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a Department of Surgery, Yokohama City University, Fukuura 3-9, Kanazawa-ku, Yokohama 236-0004, Japan
b Department of Cardiovascular Surgery, Fukuoka Children Hospital, Japan
c Department of Cardiovascular Surgery, Kyushu University, Japan
Received 26 August 2007; received in revised form 31 March 2008; accepted 9 April 2008.
* Corresponding author. Tel.: +81 45 787 2644; fax: +81 45 786 0226. (Email: mmasuda{at}yokohama-cu.ac.jp).
| Abstract |
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Key Words: Mechanical prosthetic valve Children Aortic valve replacement Ross procedure Bileaflet mechanical prosthetic valve Aortic annular enlargement
| 1. Introduction |
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There are four types of substitutes available for the aortic position at the moment. Porcine bioprosthesis and bovine pericardial bioprosthesis are considered to be good substitutes for elderly people because of their excellent anti-thrombogenesity, while they are considered unsuitable for children because of their poor durability in young patients [1–4]. Allograft has been implanted especially in small children because of its variety of size, excellent anti-thrombogenesity and good flexibility. However, allograft also has the disadvantage of limited durability due to early calcification in young recipients and limited availability in the market [3,5]. Mechanical valve requires lifelong cumbersome anticoagulation, while it shows an excellent long-term performance with relatively low incidence of complication in children [4,6,7].
There has been increasing enthusiasm for pulmonary autograft (Ross procedure) for aortic valve replacement in children and adolescents. It shows good hemodynamic performance, freedom of anticoagulation and hemolysis, and is considered to have the ability to grow [3,4,8–11]. However, in addition to the complexity of the insertion technique and the creation of a new pathology in the normal right ventricular outflow tract, long-term performance of the pulmonary valve in the systemic circulation is still unknown.
In the process of the selection of a substitute for the aortic position in children, not only surgical outcomes but also long-term results should be considered carefully. In this study, we retrospectively analyzed our intermediate-term outcome of recent bileaflet mechanical prosthetic valve replacement at the aortic position in children.
| 2. Patients and methods |
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Patients follow-up was done either by referencing patients hospital records or through direct telephone calls. Follow-up period ranged from 1 month to 19.1 years (median; 9.2 years) with complete follow-up rate of 95%. Thirty-seven Doppler echocardiography images including the value of transprosthetic flow velocity were obtained within a 1-year period before the final follow-up. The definition of the events during the follow-up was according to the guideline for reporting valve-related mortality and morbidity after cardiac valvular operations by Edmunds et al. [16].
All data in the text are expressed as the mean ± standard deviation. Time-related changes in survival, freedom from re-replacement of aortic valve and valve-related events were analyzed with the Kaplan–Meier method. Statistical analysis was made using StatView software (Abacus Concept, Inc, Berkeley, CA). A p-value equal or less than 0.05 was considered statistically significant.
| 3. Results |
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As valve-related complications, two episodes of cerebral infarction, two valve thrombosis, two re-replacement of aortic valve, one infective endocarditis, and one sudden death were recognized in five patients. Cerebral infarction occurred in one patient at 1998 when our anticoagulation regimen was aspirin only. After changing our anticoagulation regimen to warfarin, one cerebral infarction was recognized due to withdrawal of warfarin by patient himself. Valve thrombosis occurred twice in the same patient with a therapeutic level of anticoagulation with warfarin. Thrombolysis was successful at the first time (4 years after the aortic valve replacement), while re-replacement of the aortic valve was required at the second time (4.8 years after the aortic valve replacement). Pannus formation under the prosthesis was also observed at the time of re-replacement. Another patient, who had St. Jude Medical valve Hemodynamic Plus series 17 mm with Yamaguchi procedure, required a Ross–Konno procedure 8 years after the initial aortic valve replacement due to prosthesis-patient mismatch associated with pannus formation.
Actuarial survival rate was 92 ± 4% at 15 years after the initial aortic valve replacement with bileaflet mechanical valve. Freedom from re-replacement of aortic valve and valve-related events was 94 ± 4% and 86 ± 6% at 15 years, respectively (Fig. 2 ).
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| 4. Discussion |
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Porcine bioprosthesis and bovine pericardial bioprosthesis do not require permanent anticoagulation, however, they have been almost abandoned for clinical use in small children because of their very early degeneration, calcification and structural failure in young recipients [1–4]. Allograft allows implantation of small size substitutes for neonates and infants, in addition there is the unnecessity of anticoagulation and excellent freedom from anticoagulation-related complications. However, allograft shares the same disadvantage of limited durability as xenograft has [3,5].
