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Ann Thorac Surg 2002;73:1801-1807
© 2002 The Society of Thoracic Surgeons

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Original article: cardiovascular

One hundred pulmonary valve replacements in children after relief of right ventricular outflow tract obstruction

^a Department of Surgery, Division of Cardiothoracic Surgery, and the Sibley Heart Center, Department of Pediatrics, Division of Pediatric Cardiology, Emory University School of Medicine, Atlanta, Georgia, USA

* Address reprint requests to Dr Kanter, Division of Cardiothoracic Surgery, Emory University School of Medicine, 1365 Clifton Rd, Atlanta, GA 30322, USA
e-mail: kkanter{at}emory.edu

Presented at the Forty-eighth Annual Meeting of the Southern Thoracic Surgical Association, San Antonio, TX, Nov 8–10, 2001.

	Abstract

Top Abstract Introduction Material and methods Results Comment DISCUSSION References

 
Background. Surgical repair of obstructive lesions of the right ventricular outflow tract (RVOT) in children commonly creates pulmonary valve incompetence that may eventually require pulmonary valve replacement (PVR). We reviewed our experience with PVR late after RVOT reconstruction.

Methods. We performed 100 PVRs in 93 children 1.1 months to 22.4 years (median 8) after RVOT reconstruction. Children with right ventricular to pulmonary artery conduits and primary PVRs were excluded. Age at PVR was 4.5 months to 27.9 years (median 9.5 years). Initial diagnosis was tetralogy of Fallot and variants, 62; critical pulmonary stenosis, 15; pulmonary atresia with intact ventricular septum, 7; and others, 9. Eleven patients had a redo PVR. A total of 62 PVRs were homografts; 38 were porcine valves.

Results. There was one early death. On follow-up of 5 months to 12.4 years (mean 4.9 years) there were no late deaths although 1 child underwent cardiac transplantation. Actuarial freedom from redo PVR at 8 years was 100% for porcine valves but 70% for homograft valves (p = 0.17). For children younger than 3 years at PVR, freedom from reoperation was 76% at 1 year and 39% at 8 years compared with freedom from redo PVR at 8 years of 100% for children older than 3 years. On latest echocardiogram 97% of porcine valves had mild or no pulmonary regurgitation compared with 72% of homograft valves.

Conclusions. PVR after RVOT reconstruction can be performed with low risk. Porcine valves may be superior to homograft valves although this advantage may be due to older age at time of PVR.

	Introduction

Top Abstract Introduction Material and methods Results Comment DISCUSSION References

 
Surgical repair of obstructive lesions of the right ventricular outflow tract in children commonly leaves the native pulmonary valve incompetent. Although this generally is well tolerated long term after operation there is a certain percentage of patients who will not do well with longstanding pulmonary insufficiency. They can develop right ventricular failure, progressive right ventricular distension, and even increasing tricuspid regurgitation or ventricular arrhythmias [1]. Many of these patients will benefit from placement of a competent pulmonary valve in the right ventricular outflow tract [2]. We have reviewed our experience with 100 consecutive patients undergoing pulmonary valve replacement late after reconstruction of the right ventricular outflow tract.

	Material and methods

Top Abstract Introduction Material and methods Results Comment DISCUSSION References

 
Patient population
From February 1989 to October 2000 we performed 100 pulmonary valve replacements in 93 children who had undergone previous reconstruction of the right ventricular outflow tract. Children undergoing replacement of right ventricular to pulmonary artery conduits or primary pulmonary valve replacement were excluded from this report. Age at the time of pulmonary valve replacement ranged from 4.5 months to 27.9 years (mean 10.1 ± 6.3 years; median 9.5 years). The time interval from the original repair to the pulmonary valve replacement ranged from 1.1 months to 22.4 years (mean 8.6 ± 5.7 years).

Indications for operation were generally based on the development of symptomatic right ventricular failure. More recently, we have evaluated these children by magnetic resonance (MRI) [3] and echocardiographic assessment. Some apparently asymptomatic patients have undergone pulmonary valve replacement if they developed evidence of severe right ventricular dilatation on MRI (right ventricular to left ventricular volume ratio > 2:1). Other indications in the apparently asymptomatic patient were increasing tricuspid regurgitation in the face of severe pulmonary insufficiency with right ventricular dilatation as well as significant ventricular arrhythmias.

