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J Thorac Cardiovasc Surg 1999;117:141-147
© 1999 Mosby, Inc.
SURGERY FOR CONGENITAL HEART DISEASE |
From the Sections of Thoracic and Cardiovascular Surgery,a Cardiology,b and Pediatric Cardiology,c University of Oklahoma Health Sciences Center, Oklahoma City, Okla.
Read at the Seventy-eighth Annual Meeting of The American Association for Thoracic Surgery, Boston, Mass, May 3-6, 1998.
Received for publication May 8, 1998. Revisions requested June 5, 1998. Revisions received Sept 22, 1998. Accepted for publication Sept 28, 1998. Address for reprints: Christopher J. Knott-Craig, MD, Section of Thoracic and Cardiovascular Surgery, University of Oklahoma Health Sciences Center, Post Office Box 26901, Oklahoma City, OK 73190.
| Abstract |
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| Introduction |
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Although the results of cryopreserved homograft valves for reconstruction of the right ventricular outflow tract in complex congenital heart diseases has been reported by several previous authors,
5-13 reports on medium-term follow-up are still uncommon.
14,15 We reviewed our experience since 1985 with 331 patients, including Ross operations, in whom cryopreserved homografts were used in the "pulmonary" position to examine the risk factors associated with homograft failure over the mid-term follow-up period.
| Methods |
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Patient characteristics
The median age at operation of the 237 male patients and 94 female patients was 14 years (range, 2 days62 years). The homografts were used as part of the following operations: Ross operation (n = 259; 78%), tetralogy of Fallot or pulmonary atresia with ventricular septal defect (n = 41; 13%), truncus arteriosus (n = 14; 4%), Rastelli-type operation (n = 11; 3%), and others (n = 6; 2%). One hundred eighty patients (54%; 180 of 331 patients) had undergone previous cardiac operations, 46 (14%) of which were on the pulmonary outflow tract. Twenty-one patients had a previous right ventricular outflow tract (RVOT) reconstruction with a homograft, and 5 patients had a previous aortic valve replacement with a homograft.
Homograft characteristics
Twenty-seven aortic homografts and 304 pulmonary homografts were used. The median age of the homograft donors was 19 years (range, 5 months58 years). The homografts varied in size from 10 to 30 mm in diameter (mean, 22.4 ± 4.1 mm). The mean time period between harvesting and implantation of the homografts was 7.7 ± 8.4 months (duration of cryopreservation).
Patient follow-up
The medical records of the 331 patients included in this study were reviewed to obtain detailed information on the operation, previous intervention, subsequent need for operative treatment, and physical status. Homograft status was evaluated by 2-dimensional, color flow, and continuous wave Doppler echocardiography. The pressure gradient across the RVOT was measured by peak instantaneous Doppler velocity with pulse and continuous wave Doppler techniques. Peak flow velocities were obtained from the Doppler tracings and converted to peak instantaneous gradients by a simplified Bernoulli test. Homograft regurgitation was graded subjectively as 0 to 4, with 3+ or greater representing significant regurgitation. Follow-up ranged from 1 month to 11.2 years (median follow-up, 3.8 years).
Definitions of end points
Homograft failure was defined as all reoperations involving explantation of the homograft and all valve-related deaths.
12,15 Moderate (3+) pulmonary insufficiency and transvalvular gradient greater than 40 mm Hg were defined as homograft dysfunction.
12,16 The distribution of outcomes with diagnosis groups is shown in Table I. There were relatively few patients at risk of conduit failure or dysfunction beyond 8 years of follow-up; hence most data are reported as 8-year follow-up.
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2 or Fisher's exact methods were used to test differences between proportions. Actuarial estimates of freedom from postoperative events were accomplished with Kaplan-Meier methods, and P values for differences between distributions were obtained by log-rank testing. Event-free rates are presented with ± 1 SE of the estimate. Potential risk factors evaluated in multivariable analysis of conduit failure or dysfunction included age, weight, sex, date of operation, diagnosis, previous cardiac operations, previous homograft, type of homograft (either aortic or pulmonary), size of homograft, duration of cryopreservation, and age of homograft donor. The analyses were performed with Cox proportional hazards regression. A forward stepwise selection method was used to add variables to the model, requiring significance at P < .10 for entry and P < .05 for retention in the model. Early death was defined as hospital death or death within 30 days after operation. | Results |
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Thirty-nine patients had evidence of homograft dysfunction; of those, 29 have had the homografts replaced. One additional patient had the homograft replaced after an inadvertent injury during an unrelated cardiac operation. Forty patients (12%) therefore had either homograft dysfunction or conduit failure.
