Scandinavian Journal of Thoracic and Cardiovascular Surgery

ISSN: 0036-5580 (Print) (Online) Journal homepage: http://www.tandfonline.com/loi/icdv19

Our Experience with the Carpentier–Edwards Bioprosthesis Jörgen Swedberg, Sture Larsson, Donald Roberts & Göran Südow To cite this article: Jörgen Swedberg, Sture Larsson, Donald Roberts & Göran Südow (1979) Our Experience with the Carpentier–Edwards Bioprosthesis, Scandinavian Journal of Thoracic and Cardiovascular Surgery, 13:1, 33-35, DOI: 10.3109/14017437909101783 To link to this article: http://dx.doi.org/10.3109/14017437909101783

Published online: 12 Jul 2009.

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Date: 26 March 2016, At: 00:15

Scand J Thor Cardiovasc Surg 13: 33-35, 1979

OUR EXPERIENCE WITH THE CARPENTIER-EDWARDS BIOPROSTHESIS Jorgen Swedberg, Sture Larsson, Donald Roberts and Goran Siidow From the Depurtment of Thorucic Surgery, Sahlgrrnsku Sjirkhuset, Univrrsitv of Gijtehorg. Giitrhorg, Sisedrn

(Submitted for publication January 26, 1978)

Sixty Carpentier-Edwards porcine valve bioprostheses stabilized with glutaraldehyde were implanted in 55 patients with acquired and congenital heart disease. The follow-up period ranged between I and 12 months. There were 3 hospital deaths ( 5 % ) and 2 late deaths (4%) in 24 mitral, 24 aortic, 5 mitral-aortic, 1 tricuspid and 1 pulmonary valve replacements. All patients were anticoagulated from the second postoperative day onwards for a period of 3 months after which those with sinus rhythm had their anticoagulants withdrawn. Paravalvular leakage led to re-operation in 3 cases (4%). No valve failure due to cusp rupture was encountered and no thromboembolic complications have occurred. Thirtythree patients were studied postoperatively by noninvasive methods and the results are presented.

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Absrruct.

During the past twelve years porcine aortic valves preserved formerly in formalin and later in glutaraldehyde have been in use. The CarpentierEdwards and the Hancock glutaraldehyde preserved porcine aortic valves are examples of these devices. Earlier models were placed on rigid frames, but later models are mounted on completely flexible or partially flexible frames to distribute the stress evenly. These valves are characterized by centraf flow. The preliminary experience has been encouraging with the valve in both the mitral and aortic position. Smaller sizes of these valves, however, are too obstructive and this may exclude their use. A number of comparative features are now available for the types of valves used for prosthetic replacement (Roberts, 1976). Obstruction to flow is met with the caged ball, caged disc, tilting disc and the glutaraldehyde preserved xenografts. Incompetence is met with homograft valves. Thromboembolic phenomenon is seen in patients with all valves but are very rare with tissue valves. Prosthetic destruction o r degeneration occurs with the caged ball, caged disc and homograft valves. The 3 - 792') 13

xenograft is not thrombotic o r haemolytic; no one knows whether it will degenerate with the passage of time. Preliminary reports and laboratory studies report satisfxtory function for at least seven to eight years (Carpentier. 1969 and 1974; Gallucci, 1976; Albert, 1976; Wright, 1975). The advantages of these mounted heterogrdfts are: (1) availability in all sizes; (2) the technique of implantation is the same as for prosthetic valves; (3) they should be non-thrombogenic after the cloth stents are endothelialized; (4) the central flow; ( 5 ) the avoidance of anticoagulation treatment. The Carpentier-Edwards bioprosthesis (Fig. I ) consists of porcine aortic valves preserved in 0.6 % glutaraldehyde solution and mounted on a cloth covered flexible frame of an alloy, Elgiloy. containing cobolt and nickel. There are different models for aortic and mitral valve replacements (Carpentier et a!., 1969 and 1974; Albert et al., 1977; Zuhdi et al., 1974). CLINICAL EXPERIENCE We began using these prostheses in April 1976, at first only in the mitral position, but now they are used for all types of valve replacements. Twenty-

Fix. I . The Carpentier-Edwards bioprosthesis

34

J . Swedberg

i>t u l .

