|
|
||||||||
Eur J Cardiothorac Surg 2005;27:807-814
© 2005 Elsevier Science NL
Department of Cardiovascular Surgery, National Cardiovascular Center, 5-7-1 Fujishiro-dai, Suita, Osaka 565-8565, Japan
Received 5 October 2004; received in revised form 17 January 2005; accepted 25 January 2005.
* Corresponding author. Tel.: +81 6 6833 5012; fax: +81 6 6872 7486. (E-mail: yagihara{at}hsp.ncvc.go.jp).
| Abstract |
|---|
|
|
|---|
Key Words: Right ventricular outflow tract reconstruction Homograft Pulmonary valved conduit Polytetrafluoroethylene
| 1. Introduction |
|---|
|
|
|---|
| 2. Materials and methods |
|---|
|
|
|---|
|
2.2. Handmade tri-leaflet conduits
Prior to the operation, a tri-leaflet conduit was manufactured on the operating table. Conduit size was determined to be almost always larger than the anticipated pulmonary valve diameter, if the sternum allowed. Mean conduit size was 21.1±3.1mm (range: 1227mm), 147.4±21.4% (range: 82.6202.6%) of the anticipated diameter of the pulmonary valve (Fig. 1).
|
|
|
)
2.3. Operative techniques
All patients were approached by median sternotomy. Hypothermic extracorporeal circulation with cold antegrade crystalloid cardioplegia was used. If the operation was confined to the right side of the heart, the aorta was not cross-cramped. In 37 patients with non-confluent central pulmonary artery, reconstruction of the central pulmonary artery with heterologous pericardial roll was carried out concomitantly [13]. Surgical correction of the pulmonary artery branches was necessary in 18 patients. The stenotic area was enlarged mostly with a piece of autologous or heterologous pericardial patch, followed by distal anastomosis of the conduit. The distal end of the conduit was trimmed and beveled, and an end-to-end anastomosis between the distal conduit and the proximal pulmonary bifurcation was performed using continuous 6-0 polypropylene sutures. Care was taken to tilt the conduit plane to the pulmonary artery and to create a large anastomosis. We expect this maneuver to not only prevent compression of the valve between the heart and the sternum but to minimize turbulent blood flow. An additional conduit was inserted between the tri-leaflet conduit and the ventriculotomy, tailoring its proximal end in an S-shaped manner so as to avoid a gradient at the transition of the ventriculotomy.
2.4. Patient follow-up
There were 28 early deaths; AVD in 7, VSD and PA with MAPCAs in 6, TGA in 5, DORV in 4, and others in 6. All surviving patients had periodic follow-up at our institution. Follow-up was 100% complete and ranged from 1month to 18 years, with a mean of 8.5±5.9 years. All were given warfarin sodium and low-dose antiplatelet drugs for at least 1 year after conduit implantation.
Recently, routine postoperative catheterization was carried out in most cases at approximately 1 year after the operation. During catheterization, the radiopaque markers attached to the ePTFE leaflets could be easily visualized, allowing convenient assessment of leaflet motion. We assessed the motion of the ePTFE leaflets in 25 conduits.
The indication for reoperation was persistent pressure gradient across the conduit of greater than 50mmHg.
2.5. Echo examinations
All patients were examined in the immediate postoperative period and reexamined serially with transthoracic echocardiograms every 612 months. Pulmonary valve regurgitation (PR) was assessed by looking at the regurgitant jet with pulsed color-flow Doppler; of particular interest was the width of the jet at its source and its penetration depth into the ventricle. PR was graded subjectively as follows: none, slight, mild, moderate, or severe. If PR was equal to or greater than moderate, it was considered to be important. For seven patients the echocardiographic windows were inadequate to allow comment on valve function, and for another three patients serial analysis was unavailable; the echocardiographic follow-up was therefore complete in 206 conduits (95.4%).