Homograft failure
Homograft failure occurred in 30 patients (9%; 30 of 331 patients). These include the 2 valve-related deaths. The indications for explanting the homografts were conduit stenosis in 23 patients, homograft insufficiency associated with distal pulmonary artery stenosis in 3 patients, homograft hood aneurysms in 2 patients, technical error in 1 patient, and injury of the homograft during repair of an autograft in 1 patient. Kaplan-Meier freedom from homograft failure was 90% ± 2% at 5 years and 82% ± 4% at 8 years (Fig 1). This was 89% ± 4% for patients having a Ross operation at 8 years versus 62% ± 9% for all other patients (P = .0001). At 8 years, freedom from failure was 86% ± 4% for pulmonary homografts versus 61% ± 11% for aortic homografts (P = .003).
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| Discussion |
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As the Ross operation (pulmonary autograft replacement of the aortic valve) has gained popularity, so too has the use of the pulmonary homograft to reconstruct the RVOT in this patient population.
3,4 In fact, most of our patients fall into this category. Patients having a Ross operation generally have normal pulmonary vascular anatomy and resistance, and this may account for the better late results with pulmonary homografts in these patients. In contrast, many patients with other forms of congenital heart disease have distal pulmonary artery branch stenoses or high pulmonary vascular resistance, both of which may affect the durability of the homografts.
7,27,28 In fact, younger recipient age,
8,12,13 use of the aortic homograft,
7,12,15 small homograft valve size,
13 long aortic crossclamp time at operation,
15 pulmonary hypertension,
27 and distal pulmonary artery disease
7,28 have all previously been identified as risk factors associated with medium-term failure of cryopreserved homografts in the RVOT. Young age at operation seems to be a common risk factor of the homograft failure,
8,12,13 because this closely relates to the size of the homograft implanted and therefore to the age of the homograft donor. In addition, infants generally triple their size within 18 months, thus outgrowing their homograft more quickly than older children. This was confirmed in our univariate analysis of homograft dysfunction by age (Fig. 5
). However, in our multivariable analysis young patient age (<3 years) was not associated with an increased risk of failure.
It is interesting to speculate that younger donor age is somehow related to increased immunogenicity of the homograft and that this may have negatively affected the late function of the homograft; the strong association of young donor age in our multivariable analysis adds support to this theory. Furthermore, severe homograft valved conduit stenosis developed within the first postoperative year in a few patients who underwent the Ross operation.
29,30 The stenosis was usually located just above the commissures in the proximal portion of the homograft conduit. One additional patient experienced the development of rapid homograft deterioration within 4 months of reoperation for such an obstruction. These findings lend some credence to a possible immune-mediated response,
17 although this speculation remains unproved.
31-33 It is possible that some form of perioperative immunosuppression may be beneficial in these high-risk patients.
17,30
Although aortic homografts have been used to reconstruct the pulmonary outflow tract for many years,
2,5,20 the aortic valves have been considered to be susceptible to higher rates of calcification in the pulmonary position than the pulmonary homograft valves because of their higher elastin and intrinsic calcium content.
34 The Mayo Clinic group
12 recently reported that, in the pulmonary position, the pulmonary homograft was more durable than the aortic homograft valves with less calcification and obstruction, especially among children 4 years of age or younger. Our study, in which the aortic homograft was shown to be an independent risk factor for homograft dysfunction, confirms their findings.
Technical factors such as hood extension of the proximal suture line, anatomic versus nonanatomic placement of the conduit, and compression of the conduit behind the sternum may all be important determinants of homograft longevity.
12 These were not specifically analyzed in our study because of the limited number of such procedures. We did not identify individual cardiac diagnoses or operative procedures within the non-Ross operation group of patients as significant risk factors. Rather, all the congenital cardiac disease subgroups were collectively associated with increased risk compared with the patients having a Ross operation.
Later year of operation was associated with increased risk both of homograft failure and homograft dysfunction. We are unable to explain this finding within the context of our present study but are further analyzing patient factors and preservation and biocompatibility factors in an attempt to resolve this dilemma.