The initial primary diagnosis for the 93 patients in this series is shown in Table 1. A majority of patients had tetralogy of Fallot or variants of tetralogy of Fallot such as absent pulmonary valve syndrome and tetralogy of Fallot with complete atrioventricular septal defect. During this same time period approximately 450 patients underwent complete repair of tetralogy of Fallot at our institution. Because some of the patients undergoing pulmonary valve replacement in this series had their primary operations elsewhere it is difficult to determine the exact percentage of children undergoing repair of tetralogy of Fallot who came to pulmonary valve replacement. Other diagnoses included critical pulmonary stenosis and pulmonary atresia with intact ventricular septum. In both of these categories the initial corrective operation included enlargement of the right ventricular outflow tract with resultant insufficiency of the pulmonary valve either due to aggressive valvotomy or actual valvectomy and transannular patching. Eleven of the 100 patients in this series had repeat pulmonary valve replacement, seven of whom had both pulmonary valve replacements in this series (accounting for 100 pulmonary valve replacements in 93 children).

Operative details
Seventy-two of the 100 patients undergoing pulmonary valve replacement had other surgical procedures at the time of pulmonary valve replacement (Table 2). Forty-four children who had moderate or severe tricuspid regurgitation underwent De Vega tricuspid annuloplasty [4]. Other common procedures performed at the time of pulmonary valve replacement included pulmonary arterioplasty or placement of stents in 28 and closure of usually small residual ventricular septal defects in 11 patients.

Of the 62 children undergoing homograft replacement, 53 had a pulmonary homograft used whereas only 9 had an aortic homograft placed because of evidence that pulmonary valve homografts tend to have longer durability in the right ventricular outflow tract compared with aortic valve homografts [5].

Of the 38 patients undergoing pulmonary valve replacement with a porcine valve, 19 had a Medtronic Freestyle valve (Medtronic Inc, Minneapolis, MN), 17 had a Carpentier-Edwards porcine valve (Edwards Lifesciences, Irvine, CA), and 2 had a Hancock valve (Medtronic Inc, Minneapolis, MN) treated with 2-aminooleic acid (AOA) in hopes of retarding calcification [6]. Comparing the 62 patients who received a homograft with the 38 patients who received a porcine valve, the age at time of pulmonary valve replacement tended to be older in the porcine group. The interval between the initial "corrective" operation to the pulmonary valve replacement tended to be longer. Both of these values did not achieve statistical significance (Table 3). However, the valve size in the homograft group was statistically smaller than the valve size in the porcine group (Table 3, Fig 1). As can be seen in Figure 1, the smallest porcine valve used was 19 mm owing to the lack of a commercially available smaller porcine valve. Although there were 10 patients who received homograft valves smaller that 19 mm, the majority of children undergoing homograft pulmonary valve replacement had sizes ranging from 19 to 23 mm. On the other hand, all of the porcine valve replacements were 19 mm or greater with more than half of them greater than 25 mm.

View larger version (34K): [in this window] [in a new window]   Fig 1. Distribution of valve sizes by valve type. The homograft valves were statistically smaller than the porcine valves (the mean value for each group is shown).

	Results

Top Abstract Introduction Material and methods Results Comment DISCUSSION References

On follow-up of 5 months to 12.3 years (mean 4.9" 2.5 years) there were no late deaths in the 99 perioperative survivors. One patient with severe biventricular dysfunction required cardiac transplantation 17 months after pulmonary valve replacement. These patients were followed up with serial cardiologic examinations and echocardiograms. On the most recent echocardiogram there was no significant difference between homograft valves and porcine valves with respect to pulmonary stenosis (Fig 2). Eighty-two percent of the children with homograft valves had mild or no pulmonary stenosis compared with 86% of children with porcine valves. Twelve percent of patients with homograft valves had moderate pulmonary stenosis and 6% had severe stenosis compared with 14% of the porcine group who had moderate pulmonary stenosis and none who had severe pulmonary stenosis. On the other hand, significant pulmonary insufficiency was more common on the latest postoperative echocardiogram in children receiving homograft valves compared with those receiving porcine valves (Fig 3).

