was found. One patient had abscess extension to the subvalvular apparatus, reaching the anterior papillary muscle. In another, the abscess had split the mitral-aortic junction, thereby detaching the anterior leaflet from the mitral annulus. There were purulent pockets from recidivistic endocarditis (as large as 3 cm) encapsulated within the endocardium along the posterior annulus in 2 patients. Commissural chordal rupture with prolapse of the anterior and posterior leaflets was noted in 3 patients. Three patients had traumatic leaflet and papillary muscle rupture. Rupture of the papillary muscle head resulting from acute ischemic heart disease (see Fig 5) was found in 2 patients and a dyskinetic/akinetic wall with apical displacement of the papillary muscle and leaflets, in 5.

Reconstructive techniques
Straddling endoventricular pericardial patch annuloplasty
In 12 patients, the mitral annulus was severely calcified with extension into the myocardium. Such massive calcifications often are encapsulated and covered by the endocardium. Decalcification was performed as an en bloc resection to prevent calcium fragmentation (see Fig 1A). Quadrangular resection of the posterior leaflet, often combined with complete detachment from commissure to commissure, was carried out. The two edges of fragile or fibrous tissue delimit the superior atrium and inferior ventricle (see Fig 1B). To reconstruct the annulus, a strip of pericardium was sutured to the ventricular inflow endocardium or to the fibrous skeleton of the heart and posterior left atrial wall with a continuous 5-0 or 6-0 polytetrafluoroethylene (PTFE) suture (Fig 1C). Defects created by the quadrangular leaflet resection were repaired by leaflet advancement. Leaflet reapproximation at the appropriate level and reattachment to the pericardial patch was carried out with a 6-0 or 7-0 PTFE suture (Fig 1D–1F).

Patch as substitute for posterior leaflet
This technique was applied to two groups, each consisting of 7 patients. Group 1 had bacterial endocarditis with a destructive process in which extensive tissue resection was required (see Fig 2A). Group 2 had severe degenerative prolapse involving more than two thirds of the posterior leaflet with mild to severe calcification that occasionally involved the posterior annulus. The patients in these two groups had pliable anterior leaflets. However, after removal of a substantial part of the posterior leaflet and part of the annulus (Fig 2B, see Fig 2C), neither the standard technique with sliding annuloplasty nor posterior leaflet folding plasty [10, 11] was able to achieve reconstruction of a competent valve because of a lack of sufficient tissue. In these instances, a pericardial patch was used to bridge the gap between the leaflet remnants and the annulus with a 6-0 or 7-0 PTFE continuous suture (Fig 2D).

Paracommissural extension patch plasty
A crescent-shaped pericardial patch was used in 8 patients to extend or to fill the commissural area when tissue shrinkage caused by rheumatic carditis, tissue destruction by perforation or colonization as a result of an infectious process, or anterior and posterior leaflet prolapse owing to ruptured commissural chordae were found. The patch was used to approximate the two leaflet remnants, which were then sutured together to form a neocommissural junction.

Posterior leaflet extension patch plasty
Increasing the posterior leaflet surface area by more than 50% (Fig 3B) was done in 13 patients who had heavily fibrotic areas in the leaflet with tissue shrinkage resulting from rheumatic carditis (8 patients) or posterior wall infarction (5 patients). The posterior leaflet was detached from the fibrous annulus from commissure to commissure (see Fig 3A). An ovoid patch with dimensions ranging from 2.0 to 4.5 cm in length and 1.5 to 2.5 cm in width was then sutured to the annulus and to the mobilized posterior leaflet with a 6-0 or 7-0 PTFE continuous suture (see Fig 3B). The width was calculated from the width of the anterior leaflet with a 1:3 ratio to avoid systolic anterior motion. The length was sized a few millimeters longer than the extent of the posterior leaflet incision.

Patch as substitute for anterior leaflet
Partial leaflet replacement was performed in 5 patients with anterior leaflet perforation resulting from active or healed bacterial endocarditis (see Fig 4A). A circular pericardial patch was used to repair the defect after excision of the edge of the perforation (Fig 4B).