Pulmonary autograft (Ross procedure) has become the first choice of aortic valve replacement in children and adolescents in some institutes [3,4,8–11]. Pulmonary autograft shows excellent hemodynamic performance, freedom of anticoagulation and hemolysis, and decreased susceptibility to endocarditis. Pulmonary autograft is also known to have the potential for growth. However, the Ross procedure is a technically demanding procedure, and reoperation for bleeding and postoperative conduction abnormality is not as rare as early complications [11]. Freedom from autograft dysfunction including autograft insufficiency 3+ or more ranges from 75% to 100% depending upon the duration of follow-up [11]. Elkins et al. [17] reported freedom from autograft replacement of 93% and freedom from severe autograft insufficiency or valve-related death of 90% at their 12-year follow-up. The autograft insufficiency is one of the leading cause of reoperation in Ross procedure, and several factors are implicated as risk factors such as preoperative diagnosis of aortic insufficiency, presence of dilated aortic annulus, bicuspid aortic valve, rheumatic heart disease, technical imprecision, the type of insertion, inherent disease of the pulmonary valve, and so on [11].
Elkins et al. [17] reported a freedom from right ventricular outflow tract homograft replacement of 90% at 12 years for children. Rates of freedom from right ventricular outflow tract obstruction were also similar for several authors [18–21]. Because of the diminishing availability of homograft, several conduits are used to reconstruct the right ventricular outflow tract, however, their durability seems to be worse than homograft [11]. Finally, Elkins et al. [17] reported freedom from all valve-related morbidity at 79% at 11 years.
Aortic valve replacement using mechanical prosthetic valves in children often require annular enlargement to insert commercially available prosthesis [6,7]. Nicks procedure [12] enables insertion of prosthesis one size bigger than that of in situ insertion, while Konno procedure [15], Manouguian procedure [14] and Yamaguchi procedure [13] enable insertion of prosthesis two sizes bigger than that of in situ insertion. Konno procedure requires incision of the ventricular septum that might cause ventricular dysfunction or conduction abnormality. In Manouguian procedure, the incision is extended to the anterior mitral leaflet that might cause the mitral insufficiency. Yamaguchi procedure is now our choice of procedure because it does not damage either ventricular septum or mitral leaflet.
Our institutional anticoagulation strategy changed from aspirin to warfarin since 1998 when we had cerebral infarction in one patient. Since we started the new anticoagulation strategy with warfarin, we have not seen any thrombo-embolic events except for two cases, one valve thrombosis associated with pannus formation and the other with cerebral infarction due to warfarin withdrawal by the patient himself. There was no major anticoagulation related hemorrhage. Our freedom from anticoagulation-related events (thrombo-embolism and hemorrhage) at 15 years was 92 ± 4%.
In our study, all patients except for two received bileaflet mechanical prosthetic valve 19 mm or larger in size along with our vigorous application of annular enlargement at the time of initial implantation. Effective valve orifice area index less than 0.85 cm2/m2 is now considered as a criterion of prosthesis-patient mismatch in adults [22], while effective valve orifice area of the prosthesis is different by researchers. In this study, we measured transprosthetic flow velocity by Doppler echocardiography, and plotted these data according to the manufactured valve area index. This revealed that transprosthetic flow velocity does not exceed 300 cm/s in cases with manufactured valve area index more than 1.0 cm2/m2 except for cases associated with pannus formation. It means that, at least in most of our Japanese patients with small body size even in adults, implantation of St. Jude Medical Regent series 19 mm whose manufactured valve area is 2.39 cm2 may not require further re-replacement of the aortic valve unless massive pannus formation develops. Our speculation was compatible with the result of Shanmugan et al. [7] who reported no re-replacement of prosthesis required when the patient received a prosthesis 21 mm or larger in size. The impact of residual pressure gradient across the prostheses on long-term performance of the myocardium is still controversial. Freedom from re-replacement of aortic valve in our series was 94 ± 4% at 15 years, and was at least compatible with the results of other series with mechanical prosthesis by Shanmugan et al. [7] (92% at 20 years), Alexiou et al. [6] (86.4% at 20 years) and Ruzmetov et al. [4] (84% at 19 years), and was not inferior to the results of pulmonary autograft reported by Elkins et al. [17] (93% at 12 years), Turrentine et al. [2] (88% at 7 years), Laudito et al. [23] (83% at 6.6 years) and Pasquali et al. [21] (81% at 8 years). Actuarial survival rate of 92 ± 4% and freedom from valve related complications of 86 ± 6% at 15 years in our series seems quite acceptable, and these results were compatible with recent results after the Ross procedure [2,4,8,19,20,23]. Long-term survival after the aortic valve replacement using bileaflet mechanical prosthetic valve was satisfactory, and an incident rate of late events was low.