View larger version (33K): [in this window] [in a new window]   Fig 2. Semiquantitative evaluation of degree of pulmonary stenosis evaluated on the most recent postoperative echocardiogram expressed as percent of patients examined. There were no statistically significant differences between homograft valves and porcine valves with respect to late pulmonary stenosis.

View larger version (37K): [in this window] [in a new window]   Fig 3. Semiquantitative evaluation of degree of pulmonary insufficiency evaluated on the most recent postoperative echocardiogram expressed as percent of patients examined. Homograft valves had a statistically higher chance of moderate or severe pulmonary regurgitation compared with porcine valves.

Actuarial freedom from reoperation on the pulmonary valve is shown in Figure 4. The mean follow-up for children with homograft valves was 5.1 ± 2.6 years compared with mean follow-up of 4.5 ± 2.3 years for the children with porcine valves (p = not significant). Disturbingly, there is a small but definite early reoperation rate in the homograft group with 4 of the redo pulmonary valve replacements occurring before 1 year postoperatively. In contrast, there were no reoperations in the porcine group until 8 years after the pulmonary valve replacement.

View larger version (23K): [in this window] [in a new window]   Fig 4. Kaplan-Meier actuarial freedom from reoperation for homograft and porcine valves. Although the p value was 0.17, at 8 years follow-up freedom from reoperation for porcine valves was 100% compared with 70% for homograft valves. (PVR = pulmonary valve replacement.)

View larger version (22K): [in this window] [in a new window]   Fig 5. Kaplan-Meier actuarial freedom from reoperation for children older than 3 years of age compared with children younger than 3 years of age at the time of pulmonary valve replacement. Freedom from reoperation for children younger than 3 years of age was 76% at 1 year and 39% at 8 years. This compares with freedom from reoperation for children older than 3 years of age of 100% at 8 years (p < 0.0001). (PVR = pulmonary valve replacement.)

	Comment

Top Abstract Introduction Material and methods Results Comment DISCUSSION References

Zahka and associates [13] examined 59 patients after tetralogy of Fallot repair with echocardiography and electrocardiography. They found that the presence of ventricular bigeminy and ventricular couplets were related to the severity of pulmonary insufficiency. Similarly, Harrison and colleagues [14] found that adult patients with ventricular tachycardia late after repair of tetralogy of Fallot were more likely to have severe pulmonary insufficiency compared with those without ventricular tachycardia.

With pulmonary valve replacement there does however appear to be improvement in right ventricular function. Bove and coworkers [2] looked at radionuclide right ventricular function and m-mode echocardiography in 11 patients who underwent pulmonary valve replacement late after repair of obstructive lesions of the right ventricular outflow tract. They found improved exercise tolerance and improved right ventricular ejection fraction in 5 of 8 patients whose primary indication for operation was pulmonary insufficiency. Eyskens and colleagues [9] also found improved anaerobic threshold on exercise testing after late pulmonary valve replacement in patients originally with repaired tetralogy of Fallot; this was despite the fact that MRI showed that the right ventricle remained hypocontractile and dilated. Gatzoulis and colleagues [15] also found improved right ventricular ejection fraction with exercise by radionuclide angiography after pulmonary valve replacement late after repair of tetralogy of Fallot.

Finally, Therrien and associates [11] reported on 25 adults late after repair of tetralogy of Fallot who underwent pulmonary valve replacement. They found that right ventricular function by radionuclide angiography did not improve after pulmonary valve replacement. The average interval from tetralogy repair to pulmonary valve replacement was 21.8 years. They argued that for this reason pulmonary valve replacement in these patients should be entertained much earlier.

To summarize, there is good evidence that chronic pulmonary insufficiency after relief of right ventricular outflow tract obstruction will result in significant right ventricular distension and depressed right ventricular function. This may result in left ventricular dysfunction and ventricular arrhythmias. If unattended to, the right ventricular dysfunction may be irreversible even after pulmonary valve replacement. With these points in mind and recognizing that right ventricular function can improve after timely pulmonary valve replacement, we have evolved our policy for reintervention in children and young adults late after reconstruction of the right ventricular outflow tract. Our current indications for pulmonary valve replacement in these patients are an increased right ventricular to left ventricular volume ratio on MRI (> 2:1), increasing tricuspid regurgitation, significant arrhythmias associated with right ventricular dilatation, and symptoms of heart failure.

