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Ann Thorac Surg 2003;76:1078-1083
© 2003 The Society of Thoracic Surgeons
a Division of Cardiology, Utrecht, The Netherlands
b Division of Cardiothoracic Surgery, Wilhelmina Children’s Hospital, University of Utrecht, Utrecht, The Netherlands
* Address reprint requests to Dr Bennink, Wilhelmina Children’s Hospital, Division of Cardiothoracic Surgery, University of Utrecht, PO Box 18009, 3501 CA Utrecht, The Netherlands
e-mail: g.bennink{at}wkz.azu.nl
Presented at the Thirty-ninth Annual Meeting of The Society of Thoracic Surgeons, San Diego, CA, Jan 31–Feb 2, 2003.
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Abstract |
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METHODS: Results after surgical pulmonary valvotomy (with concomitant ASD/VSD closure) (n = 62, age 2.9 ± 3.5 years) and balloon valvuloplasty (n = 108, age 3.6 ± 3.9 years) were analyzed. Transvalvular mean pressure gradient decrease, freedom from reintervention for restenosis, pulmonary valve insufficiency, and tricuspid valve insufficiency were considered.
RESULTS: Mean pressure gradient decreased significantly more in the surgical group (from 64.8 ± 30.8 mm Hg to 12.8 ± 9.8 mm Hg at a mean follow-up of 9.8 years) than after BV (decreasing from 66.2 ± 21.4 mm Hg to 21.5 ± 15.9 mm Hg after a mean of 5.4 years; p < 0.001). Moderate pulmonary valve insufficiency occurred in 44% after surgery, and in 11% after BV (p < 0.001). Tricuspid valve insufficiency occurred in 2% after surgery, and in 5% after BV. Restenosis occurred in 3 surgical patients (5.6%), 2 patients required reoperation, and 1 patient required a balloon valvotomy. Restenosis developed in 13 BV patients (14.1%): 6 patients were redilated and 7 patients required surgery. Surgical valvotomy led to significantly less reinterventions than balloon valvuloplasty (p < 0.04).
CONCLUSIONS: Surgical relief of pulmonary valve stenosis produces lower long-term gradients and results in longer freedom from reintervention. Balloon valvuloplasty may remain, despite these results, the preferred therapy for isolated pulmonary valve stenosis, because it is less invasive, less expensive, and requires a shorter hospital stay. Surgery should remain the exclusive form of therapy in the presence of concomitant intracardiac defects, which need to be addressed.
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Introduction |
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TopAbstractIntroductionMaterial and methodsResultsCommentDiscussionReferences |
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This retrospective study evaluates and compares the long-term results of surgical repair versus balloon valvuloplasty for pulmonary valve stenosis in a homogeneous group of 170 infants and children.
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Material and methods |
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All patients who underwent surgical valvotomy had an associated atrial septal defect (ASD) or ventricular septal defect (VSD), which was addressed during the same operation. Surgical techniques varied widely, and included the closed Brock valvotomy on a beating heart without cardiopulmonary bypass (CPB), as well as various valvuloplasty techniques with CPB and cardioplegic cardiac arrest, performed according to intraoperative findings. After approaching the valve through the pulmonary artery, the pulmonary valve annulus was measured with a Hegar dilator; repairs included mainly commissurotomies and, more rarely, valvotomies; the pulmonary artery was closed directly upon completion of repair. Total valvectomy was not performed, and transannular patches were not inserted.
Balloon valvuloplasty was performed according to established technique [5, 6]. For balloon sizing, a mean ratio of balloon diameter to pulmonary valve annulus of 1.3 was used [12–14]. There were 10 patients in this group with critical neonatal PS. Informed consent was obtained from the parents of each patient.
Patients were classified in two groups according to the treatment performed. Group S consisted of 62 patients who primarily underwent surgery, at a mean age of 2.9 ± 3.5 years (range 0 to 18.0 years old), and group BV consisted of 108 patients who primarily underwent balloon valvuloplasty at a mean age of 3.6 ± 3.9 years (range 0 to 18.1 years old).