This study is retrospective, and the number of patients is relatively small and the follow-up period is not sufficiently long to be conclusive. Our indication for re-replacement of aortic prosthetic valve has not been well established, although left ventricular outflow tract gradient by Doppler echocardiography greater than 40 mmHg [24] is our indication of re-replacement at this moment. Regardless of these limitations, we believe that our study gives useful information to the surgeons to decide their strategy for aortic valve replacement in children.
In conclusion, intermediate-term clinical results of aortic valve replacement in children using bileaflet mechanical prosthetic valve with aortic annular enlargement if necessary was satisfactory. Good hemodynamic performance of recent commercially available bileaflet mechanical prosthetic valve might avoid further re-replacement of the aortic prosthetic valve. Indication of pulmonary autograft insertion at the aortic position, Ross procedure, might be considered carefully in limited cases such as neonate and infants.
| Appendix A |
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Dr W. Daenen (Linden, Belgium): You remarked that seven patients underwent a valve replacement after an arterial switch. What was the interval between the arterial switch and the valve replacement?
Dr Masuda: Im sorry, I dont remember the precise year, but I think these patients received the aortic valve replacement more than 10 years after the arterial switch operation.
Dr C. Sebening (Heidelberg, Germany): I would like to come back a little bit on the point that you just made, Dr Daenen. What is your impression from the cohort of patients after the arterial switch operation as to the mechanism of aortic insufficiency? Many things have been said about it. Was it button-implantation-related or aortic-root-reconstruction-technique-related? What is the impression that you have as to the mechanism of aortic insufficiency in these patients?
Dr Masuda: We assumed that the use of the button technique might be the cause of the aortic regurgitation after the arterial switch operation. We arent sure that this is the precise mechanism, but all of our patients who received the aortic valve replacement had the button technique, so we have started to use the trap-door technique in these days.
Dr Daenen: I was very surprised to see that in two patients, full anticoagulation was either not started or stopped. What was the reason for that?
Dr Masuda: Because one patient received aspirin only and the other patient withdrew warfarin by himself.
Dr Daenen: By himself?
Dr Masuda: Yes.
Dr Daenen: And what was the indication to put him on aspirin only?
Dr Masuda: In the initial era we believed that the bileaflet valve does not need warfarin, and after we had the case of cerebral infarction, we changed our strategy to using warfarin.
Dr Daenen: That was a long time ago.
Dr Masuda: Yes.
Dr S. Mohammadi (Montreal, Quebec, Canada): As you mentioned very well, patient-prosthetic mismatch is a very important issue. This is in growing kids. I have a question for you. Do you have any information about the clinical functional class of these patients, because sometimes we just have clinical mismatch in these patients and you dont need to change it.
Dr Masuda: Almost all patients remained in New York Heart Association functional class I and class II, except for one patient who had a big pressure gradient. We have carefully followed up this patient, but unfortunately this patient moved to another center. I am worried about this patient because we think that this patient should have a redo in the near future.
Dr J. Moll (Lodz, Poland): How large was the group of patients with the arterial switch operation? You had seven patients who needed aortic valve replacement. How large was this group of patients with transposition?
Dr Masuda: In this study group we had only 45 ...
Dr Moll: No, no, this transposition group.
Dr Masuda: For transposition?
Dr Moll: Yes.
Dr Masuda: At this moment I think we have a little bit more than 300 cases for the arterial switch operation.
Dr Moll: Dont you think that it's a large group of patients who required valve replacement?
Dr Masuda: Yes.
Dr Moll: Im surprised you said the results were similar. I have done nearly 500 and only one patient needed to have the valve replaced.
Dr Masuda: That might be caused by the technique of the arterial switch operation which I had mentioned before, the button technique.
Dr Moll: You said about 10 years after the operation?
Dr Masuda: Yes.
Dr G. Sarris (Athens, Greece): Before we move on, just a last comment and a brief question. This is an important paper showing very good results of mechanical valve replacement in children. This is a very important contribution, especially given the increasing awareness of long-term problems with root dilatation after the Ross operation. Given these results from your unit, what is your policy now with performing the Ross operation in children? Is there a place for the Ross operation in your practice?
Dr Masuda: It's different for each surgeon, but I myself, I think very small patients, like neonates and infants, might be the candidates for the Ross operation.
| Footnotes |
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Presented at the 21st Annual Meeting of the European Association for Cardio-thoracic Surgery, Geneva, Switzerland, September 16–19, 2007. | References |
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