2.6. Data analysis
Data are presented as the mean ± the standard deviation. All statistical tests were conducted with JMP 5.1.1 software (SAS Institute, Inc., Cary, NC). The cumulative survival estimates were made by the KaplanMeier method. The log-rank test was applied for comparison between time-related variables. Values of p<0.05 were considered significant.
| 3. Results |
|---|
|
|
|---|
3.2. Reinterventions
Of the 193 survivors, 24 (12.4%) underwent balloon dilatation and 68 (34.2%) required reoperations. Two patients required replacement of an infected conduit. One patient with PA-VSD with MAPCAs, who had an ePTFE tri-leaflet conduit, developed severe aortic valve regurgitation 2 years after the operation. She underwent aortic valve replacement concomitant with conduit replacement using a porcine stentless valve. Although the ePTFE leaflets were pliable and utterly unobstructive in this particular patient, we exchanged the conduit because a more competent valve would be advantageous in the presence of elevated pulmonary vascular resistance and deteriorated ventricular function. Eventually, 65 conduits were replaced due to obstructive disease within 5 months17 years after the primary operation (mean: 8.6±3.3 years). All of these were original valved pericardial rolls (porcine: 37; equine: 21; bovine: 7). The most stenotic portion was associated with calcified pericardial leaflets in 55 conduits and excessive peel formation in 10. Virtually all 47 ePTFE tri-leaflet conduits have been free from calcification or important obstruction over a follow-up period that ranged from 1month7 years (mean: 3.1±0.3 years).
Regarding the techniques of reoperation, the anterior patching method using autologous tissue, as described by Danielson et al. [4,14], was carried out in 38 cases. A second handmade tri-leaflet conduit was inserted in 25 cases, a non-valved tube in 4, and a stentless porcine valve in 1. There were three mortalities associated with reoperation (4.4%). Two patients died from severe neurological complications. One patient died from massive postoperative bleeding due to detachment of the distal anastomosis.
Fig. 3 plots the estimates of freedom from reoperation. At 5, 10, and 15 years this was 93.9±1.9, 61.4±4.5, and 35.5±5.6%, respectively. The freedom from reintervention, including balloon dilatation or reoperation for conduit obstruction, was 92.6±2.1, 52.6±4.6, and 23.3±4.8% at the respective time points.
|
3.3. Pulmonary valve regurgitation
The echocardiographic analysis showed that freedom from important PR was 68.3±3.7% at 5 years, 33.0±4.5% at 10 years, and 21.6±4.9% at 15 years. No significant difference was detected between the leaflet materials (Fig. 4).
|
|
| 4. Discussion |
|---|
|
|
|---|
The difficulty of utilizing homografts and the unsatisfactory results of previous porcine-valved Dacron conduits led us to produce handmade tri-leaflet conduits made of heterologous pericardium. Pericardial conduits have clear advantages in comparison with porcine-valved Dacron conduits. The biological characteristics of the pericardial tissue match quite well with the pulmonary arteries, allowing easier handling and excellent hemostasis at the suture lines. The pericardial conduits are less bulky in the children's chest than are prosthetic valved conduits. Handmade tri-leaflet conduits are, obviously, available in any sizes. The quality of the handmade tri-leaflet conduit was investigated in our earlier series, demonstrating favorable valve function and potential longevity, and we have adopted handmade tri-leaflet conduits as our standard technique for RVOTR, since 1985 [68]. Our present study reveals that long-term durability of our handmade tri-leaflet conduit is comparable to that of the pulmonary homograft conduit; 8494% at 5 years, 80% at 8 years, and 58% at 10 years according to recent literatures. [1517].
With regard to the leaflet material, we initially used porcine pericardium. To obtain better valve function and longer conduit life, we have varied the leaflet material with time. Equine pericardium was employed for the second generation, from 1990, and bovine pericardium for the third generation, from 1993. However, it appeared that no significant improvement was obtained. In general, glutaraldehyde-fixed heterologous pericardium was revealed to have a prominent inflammatory reaction, with calcification and shrinkage. Consequently, in 1996, we quit using heterologous pericardium as the leaflet material and employed ePTFE instead. This material has been used in the form of vascular conduits or to fill defects in many parts of the human body. Experimental and clinical experience indicates that ePTFE causes less calcification, thrombus formation, or intimal hyperplasia than does glutaraldehyde-fixed pericardium [18,19]. These advantages led some groups to employ an ePTFE monocusp in RVOTR [20,21]. Our experience indicates that an ePTFE tri-leaflet conduit can be expected to possess flexible valve behavior along with favorable durability. In early results, the ePTFE leaflets were moving freely and were well tolerated hemodynamically. Conversely, we found that the glutaraldehyde-fixed heterologous pericardial leaflets generally became fixed in the semi-closed or closed position, because of degeneration and calcification, eventually causing significant conduit obstruction. By contrast, when ePTFE leaflets became non-functional, they adhered to the conduit wall and became fixed in the open position without causing significant obstructive deterioration. We believe that ePTFE tri-leaflet conduits may be able to avoid leaflet-related stenotic complication for a lengthy period, if not definitely.