Comparison of surgery versus balloon valvuloplasty
Exclusion criteria for both groups were factors complicating the congenital heart defect (n = 11; Noonan’s syndrome) and patients lost to follow-up (n = 13). Therefore, 146 patients met the study criteria, including 54 patients in the surgical group with a mean age of 3.0 ± 3.7 years, and a mean preintervention gradient of 64.8 ± 30.8 mm Hg: 47 patients underwent an open valvotomy with CPB, and 7 patients early in the series underwent the Brock procedure off pump. The BV group consisted of 92 patients with a mean age of 3.2 ± 3.2 years and a mean preintervention gradient of 66.2 ± 21.4 mm Hg. Age and preintervention gradients were not significantly different, making the groups homogeneous. Follow-up ranged from 0.02 to 24.4 years (mean 9.8 years old ± 6.1 years) in S, and from 0.14 to 14.5 years (mean 5.4 years old ± 3.8 years) in BV.
Data collection and analysis
Clinical evaluation was performed before the intervention, immediately after the intervention, and at various intervals. Hemodynamic assessment of the transpulmonary valve pressure gradient and subjective grading of pulmonary and tricuspid regurgitation were determined both preoperatively and at follow-up by Doppler echocardiography. Doppler estimates of gradients were calculated by application of the modified Bernoulli equation to convert continuous-wave Doppler systolic peak flow velocities across the pulmonary valve. Right ventricular hypertrophy and dilatation, pulmonary regurgitation, and tricuspid regurgitation were also measured by echocardiography. Electrocardiograms considered P-pulmonale, right-axis deviation, hypertrophy, and dilatation. Clinical and electrocardiograpfic findings were reviewed at each of the study points.
Pulmonary valve insufficiency (PI) was considered to be absent in patients who had no diastolic murmur on clinical examination and no right ventricular dilatation. Mild PI was characterized by a grade 1 to 2/4 diastolic murmur or Doppler-measured pulmonary regurgitation without right ventricular dilatation; moderate PI was characterized by a grade 2 to 3/4 diastolic murmur or Doppler-measured pulmonary regurgitation together with right ventricular dilatation; severe PI was characterized by the need for surgical intervention, as illustrated by restrictive physiology (diastolic reversal of flow in the pulmonary arteries) by Doppler echocardiography or New York Heart Association (NYHA) functional classes III–IV.
Tricuspid valve insufficiency (TI) was considered absent in patients without clinical and echocardiographic findings; mild TI was characterized by a grade 1 to 2/6 systolic murmur and Doppler-measured tricuspid regurgitation without right atrial dilatation; moderate TI was characterized by a grade 3 to 4/6 systolic murmur and clinical and echocardiographic findings with right atrial dilatation; severe TI was characterized by NYHA functional class IV, for which surgical intervention was needed.
A p value less than 0.05 was considered significant in all statistical analyses. Preoperative and postoperative pressure gradients within groups S and BV were analyzed with an independent samples t-test. Residual pressure gradients were compared between groups S and BV with t-tests (two-tail, unequal variances). Pulmonary valve insufficiency and tricuspid valve insufficiency were statistically evaluated by Fischer’s exact test. Kaplan-Meier curves were constructed and compared to determine the intervention free period in groups S and BV (log-rank analysis).
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Results |
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After BV, the mean pressure gradient was reduced from 66.2 ± 21.4 mm Hg to 23.8 ± 15.8 mm Hg (p < 0.001). Complications in this group included 1 patient (1.1%) with bleeding from the pulmonary artery, 1 patient with a puncture site cutaneous infection (1.1%), and 1 patient with femoral vein thrombosis after cardiac catheterization (1.1%). There was no significant acute arrhythmia or mortality in either group.
Group S versus group BV
A significant difference in postinterventional gradients was apparent between the S and BV groups, in favor of surgery (p < 0.02). The mean length of hospital stay was 11 ± 5 days for surgery (range: 5 to 32 days), compared with 48 hours for balloon valvuloplasty.