The short-term results in our series are very acceptable with only 1 operative death unrelated to the cardiac problems. This compares with other published series that similarly show a very low operative mortality [7, 8, 10, 16]. Our hopes are, of course, that placing a competent pulmonary valve will arrest the progression of right ventricular dilatation and the propensity for arrhythmias with subsequent prolonged longevity. Unfortunately the proof for this belief is beyond the scope of this paper. Importantly, 1 patient in our series did go on to cardiac transplantation. Discigil and colleagues [10] from the Mayo Clinic reported 6 late deaths in 42 patients undergoing late pulmonary valve replacement after repair of tetralogy of Fallot. A common cause of late death in patients after repair of tetralogy of Fallot is arrhythmias. The fact that prolongation of the QRS duration on electrocardiogram stabilizes after pulmonary valve replacement [16] supports the philosophy that timely pulmonary valve replacement in patients with severe right ventricular dilatation after reconstruction of the right ventricular outflow tract may prolong survival.

The optimal choice of valve replacement in these patients is not obvious. Although one limited series with short-term follow-up did show success with a tilting disc mechanical valve [17], we have avoided the use of mechanical valves due to the tendency for thrombosis on the right side of the heart [18, 19].

In this series we have chosen biologic valves for pulmonary valve replacement. Earlier experiences with fascia lata [20] valves and unstented xenograft valves [21] were unfavorable. We used homograft valves or porcine valves selected by surgeon preference. Because of lack of readily available porcine valves in small sizes, we used homograft valves in the smaller and younger children. Our preference is to use a pulmonary homograft instead of an aortic homograft because of evidence that they fare better when used for reconstruction of the right ventricular outflow tract in terms of durability [7].

The majority of the porcine valves used in this study were either Carpentier-Edwards valves [22] or Medtronic Freestyle valves [23]. At first glance it appears that the porcine valves in our study lasted longer than homograft valves (Fig 4). However, these differences disappeared when the patients were divided into children undergoing pulmonary valve replacement before the age of 3 and those after the age of 3 (Fig 5). Bando and colleagues [7] also found that homograft valve insertion before the age of 4 was associated with accelerated homograft deterioration, affecting aortic valves more than pulmonary valves. Forbess and colleagues [24] also found that younger age at time of homograft insertion was associated with earlier reoperation. In their series aortic and pulmonary homografts were equally at risk in younger children. A multivariate analysis revealed that this apparent age influence was mostly due to the small size of the valve at the time of insertion.

In our series there were no reoperations for pulmonary valve replacement in children who had homograft valves placed after the age of 3. The only reoperation for pulmonary valve replacement in a patient in the porcine group had her operation performed more than 8 years after pulmonary valve replacement. However, looking at echocardiographic measures of pulmonary stenosis and insufficiency in our series (Figs 2 and 3), the porcine valve appears to function better at intermediate follow-up with statistically less pulmonary insufficiency compared with homograft valves.

Naturally it is important to follow these patients even longer to see if, as time goes on, there are real differences between porcine valves and homograft valves with respect to need for reoperation. There are promising valve substitutes on the horizon such as the SynerGraft homograft valve [25], which may have superior long-term results.

On the basis of our study we now preferentially use porcine valves in children in whom there is room to place these larger valves. We reserve the use of homograft valves (exclusively pulmonary homografts) for two indications. The first indication is for children who are too small to receive a commercially available porcine valve. The second indication is for children who need patch enlargement of the branch pulmonary arteries as was necessary in 28% of this series (Table 2). The natural contour of the pulmonary homograft and extra graft material for pulmonary arterioplasty are quite useful in this situation.