PR has been another concern with the valved conduit [22]. In our study, although the tri-leaflet conduits obviously functioned satisfactorily in the early postoperative phase, PR is ultimately inevitable. The incidence of PR was unrelated to the leaflet material. Certainly PR is malevolent, but it appears that PR was hemodynamically less significant in our study. There was no case that necessitated reoperation due to progressive PR or right ventricular dysfunction. In all cases in need of conduit replacement, conduit obstruction was the dominant lesion and PR was well tolerated. We believe that, although they may be imperfect in the long run, the use of a tri-leaflet conduit is beneficialparticularly for patients with elevated pulmonary vascular resistance or ventricular dysfunction, for whom competent valve function is helpful in the early postoperative period.
Our results show that younger age and smaller conduit size are risk factors for reoperation, as for pulmonary homograft conduits [1517]. In infants or young children, valved conduits inevitably deteriorate and obstruct within the intermediate term. Accordingly, non-conduit repair using autologous tissue has become popular particularly in Japan. This technique may reduce the requirement for reoperation, although right ventricular dysfunction owing to PR might adversely influence the outcome [2325]. Since 1992, our primary techniques of RVOTR for infants and young children have involved autologous tissue reconstruction, such as direct anastomosis between the pulmonary ventricle and the pulmonary artery. We reserve the use of hand-made tri-leaflet conduits for older children and adults.
Our anticoagulant regimen for handmade tri-leaflet conduit, warfarin sodium and low-dose antiplatelet drugs for at least 1 year, is experimental. We sometimes found small old clots inside the fixed leaflets of extirpated conduits. However, we have no case that developed clinically significant pulmonary embolism.
We are still seeking the optimal leaflet material as well as the optimal design, in order to obtain better valve function and longer conduit life. We have made some modifications in the design of the ePTFE tri-leaflet conduit, such as imitation of the natural bulges of the sinuses of Valsalva and the natural thickening of the nodules of Arantius. Although the efficacy of these modifications is not yet determined, we optimistically believe such modifications could make the handmade tri-leaflet conduit even more favorable.
In conclusion, our results show that RVOTR using a handmade tri-leaflet conduit is an acceptable alternative when homograft conduits are not always available. Although questions about long-term durability of the ePTFE leaflets remain unanswered, the intermediate outcomes are encouraging.
| Appendix A. Conference discussion |
|---|
|
|
|---|
The other question: did you use any anticoagulation therapy postoperatively, particularly if you inserted these ePTFE grafts in neonates where you oversized. Probably not all leaflets need to open because of the small stroke volume so that there might be an increased risk of thrombosis.
Dr Koh: All patients are administered warfarin plus low dose of antiplatelet agent for at least one year. For infant, our preferred procedure has been non-conduit repair since 1992. There is no infant having ePTFE tri-leaflet conduit in this series.
And please repeat the first question
Dr Daebritz: It was only about the mean follow-up of the ePTFE graft.
Dr Koh: Mean follow-up of ePTFE tri-leaflet conduits is 2 or 3 years. From 1996, we employed ePTFE leaflets.
Dr R. Deac (Targu-Mures, Romania): I have two questions. First one is, what was the reason to use equine pericardium as the material. And during the utilization have you seen calcification?
Dr Koh: At first we used porcine pericardium for the leaflet material. Next generation was equine pericardium and third generation was bovine pericardium. We were disappointed at the degenerative change of porcine pericardium; but equine pericardium as well as bovine pericardium had similar result, so we abandoned the use of glutaraldehyde-fixed pericardium and employed ePTFE sheet for the leaflet material.
Dr Deac: And the second question, if I may, have you seen in the long-term results in the conduit a kind of neointima deposition, a thickening of the conduit?
Dr Koh: Yes, thickening formation was found in all cases to some extent, but main cause of conduit obstruction was calcified leaflets.
Dr H. Lindberg (Oslo, Norway): I would like to ask you a question about what was the quality of the ePTFE leaflets, is that 0.1, 0.4? And what is the porosity of those leaflets?
Dr Koh: We employ 0.1mm ePTFE sheet.
Dr Lindberg: With no porosity? Because the 0.1 Gore-Tex that we have available in Europe is no porosity, in contrast to the cardiovascular patches which has 50micron porosity.
Dr Koh: I don't understand your question. You're asking about the thickness of the leaflet?