Reimplantation of papillary muscles
Papillary muscles were ruptured in 5 patients (see Fig 5), 2 of whom had acute ischemia and 3, cardiac trauma. Pericardial pledgeted 7-0 PTFE sutures were used to reattach the ruptured muscles to the trabeculae.

Chordal replacement
Sufficient chords for chordal transfer were not available in 5 patients after aggressive tissue debridement. A strip of treated pericardium about 4 mm wide and 4.5 cm long was tailored for chordal replacement. One arm of the strip was attached to the appropriate fibrous portion of the papillary muscle head with two to three 7-0 PTFE mattress sutures. The lengths were determined before the other arm was sewn to the prolapsed free edge usually on its ventricular surface (Fig 6) by comparing it with the opposing normal leaflet or the commissural reference point.



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Fig 6. Chordal replacement with autologous pericardium anchored to trabecula using 7-0 polytetrafluoroethylene sutures.

 
Posterior annulus remodeling
Using an appropriate Carpentier annuloplasty sizer and a strip (4 to 5 mm x 50 to 60 mm) of pericardium, the shape of the posterior mitral annulus was modeled [12]. In 7 patients with active infective endocarditis, in an effort to prevent recurrent endocarditis and avoid as much prosthetic material as possible, the pericardial strip was anchored to the posterior leaflet annulus from trigone to trigone, including the anatomical commissures, with interrupted mattress sutures of 3-0 Ticron.

Associated procedures
Other standard Carpentier repair techniques [10] were also used. All but 8 patients had prosthetic annuloplasty. Nine patients had coronary artery bypass grafting, and 5 patients underwent De Vega annuloplasty for severe tricuspid regurgitation.


    Results
 Top
 Footnotes
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 References
 
Intraoperative transesophageal echocardiography after repair showed satisfactory results initially with no or trivial MR in 61 patients and grade I–II MR in 2 patients. There were no operative deaths or perioperative complications. Inotropic support for postoperative low cardiac output was required in 3 patients. Seven patients were treated for renal dysfunction. Pneumonia in 3 patients necessitated prolonged respiratory care. Gastric hemorrhage occurred in 1 patient. Four patients required pacemaker implantation early after repair. One 72-year-old patient with Barlow’s disease required re-repair with a small resection of the anterior leaflet and remnant recoaptation because of spontaneous chordal rupture 3 weeks after the initial successful operation. Two patients with rheumatic heart disease and grade I–II MR postoperatively had rapid progression of MR necessitating valve replacement within 1 year. The aortic valve was replaced in a young patient with Marfan’s syndrome 3 years after mitral valve repair with a patch.

Echocardiographic studies were performed in all patients intraoperatively, before hospital discharge, 3 months postoperatively, 6 months postoperatively, and then every 12 months after operation. At 1 year and 5 years, follow-up demonstrated 58 patients with no or only trivial MR and 3 patients with grade I–II MR. The left ventricular end-diastolic diameter decreased significantly after operation (from 59.6 ± 6.5 mm to 51.2 ± 5.5 mm; p < 0.001), as did the end-systolic diameter (from 38.8 ± 4.6 mm to 35.9 ± 4.3 mm; p < 0.001). The reduction in left atrial diameter was substantial (from 54.9 ± 6.8 mm to 44.4 ± 6.6 mm; p < 0.001). Neither systolic anterior motion of the mitral valve nor any left ventricular outflow gradient was observed (mean velocity in left ventricular outflow tract, 0.83 ± 0.63 M/s).

No patient experienced thromboembolism or recurrent endocarditis during the postoperative course. To date, there have been no major hemorrhagic complications. Fifty-four patients are in New York Heart Association functional class I and 6, in class I–II. One patient died of recurrent myocardial infarction 6 years after successful valve repair. Twelve patients who previously experienced atrial fibrillation are now in sinus rhythm, and 28 patients remain in atrial fibrillation. Eighteen patients are on a permanent regimen of anticoagulation.

Thirty-three patients were followed for more than 5 years. In the follow-up of 4.1 to 132.3 months (mean follow-up, 61.1 ± 39.6 months), the incidence of reoperation was 4.8% (3 patients). Kaplan-Meier univariate analysis was used to calculate the freedom from death, thromboembolism, reoperation, myocardial infarction, endocarditis, and anticoagulation-related hemorrhage after mitral valvuloplasty. Event-free survival at 5 years was 90.5% (Fig 7).