Table I. A g e , sex urrd liospitcil mortulity in 53 putients biitli the C(irprntiL,r-Ed~ciri,.dsprosthesis in the uor!ic trnd rnitral positions

Sex

Range

Mitral 24

6

Aortic 24

0 10 d 18 0 6

3241 I447 2245 29-66 5443

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Double 5

6 6

14

3 2

Mean

Hospital deaths

58.2

0 I L . V . rupture 1 Cardiac failure. ai-rhythmia 0 I P Cardiac failure, could not come off the machine

51.6

51.6 52.8 58

four patients had aortic and 24 mitral replacements, 5 had double valve replacements (Table I). In addition, a 7-year-old girl with congenital tricuspid insufficiency had this valve replaced. A 45-year-old man with enormous dilatation of the pulmonary artery and gross pulmonary valve insufficiency had the pulmonary valve replaced. The age of the patients ranged from 7 to 67 years. The 3 hospital and 2 late deaths could not be attributed to the bioprosthesis. Extracorporeal circulation was achieved by using the Polystan oxygenator and the Sarns console. We compared three different methods for what is called myocardial protection: ( 1 ) general hypothermia at 28°C with intermittent cross-clamping of the aorta for periods of about 20 min; ( 2 ) topical hypothermia with cross-clamping of the aorta for 57-100 min; ( 3 ) general hypothermia at 28°C with bilateral coronary perfusion. We have not been able to find any differences in myocardial performance with the three methods used. W e used Ethibond as suture material with interrupted sutures in all aortic replacements and in the

majority of mitral prostheses, and a continuous suture only in a few. The sutures were reinforced with teflon pledgets or small pieces of silicon tubing. All patients were anticoagulated with sodium warfarin and acetyl salicylic acid on the second postoperative day onwards for a period of 3 months, after which those without atrial fibrillation had their sodium warfarin withdrawn. In no cases have we observed thrombo-embolic complications. The prosthetic function in the postoperative follow-up was assessed in 35 patients by noninvasive methods, namely: phonocardiography, echocardiography, pressure wave analysis and doppler flow studies. These methods produced very detailed and reliable information and have replaced postoperative catheterization and angiography (Table 11). N o insufficiency could be detected in 24 patients. Eight had slight regurgitation without cardiac performance being affected. Three patients-? mitral and one aortic-showed gross regurgitation due (MI

iAI postop

postop

~

No regurgitation. Good myocard. performance Little regurgitation. Good myocard. performance Large regurgitation. Poor myocard. performance (all re-operated)

Aortic

Mitral

Double

14

9

1

2

5

I (mitral) 2 Pre- and postoperative functional classe\ ( N Y H A ) in (A) 22 aortic patient\ and (M) 22 mitral patients, who underwent single valve replacements with a Carpentier-Edwards prosthesis.

Fig

I

7

i

The Carpentier-Ecl~)lii.cl~~ biopsosthesis

Table 111. Employrnrrit ,statiis of50 sirr\’i\lor.s ufter prosthesis during the ,first yemr ufier surgery