Dr Lindberg: And if they are expanded. Because that 0.1 in Europe is not expanded, it's a solid membrane.
Dr Koh: We use expanded one.
Dr Edmunds: You're talking about the porosity?
Dr Lindberg: The usual porosity of the Gore-Tex membrane is 50microns and the surgical membrane that is available in Europe is no porosity at all.
Dr Koh: Gore-Tex membrane we usually used for pericardial patch.
Dr V. Tsang (London, United Kingdom): I noticed you have gone through three different types of animals for your handmade valve. As we know, the only thing constant in life is change. What would you use conduit wise for your reoperations?
Dr Koh: Indication for the operation?
Dr Tsang: No. What conduits are you going to use for your reoperations?
Dr Koh: Are you asking about the kind of conduit in reoperation?
Dr Tsang: Yes.
Dr Koh: There were 68 reoperations in this series and half of them underwent anterior patching as described by Dr Danielson. The other patients underwent second implantation of tri-leaflet handmade conduit.
| Footnotes |
|---|
Presented at the joint 18th Annual Meeting of the European Association for Cardio-thoracic Surgery and the 12th Annual Meeting of the European Society of Thoracic Surgeons, Leipzig, Germany, September 1215, 2004. | References |
|---|
|
|
|---|
This article has been cited by other articles:
![]() |
N. Papadopoulos, A. Esmaeili, A. Zierer, F. Bakhtiary, F. Ozaslan, and A. Moritz Secondary Repair of Incompetent Pulmonary Valves. Ann. Thorac. Surg., June 1, 2009; 87(6): 1879 - 1884. [Abstract] [Full Text] [PDF] |
||||
![]() |
M. Ando and Y. Takahashi Ten-year experience with handmade trileaflet polytetrafluoroethylene valved conduit used for pulmonary reconstruction. J. Thorac. Cardiovasc. Surg., January 1, 2009; 137(1): 124 - 131. [Abstract] [Full Text] [PDF] |
||||
![]() |
G. R. Nunn, J. Bennetts, and E. Onikul Durability of hand-sewn valves in the right ventricular outlet. J. Thorac. Cardiovasc. Surg., August 1, 2008; 136(2): 290 - 296. [Abstract] [Full Text] [PDF] |
||||
![]() |
W. A. Goetz, T. E. Tan, K. H. Lim, F. Xiong, S. L. H. Salgues, N. Grousson, Y. L. Chua, and J. H. Yeo Autologous pericardial pulmonary conduit with single point attached commissures in a sheep model Eur. J. Cardiothorac. Surg., January 1, 2008; 33(1): 48 - 52. [Abstract] [Full Text] [PDF] |
||||
![]() |
T. Miyazaki, M. Yamagishi, A. Nakashima, K. Fukae, T. Nakano, H. Yaku, and H. Kado Expanded polytetrafluoroethylene valved conduit and patch with bulging sinuses in right ventricular outflow tract reconstruction J. Thorac. Cardiovasc. Surg., August 1, 2007; 134(2): 327 - 332. [Abstract] [Full Text] [PDF] |
||||
![]() |
T. Miyazaki, M. Yamagishi, K. Shuntoh, and H. Yaku An expanded polytetrafluoroethylene-autologous aortic hybrid valve for right ventricular outflow tract reconstruction in the Ross procedure Interactive CardioVascular and Thoracic Surgery, April 1, 2007; 6(2): 163 - 166. [Abstract] [Full Text] [PDF] |
||||
![]() |
M. Koh, T. Yagihara, H. Uemura, K. Kagisaki, I. Hagino, T. Ishizaka, and S. Kitamura Biventricular repair for right atrial isomerism. Ann. Thorac. Surg., May 1, 2006; 81(5): 1808 - 1816. [Abstract] [Full Text] [PDF] |
||||
![]() |
M. Koh, T. Yagihara, H. Uemura, K. Kagisaki, I. Hagino, T. Ishizaka, and S. Kitamura Intermediate Results of the Double-Switch Operations for Atrioventricular Discordance Ann. Thorac. Surg., February 1, 2006; 81(2): 671 - 677. [Abstract] [Full Text] [PDF] |
||||
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
| ANN THORAC SURG | ASIAN CARDIOVASC THORAC ANN | EUR J CARDIOTHORAC SURG |
| J THORAC CARDIOVASC SURG | ICVTS | ALL CTSNet JOURNALS |