In summary, for RVOT reconstruction, non-Ross procedure, cryopreserved aortic homograft valves, homograft valves from younger donors, and later operation were significant risk factors for homograft failure. The cryopreserved pulmonary homograft valve appears to be the conduit of choice for RVOT reconstruction.
| Appendix: Discussion |
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However, when we reanalyzed our data and included all reasons for conduit replacement such as false aneurysms of the anastomotic sites, nearly all of which were associated with pulmonary homografts in patients with right ventricular hypertension, we found that there really was no difference in late failure at least through 4 years. So, the failure rate depends a little bit on one's definition of homograft failure.
You presented an interesting new set of data that showed that the incidence of homograft failure was less in patients after the Ross procedure as compared with other operations for congenital cardiac anomalies. This may explain, in part, the difference between the behavior of pulmonary homografts in our series compared with yours. Can you discuss the reasons why there is a difference in homograft failure between Ross and non-Ross operations?
There was no mention of balloon dilatation or stenting for homograft stenosis. This does seem to be a problem in some series. Was this done in any patients in your series and were such patients included as having homograft dysfunction?
The pulmonary autograft procedure remains controversial. In some excellent institutions, few if any such operations are currently performed especially in adults, because of the additional complexity of the procedure, because of the fact that 2 cardiac valves are put at risk instead of 1, and, until recently with reports such as yours, because of the lack of data regarding late results of cryopreserved homografts in the pulmonary position. In other excellent institutions, the Ross procedure is a treatment of choice.
In view of recent reports of up to 90% or more of patients being free of reoperation for homograft failure 10 years after isolated homograft replacement of the aortic valve (especially patients treated with the current trend toward intraluminal cylinder or root replacement rather than use of a scalloped homograft), together with the 16% incidence of incompetent right ventriclepulmonary artery homografts, homograft dysfunction, or homograft replacement at 8 years after the Ross procedure in your series, what are your current thoughts on the relative role of the Ross procedure in the treatment of aortic valve disease?
Dr Knott-Craig. With regard to the first question, that the failure rate and the structural deterioration rate is lower in patients who have Ross operations versus the other pathologies relates mainly to the fact that patients having isolated aortic valve replacement have normal distal pulmonary artery vasculature both in terms of pulmonary hypertension and in distal embolization problems.
In terms of balloon dilatation of the pulmonary homografts, this is not a favored technique in our institution. We have a very low threshold to replace homografts rather than have the cardiologists address them either with stents or balloon dilatations.
The question about the Ross operation is a little beyond the scope of my presentation. However, generally speaking, when any new operation is adopted by a wide variety of surgeons with varying expertise, the indications become diluted and complications can be anticipated, resulting in reoperations on the aortic valve or pulmonary valve. However, the alternatives available in young children and infants remain limited, and this is the area where the Ross operation has its greatest aptitude.
Dr Charles A. Yankah (Berlin, Germany). The group in Berlin has done over 300 homograft implantations in the RVOTs. Since 1986 we have known that the pulmonary homograft is the valve of choice and that it is a better alternative. The question is whether a viable homograft will be suitable for children, especially, because our immunologic problem with homovital cryopreserved homografts, which were used mainly in infants and in children, subsequently yielded no satisfactory results. The pathologic condition of the homograft explants was either at the valvular level with degenerative stenosis or at the supravalvular level. Did you observe such pathologic changes with regard to multilevel stenosis, which we observed especially in our children? With regard to your experience, would you derive any suggestion for preferring a nonviable homograft in infants and children, rather than homovital or viable homografts?
Dr Knott-Craig. If one tries to define why later year of operation was a risk factor for dysfunction or failure and why younger donor age was a risk factor for both failure and dysfunction, there are limited alternative explanations. We think that immunogenicity is important and is more important the younger the patient. We tried to define this better in our analysis by looking at the duration of cryopreservation from harvesting to the implantation of the homograft. Although this seemed important, it never stood up in the multivariate analysis as an independent risk factor for failure. We have also seen early homograft failure particularly in young children. Currently, if this should occur within 1 year of the operation, we put the patient on high-dose ibuprofen or steroids for the first 3 months after the operation. So yes, I think viability of the cells is an issue in children, but we have not yet defined how to deal with it.
Dr Lawrence H. Cohn (Boston, Mass). I have one very short question. This is a fantastic series. For those of us who do this in young adults, can you give us any estimate of the freedom of homograft dysfunction at 8 years in patients who are 18 years or older when you do this operation?
Dr Knott-Craig. In the age group 18 to 40 years, the freedom from homograft dysfunction is about 82% at 8 years, not statistically different from the 0- to 18-year age group.
| Acknowledgments |
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| References |
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