In summary, we have shown that pulmonary valve replacement late after reconstruction of the right ventricular outflow tract can be performed safely with very low operative mortality and no late deaths. The intermediate results are good. Valve reoperations tend to be mainly in children undergoing pulmonary valve replacement before the age of 3 although admittedly the average follow-up in this series is less than 5 years. Functionally porcine valves appear to perform better than homograft valves, particularly with respect to pulmonary insufficiency. At this time the optimal valve replacement for these patients is unclear. Furthermore it is uncertain as to whether replacing a pulmonary valve in these patients does indeed prolong longevity although it is certainly our hope that this is indeed the case.

	DISCUSSION

Top Abstract Introduction Material and methods Results Comment DISCUSSION References

 
DR CONSTANTINE MAVROUDIS (Chicago, IL): That is a very nice paper and very interesting for the people in the audience who are not very conversant about pulmonary valve insertion. Many pioneering surgeons advanced the idea that a right ventricular outflow tract can be enlarged for tetralogy of Fallot and no valve would be necessary. Farouk Idriss started placing pulmonary valves in those tetralogy patients who developed right ventricular dysfunction in the late 1970s and early 1980s. The reviews were mixed at that time; notably it was Frank Spencer who opposed the idea, noting that pulmonary valve insertion would require many reoperations. And so now we have evolved to the idea that pulmonary valve insertion is a good idea for some patients.

As you know, the big problem, however, is not so much placing a pulmonary valve. You and others have demonstrated that it can be done safely. The big problem is when and in whom it should be used. The follow-up studies by Idriss’s group showed that if you replace the pulmonary valve early, it makes a positive difference; the patients get better by measurable criteria. However if the valve is placed late, the results are unpredictable. Whether late pulmonary valve insertion can help to delay or eliminate cardiac transplantation is yet to be proven.

So my question to you is, aside from the fact that you had some loosely defined indications for valve insertion, are there any other indications such as exercise tolerance tests or the like that can help clinicians make decisions for pulmonary valve insertion? As you know, it is a very touchy topic, especially with cardiologists, when to use pulmonary valve insertion. I am sorry I have taken so long with this historical vignette, but I think it is important to review it from time to time just how far we have come with this topic.

I agree that the difficult questions are in whom do we place these valves and when do we do it. Certainly many authors, Bove, the Hopkins group and others, have shown that once you put the pulmonary valve in, the right ventricular function gets better, exercise tolerance gets better, and anaerobic threshold is better. Many different modalities have shown that these children do get better.

However, there is one very alarming paper from Toronto. In this paper, the interval from the original operation to pulmonary valve replacement was over 21 years. Right ventricular function did not get better and those patients developed depressed left ventricular function as a result of their right ventricular dysfunction. So you have to wonder, what is the optimal timing? To date, this is unanswered. We are studying all these patients with MRIs in an attempt to answer that question, but certainly we do not have that information at this time.

(Nashville, TN): Kirk, I very much enjoyed your paper. I think this group is going to be coming back around a few times for us to intervene and thus they represent the index case for adult congenital heart surgery. Once these patients are over 18, pediatric cardiologists may lose sight of them due to insurance issues, they may then be self-referred for symptomatic arrhythmias, which is the way that we usually see these older patients.

Do you think that the maximal VO₂ and other effort-dependent tests are useful for evaluating these patients for pulmonary valve placement? We have been placing the oversized orthotopic bioprosthesis getting away from homografts on the second procedure. From the point of view of your ages, 3 and under, it is probably a homograft problem in so far as size and calcification causing a mismatch early in life. Do you agree? My final question is, is there a way to avoid transannular patches, which are the major subset of patients requiring later surgery? Are you using a different technique early in your repairs?

As with other centers, we are making every effort to avoid a transannular patch; however, there are just a certain subset of patients in whom it cannot be avoided. I think you have condemned these children to eventual pulmonary valve replacement. There was a certain percentage of patients in our series who had pulmonary atresia with intact ventricular septum. I do not know how you can avoid a transannular patch in them. They will all have pulmonary insufficiency. Despite how aggressive you are at avoiding a transannular patch, there is still going to be a cohort of patients after repair who will have long-standing pulmonary insufficiency and a subset of them will come to pulmonary valve replacement.

	References

Top Abstract Introduction Material and methods Results Comment DISCUSSION References

 

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