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Full activity Part time work Full sick pension

vliI\,i>

rrplplcicemerit with the CNrpentier-Ecllr’rrvds hio-

Aortic

Mitrdl

Double

Tricuspid

Pulmonary

Total

10

3 13 6

0

I

I

15 23 12

8 4

2 2

to paravalvular leakage. The mitrals were resutured. The aortic bioprosthesis developed signs of gross paravalvular leakage five weeks after the diagnosis of acute endocarditis, and prosthetic endocarditis could not be ruled out. The long-term survival of a bioprosthesis in the presence of an endocarditis has not yet been established and therefore a mechanical prosthesis (Lillehei-Kaster) was used t o replace the bioprosthesis. There were 5 deaths, 3 hospital or 5 % and 2 late o r 4% in this total of 55 patients. In none of the cases was death due to failure of the bioprosthesis. N o case of cusp rupture was seen at post-mortem. The postoperative functional changes was assessed according to the New York Heart Associations (N.Y.H.A.) Classification (Fig. 2). More aortic patients showed greater and swifter improvement in a shorter period than mitral patients. A pre-operative heart size of less than 750 ml/m’ body surface seemed to be the critical volume for postoperative functional recovery during the first year. Such hearts showed gratifying functional improvement even though the mitrals improved much slower than the aortics (Fig. 2). Hearts above the size of 750 ml/m’ showed a striking delay or impairment of functional recovery. In spite of the palliation, this poor functional recovery is a disappointment in chronically ill patients. The employment o r occupational status in the 50 survivors are as follows (Table I l l ) : Fifteen have returned to full activity, the majority being aortics; 23 require partial sick benefits, the majority being mitrals. Four of them have reached retirement age; 12 are unable to work, 3 of whom have reached retirement age. CONCLUSION The summary of our experience with the Carpentier-Edwards bioprosthesis is as follows: ( I ) 60 such prostheses were implanted in 55 patients with a hospital mortality of 5 % and a late mortality of 4 % ;

35

( 2 ) the follow-up time ranged from 1 to 12 months; ( 3 ) anticoagulant therapy was safely stopped 3 months after surgery and no thrombo-embolic complications have occurred; (4) three cases were re-operated on due to paravalvular leakage; (5) no failure due to cusp rupture has been detected. REFERENCES Albert, H. M., Bryant, L. R. & Schechter, F. G. 1977. Seven year experience with mounted porcine valves. Ann Surg 185, 717-723. Carpentier, A., Lemaigre, G . , Robert, L., Carpentier, S. & Dubost, Ch. 1969. Biological factors affecting longterm results of valvular heterografts. J Thoruc C r r r d i o ~ ~ ~Surg s c 58,467. Carpentier, A . , Deloche, A . , Relland, J., Fdbiani, J. N . , Forman. J . , Camilleri. J . P., Soyer. R.. Dubost, Ch. & Malm, J . R. 1974. Six-year follow-up of gluteraldehyde-preserved heterogrdfts. J Thorrrc~Ctrrdiot’usc. Sirrg 68. 771-782. Gallucci, V . , Cevese, P. G . , Morea, M. et al.: Hancock bioprosthesis: Analysis of long-term results ( 6 years). 1976. Circ~rrltrrion54. Supplement 11. 149. Griepp, R., Salomon, N . , Stinson, E. & Shumway, N . 1976. Mitrdl valve replacement: Long-term evaluation of prosthesis related mortality and morbidity. Circulotion 54, Supplement 11, 148. Roberts, W. C. 1976. Choosing a substitute valve: type, size, surgeon. A m J Curdiol38, 633-644. Starr, A. & Edwards, M. L. 1961. Mitral replacement: The shielded ball valve prosthesis. J Thoruc Curdiovusc Surg 42, 673. Wright. J . T. M . 1975. Flow dynamics in prosthetic valves-an assessment of hydrodynamic function. Procccdings o j ihi> Intrrtiritiot~~rl Symposirrtn on the Mitrul V t r / v e . Paris, May. Zuhdi, N., Hawley, W., Voehl, V., Hancock, W. J., Carey, J. & Greer, A. 1974. Porcine aortic valves as replacements for human heart valves. Ann Thoruc Surg 17, 4 7 9 4 9 1 .

ADDENDUM Since this paper was sent for publication we have put in altogether 187 bioprostheses in 169 patients and with the same good results. k m d J I l l o r C i i i d i i w i i . > i .Suw /.

Our experience with the Carpentier-Edwards bioprosthesis.

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