Follow-up
Surgery and BV group
The mean transvalvular pressure gradient decreased from 64.8 ± 30.8 mm Hg to 12.8 ± 9.8 mm Hg in the surgical group (p < 0.001) after a mean follow-up time of 9.8 ± 6.1 years (Fig 1A).
At last follow-up, the patients in this group demonstrated predominantly moderate pulmonary valve insufficiency (24 patients, 44%), with 17 patients (31%) having mild PI, and only 13 patients (24%) with no PI. Moderate tricuspid valve insufficiency occurred in 1 patient (2%), 11 patients (20%) had mild TI, and the majority of these patients (41 patients = 78%) developed no TI. Restenosis occurred in 3 patients (5.6%), 2 of these patients were secondarily treated with surgery and 1 patient required balloon valvuloplasty.
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Group S versus group BV
A statistical difference in the long-term mean transvalvular gradient was observed between the groups S and BV, in favor of the surgical group (p < 0.001), although these gradients were trivial (< 30 mm Hg) in both treatment groups (Figs 1A and 1B).
Surgery resulted in more patients with moderate pulmonary valve insufficiency than balloon valvuloplasty (Fischer’s exact test, p < 0.001). There was no significant difference in the occurrence of moderate TI. Log rank analysis revealed a significant lesser number of reinterventions after initial surgical relief of pulmonary valve stenosis (p < 0.04, Fig 2). There was no late arrhythmia or death in either group.
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Comment |
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Although a randomized prospective trial is statistically optimal to compare the two treatment groups, in practice this method is difficult. Studies comparing surgical valvotomy and balloon valvuloplasty are rare [16–18]. O’Conner and coworkers [16] compared the results of balloon dilatation of the pulmonary valve (n = 20) with those of an age- and gradient-matched surgical control group after a follow-up time of 4 to 5 years. They found slightly higher peak instantaneous gradients by Doppler in the balloon group (24 ± 2.7 mm Hg) than in the surgical controls (16 ± 1.5 mm Hg). The incidence of mild pulmonary regurgitation was 45%, and there were no patients with moderate or severe PI in the balloon dilatation group. The incidences of mild and moderate PI were 45% and 45%, respectively, in the surgical controls. These results concord largely with our findings [16]. Rao [17] compared nine representative surgical series with eleven reports of balloon dilatation, and concluded that mortality and morbidity seemed to be greater after surgery. However, the rate of restenosis was higher following balloon dilatation.
Immediate results
Significant reduction of transvalvular pressure gradients can be accomplished with both surgery and BV [8, 14, 19–21], which is confirmed in our study. Evaluation of the gradient immediately after the intervention does reveal a significantly lower gradient in the surgical group. A decrease in the residual gradient could be expected with patient growth, as ventricular hypertrophy decreases and pulmonary flow increases proportionally after both procedures in time.
Follow-up
The mean gradients decreased significantly in both treatments, making both surgery and BV successful procedures. The mean long-term transvalvular pressure gradient of the surgical group was significantly lower than the BV group.
Several studies have reported a high prevalence of pulmonary valve insufficiency (PI) after BV, but none were moderate, nor did anyone require surgical intervention to treat PI [7, 10, 16, 22, 23], with the exception of Berman and associates [15], who reported 6 of 107 patients undergoing balloon pulmonary valuloplasty that required reintervention for insertion of a pulmonary valve owing to right ventricular dilation, at a mean follow-up of 7.2 years. They concluded that younger age (< 3 days), a higher degree of right ventricular obstruction (right/left ventricular systolic pressure ratio before intervention > 1.28), and oversized balloons (balloon/annulus ratio > 1.44) were risk factors for surgical intervention after prior balloon dilation [15]. In our study, 44% of patients in the surgical group and 10% in BV group had moderate PI at follow-up. In 1 patient of the BV group, severe clinical impairments were noted, and this patient eventually required a pulmonary valved homograft. None of the patients in group S with PI required surgical treatment. The clinical relevance of asymptomatic mild to moderate pulmonary valve insufficiency remains a subject of debate, not only in isolated PVS, but also after repair of tetralogy of Fallot involving a transannular patch [24]. Newer follow-up protocols including magnetic resonance imaging scans and plasma neurohormones are stratifying the degree of PI in relation to right ventricular function or dysfunction, in an attempt better to define those asymptomatic patients that will require a reintervention before eventual right ventricular dilatation [25].