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Fig 7. Event-free survival (freedom from death, thromboembolism, reoperation, myocardial infarction, endocarditis, and anticoagulation-related hemorrhage) after mitral valvuloplasty. The upper graph lines represent event-free survival at the end of follow-up (freedom from death, thromboembolism, reoperation, myocardial infarction, endocarditis, and anticoagulation-related hemorrhage) after mitral valvuloplasty. The lower graph line indicates the patients at risk.

 

    Comment
 Top
 Footnotes
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 References
 
For mitral valve repair, there are a variety of surgical maneuvers tailored to the different lesions in a given valve. However, repair of severe MR caused by complex valve pathological processes such as extensive calcification of the annulus, destructive infective endocarditis, abscess of the mitral valve apparatus, large perforations, heavy myxomatous degeneration, and rheumatic carditis is often severely limited by the remaining amount of unaffected tissue after extensive tissue debridement (see Figs 1B, 2C, 4A) [7, 8, 13, 14]. Valvuloplasty by the application of a patch is thus unconditionally required in such situations; otherwise these valves would be replaced.

The use of pericardium has been attractive. Its ready availability, its ease of handling, and its pliability make it an obvious choice when a defect must be corrected. Use of fresh autologous pericardium has been discouraged because of problems encountered after implantation, namely, progressive contracture, thickening fibrosis, loss of pliability, early degeneration, and endocarditis [6, 15]. The technique of fixation of autologous pericardium is extremely important in determining tissue durability and resistance to calcific degeneration after long-term implantation. In 1989, Chauvaud and associates [7] reported successful valvuloplasty in 35 patients using autologous pericardium treated with a 15-minute immersion in glutaraldehyde. Other groups [1618] have subsequently demonstrated that short-term glutaraldehyde treatment of autologous pericardium should be not less than 15 minutes to preserve basic tissue stability and strength and not more than 60 minutes to avoid excessive calcification. Because glutaraldehyde-fixed autologous pericardium is nonantigenic, it is preferred over the standard bovine pericardium, and this is corroborated by excellent results [8]. In addition, xenograft tissue carries the small but proved risk of transmission of viral disease, including human immunodeficiency virus [19].

Removal of heavy annular calcification is a potential lethal risk factor in mitral valve operations because of the possibility of atrioventricular rupture [13]. In its severe form, the annular calcification is a rigid curved bar of calcium that encircles the mitral orifice (see Fig 1A), and calcific spurs can project into the adjacent left ventricular myocardium. Its removal after dissection leaves the atrium, the ventricle, and the valve separated, thus necessitating atrioventricular reconstruction (see Fig 1B). The application of glutaraldehyde-treated autologous pericardium as a straddling endoventricular pericardial patch annuloplasty (see Fig 1C–F) is a reliable technique to protect the left ventricle from rupture after en bloc decalcification [13]. The patch valvuloplasty used in our study remained stable without evidence of early calcification or fatigue, thereby demonstrating the feasibility of repair in severe cases of calcification.

There are some limits to the degree of mitral annulus or leaflet calcification amenable to mitral repair techniques. Five patients were excluded from our study because the contraindication to repair was heavy calcification involving more than a third of the circumference of the annulus or calcification associated with poor mobility of both leaflets. In patients with isolated rheumatic mitral valve disease, the durability of mitral valve reconstruction is not as good as in patients without rheumatic disease. Nevertheless, there is evidence that patients with rheumatic disease undergoing repair have improved late survival independent of their preoperative characteristics and therefore should undergo repair when technically feasible to maximize survival and reduce morbidity, even though there is a risk of reoperation [8, 13, 14, 20]. When good annulus and leaflet motion remain intact in calcified mitral valves [8, 13, 14], the ability to perform paracommissural extension patch plasty, to extend the posterior leaflet or to carry out chordal replacement in this subgroup of patients might depend largely on the availability of a patch that can be used immediately.