Most studies only report the number of patients with PI, but TI is also an important factor to consider after BV, because this can produce an impairment in functional class. Although it seems intuitive that catheter-induced lesions leading to TI could occur only after BV, it is difficult to establish TI as a direct complication of BV, rather than a hemodynamic consequence of concomitant PI.
Study limitations
The retrospective nature of our analysis and the lack of patient randomization are an inherent flaw in study design. Surgical techniques vary greatly and need to be adapted to the underlying anatomy, although it was not the purpose of the study to compare different surgical techniques of pulmonary valvuloplasty.
Conclusions
We found surgical repair of pulmonary valve stenosis to result in significantly less reinterventions in the long-term than balloon valvuloplasty. However, moderate pulmonary valve insufficiency occurred more often in the surgical group, whose significance is not yet defined, because none of these patients have required reintervention and are clinically asymptomatic. The mean preoperative, immediate postoperative period, and long-term transvalvular pressure gradients revealed a statistical difference between surgery and balloon valvuloplasty in favor of surgery, although both treatments were satisfactory (< 30 mm Hg residual gradient).
Balloon valvuloplasty may remain the first choice of treatment of isolated pulmonary valve stenosis because it is less invasive, less expensive, and requires a shorter hospital stay. However, the advantages of surgery, such as a lower long-term gradient and a subsequent lesser need for reinterventions, should be kept in mind. When considering patients with a concomitant ASD or a hemodynamically insignificant VSD who could be treated with either procedure, the better long-term results of surgery may influence preoperative counseling, and should be stressed in informed consent. Even in the current era where a concomitant ASD could be closed with a device during the same catheter intervention session as the balloon valvuloplasty, we currently offer surgery at our institution.
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Discussion |
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TopAbstractIntroductionMaterial and methodsResultsCommentDiscussionReferences |
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The short-term and mid-term results of balloon valvotomy, as you presented, are acceptable, with a 44-mm reduction in the gradient after more than five years in the pulmonary valvotomy group. The late results show only a 9-mm greater gradient reduction in the surgical group than in the pulmonary valvotomy group, that is, 22 versus 13 at latest follow-up, which is statistically significant but not clinically relevant. The balloon valvotomy group had one-fourth the incidence of pulmonary regurgitation than did the surgical group. Reintervention was necessary in 14% of the balloon valvotomy group, versus 6% of the surgical group.
I agree with your conclusions that surgical valvotomy is more precise, has lower long-term gradients, and has less need for reintervention. I too mourn the loss of a surgical procedure to our interventional cardiologists and an operation that allowed us to teach the important tenants of congenital heart surgery to our residents. Balloon valvotomy, however, is less invasive, less expensive, and is currently at our institution an out-patient procedure. I have four questions.
The incidence of pulmonary insufficiency was four times more common with surgery than with balloon valvotomy. Why? I would not have predicted this since this has not been our experience.
The second question, is more pulmonary regurgitation a good tradeoff for mild pulmonary stenosis? We know from our experience in the tetralogy of Fallot group that moderate or severe pulmonary regurgitation will likely require reintervention 10 to 30 years postoperatively.
Not addressed in your presentation was the incidence of ventricular arrhythmia in the two groups. Was this looked at?
And number four, although not addressed in your abstract, what is your management protocol for the more complicated neonate with a pulmonary atresia or critical pulmonary stenosis?
I enjoyed your presentation and compliment you and your colleagues for excellent results and I thank the STS for the privilege of discussing this paper. Thank you.
DR MUHAMMAD A. MUMTAZ (Cleveland, OH): Did you look at right ventricular function in these patients since a lot of them had pulmonary regurgitation after surgery?
DR GERHARD ZIEMER (Tuebingen, Germany): You showed a difference in the incidence of tricuspid valve regurgitation after the different procedures. However, in surgery you also did VSD closure. So if you take out VSD closures or other intraventricular surgery, maybe there is no pulmonary valvotomy-related tricuspid valve insufficiency in surgery.
DR JOHN E. MAYER, JR (Boston, MA): It strikes me that these are actually two quite different patient populations. If I understood your early slide correctly, almost all of the patients who had surgical valvotomy also had at least the anatomic substrate for a left-to-right shunt. In that situation there is going to be increased pulmonary blood flow. There is difficulty in knowing whether or not the pressure gradient that you measured is really related to flow or if it is related to the severity of the anatomic obstruction? I would be interested in knowing whether or not you have pulmonary to systemic flow ratios or absolutely pulmonary blood flow data in the patients who underwent surgical procedures.
In a similar way, the patients who have pulmonary valve insufficiency following their pulmonary valvotomy also have increased flow across the pulmonary valve because of the regurgitant flow. I would be interested in knowing if you have estimates of total systolic pulmonary blood flow in the patients postoperatively?
DR DODGE-KHATAMI: I would like to thank all of the discussants for their questions and comments.
To Dr Brown, the incidence of four times or more pulmonary insufficiency in the surgical group, why? I wouldn’t be able to give an explanation technically as to the why, but I think in one of the slides where we broke down the degree of pulmonary insufficiency (PI), the point I think we are trying to make is that none of these patients in the surgical group, even though they have mild to moderate pulmonary valve insufficiency, have required any type of intervention, are fully asymptomatic and have no medication. So I guess I would answer that question with another question, what does mild or moderate PI really mean and do we have to worry about it? I am not sure. Although the way it was defined by our echocardiographer, there is a difference between the two groups, do we really need to worry about a higher incidence of mild or moderate pulmonary valve insufficiency?
The second question, and that goes along with what I have just tried to explain, is more PI better than mild PS (pulmonary stenosis)? All of the patients that required in either group any type of intervention, be it via balloon dilation or surgical intervention, had that done for pulmonary valve stenosis or restenosis rather than for PI, where nothing really needed to be done. Therefore, I would say that the tradeoff of more PI would be better than PS because it does not necessarily have any repercussions or needs to be addressed.
We did not have any problems with ventricular arrhythmia. This goes along partially with the other question that was asked. There is a small cohort of patients that are neonates who underwent balloon dilation for critical pulmonary stenosis, 10 patients only, where we would have expected to have more problems with ventricular arrhythmia. Fortunately, we did not.
As to the question with right ventricular function, all of these children had echocardiography, and there was no significant difference in right ventricular function between the surgical and the balloon valvuloplasty group. Concerning tricuspid insufficiency (TI) in the surgical group, it was not looked at specifically with regards to the presence or not of a VSD (ventricular septal defect). Either way, there was no significant difference in moderate or severe TI between the two groups, ranging between 0% and 4%.
I believe there were two questions related to flow. In those patients from the surgical group with concomitant ASDs (atrial septal defect) and VSDs, obviously there is a flow problem. There is also a problem with assessing the degree of TI when you do have an associated shunt. We did not perform any MRI (magnetic resonance imaging) studies nor total pulmonary blood flows to distinguish between the two, although I don’t think that was really the aim of the study. I think everybody agrees that for your simple pulmonary valve stenosis, balloon valvotomy is the procedure of choice.
Whether or not there is a small ASD or a VSD, it will not be on the basis, say, of pulmonary flow studies or MRI studies that we would choose for one or the other. If there is an intracardiac defect that needs to be addressed at the same time, it only makes sense to operate and take care of all three problems, and if not, balloon valvuloplasty is definitely the procedure of choice in our institution. Along the same lines, do we have a particular protocol for neonates with critical pulmonary stenosis or pulmonary atresia. In our hospital they are all treated with pulmonary valve dilation and not with surgery.
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