In general, mitral valve repair has been considered a contraindication during the acute phase of endocarditis. The rate of infection after prosthetic valve replacement is as high as 8% to 20%, and reinfections involve the same organism cultured at the initial valve replacement [21]. Valvuloplasty with a pericardial patch (Figs 2D, 4B) enables efficacious valve repair after aggressive broad excision of infected tissue (see Fig 2B). The aims of surgical intervention—to remove mobile vegetations that are potential sources of systemic emboli, to obliterate abscess cavities that could create a focus of resistance to antibiotics, and to close any fistulas between the two ventricles—have been fulfilled in our patients. In addition, valvular function was restored, thus ensuring an optimal hemodynamic outcome. Even in the acute phase of mitral valve endocarditis, an emergent repair procedure does not predispose our patients to a significantly higher risk of late recurrence of endocarditis.

When MR is due to extensive ischemic necrosis of the papillary muscle and the adjacent ventricular wall, surgical repair is associated with high morbidity and mortality. Although valve repair is preferable, most surgeons replace the valve [5, 12, 22, 23]. One reason for the unpredictable outcome after repair is the asymmetric geometry of the mitral leaflets secondary to papillary muscle dysfunction and infarction of the adjacent myocardium or mitral annulus dilatation from prior infarction with resultant left ventricular enlargement. The infarcted papillary muscle does not contract and continues to shorten as the necrotic muscle is replaced by fibrous tissue. The apical pull of papillary muscles at end-systole is unbalanced. These deformations tend to produce restriction of leaflet motion leading to less leaflet coaptation. The papillary muscle discoordination with mitral annulus dilatation distorts leaflet coaptation sufficiently to produce severe MR [2325]. Although several previous studies have focused on applying an annuloplasty ring to restore valvular competence, this procedure is often not efficacious and fails to eliminate the MR in every patient [5, 9]. Our disappointing results in an earlier series of repair corroborates the results of Komeda and colleagues [26], who showed that the asymmetric displacement of the papillary muscles after infarction could not be normalized with an annuloplasty ring alone.

Repair of valves with this asymmetric geometry also requires readjustment of the leaflet excursion or the papillary muscle–annulus relationship. With the papillary muscle and chordae length unaltered, the coaptation gap or incomplete mitral leaflet coaptation caused by the asymmetric geometry can be corrected by increasing the posterior leaflet surface area using extension plasty with autologous pericardium (see Fig 3B). The leaflet edges are brought closer together, thereby allowing coaptation to occur more readily. In addition to the use of an annuloplasty ring to reduce the dilatation of the mitral valve, this new strategy successfully eliminated severe ischemic regurgitation in our patients with restrictive leaflet motion. When the results of leaflet extension plasty are good, this is likely due to the readjustment of the papillary muscle–annulus relationship in a geometrically deformed mitral valve after acute or chronic myocardial ischemia.

To date, the use of pericardial patches in valvuloplasty seems to delay the process of valve shrinkage, probably because it provides better mobilization of the leaflet tissue, a larger surface of coaptation, and less turbulence. Our clinical results showing continued valvular competence indicate that glutaraldehyde-pretreated autologous pericardium is the material of choice for complex mitral valvuloplasty. It provides durable and predictable repair of valves that might otherwise need to be replaced because of complex mitral valve pathological processes. The application of autologous tissue seems to produce long-term success without important late calcification. Further extensive long-term evaluation of this method is warranted, as there is yet no ideal mitral valve substitute. Valvuloplasty performed by surgeons proficient with the technique can offer outcome advantages suggesting that early operation is feasible before ventricular dysfunction occurs and allows for new strategies in these patients [2]. The ultimate goal, ie, restoration of a neo-valve with "normal" function and avoidance of the use of foreign materials, is appealing, and we believe that glutaraldehyde-treated autologous pericardium could accomplish this goal.


    Acknowledgments
 Top
 Footnotes
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 References
 
We are deeply grateful to Dr Bauer E. Sumpio for his help in the preparation of this manuscript.


    Footnotes
 Top
 Footnotes
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 References
 
This article has been selected for the open discussion forum on the STS Web site: http://www.sts.org/section/atsdiscussion/


    References
 Top
 Footnotes
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 References
 

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