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Surgery results in better long-term outcomes than balloon valvuloplasty in neonates and infants with congenital aortic stenosis, according to a single-center analysis published online August 21, 2013, ahead of print in the Journal of the American College of Cardiology. Surgery extends relief from stenosis and is more likely to allow patients to delay or avoid reintervention.

Investigators led by Yves d’Udekem, MD, PhD, of Royal Children’s Hospital (Melbourne, Australia), reviewed data on 67 neonates and 56 infants treated at their hospital for congenital aortic valve stenosis between 1977 and 2009. The initial procedure was balloon valvuloplasty in 37 patients and surgery in 86, with similar preprocedural peak gradients in the treatment groups (78 ± 22 mmHg and 69 ± 29 mmHg, respectively). Seventeen of the patients also underwent 19 concomitant procedures.

Low Early, Late Mortality

There were 4 early deaths (3% hospital mortality), 3 after surgery and 1 following balloon dilation. Over a follow-up of 10 ± 7 years, there were 12 late deaths (10%), 8 among patients who first had surgery and 4 in those with an initial balloon angioplasty. Overall survival from the time of intervention was 88% at 10 years and 80% at 20 years. On univariate analysis, the factors most associated with late mortality were:

• Endocardial fibroelastosis (HR 10.3; 95 % CI 3.3-32; P < 0.001)
• Concurrent diagnosis of heart failure (HR 4.7; 95% CI1.4-16; P = 0.02)
• Aortic annulus size (HR 0.6; 95% CI 0.3-0.96; P = 0.035)

Of 119 hospital survivors, 54 (45%) required reintervention. Five repeat procedures occurred during the initial hospital stay, of which 4 came in the wake of unsuccessful balloon valvuloplasty and 1 was due to residual stenosis after surgery. Overall, 35 patients underwent 1 reintervention, 11 patients received 2, and 3 patients had 3 reinterventions each.

Reintervention Less Common, More Delayed After Surgery

At last follow-up, 64% of the surgical group remained free of reintervention vs. 38% of the balloon dilation group. Median time to reintervention was 11 months after balloon valvuloplasty and 5 years after surgery. Ten years after the initial intervention, freedom from reintervention was 27% for balloon dilation and 65% for surgery. Multivariable analysis identified 2 factors that predicted reintervention:

• Having balloon valvuloplasty as the primary procedure (HR 4.0; 95% CI 2.1-7.7; P < 0.001)
• Undergoing initial treatment as a neonate (HR 3.0; 95% CI 1.6-5.6; P = 0.001)

The same 2 factors also predicted the combined endpoint of restenosis or reintervention.

Thirty-five patients (35% of the valvuloplasty group and 26% of the surgery group) underwent valve replacement. Having a unicuspid valve at the time of intervention was a strong predictor of the need for replacement (P < 0.001). Freedom from replacement was 83% at 5 years and 55% at 20 years.

Aortic valve gradient decreased significantly (P < 0.001) and similarly (about 38 mmHg) after both valvuloplasty and surgery. At a mean follow-up of 8.7 years, 24% of balloon valvuloplasty patients vs. 45% of surgical patients remained free of reintervention with less than moderate regurgitation and stenosis. On multivariate analysis, 2 factors increased the odds of that status:

• Having balloon valvuloplasty (HR 3.2; 95% CI 1.8-5.7; P < 0.001)
• Being a neonate at the time of initial intervention (HR 2.2; 95% CI 1.3-3.6; P = 0.002)

The Benefit of Postponing Surgery

According to the authors, the “vast majority” of centers currently favor balloon valvuloplasty, “likely because the initial decision is in the hands of cardiologists, who are the first physicians to care for the patients, and because the expertise in balloon valvuloplasty has been easier to develop than advanced surgical techniques.”

But the surgical approach has come a long way in recent years, they note, with surgeons “now realizing that in order to achieve a more durable repair it is necessary to debulk the leaflets from all thickening and nodular dysplasia and to resuspend with patches the incised unsupported portion of the leaflets.”

Dr. d’Udekem and colleagues say the benefits of the 2 approaches “should not only be weighed in terms of reintervention rates but, more importantly, in terms of the proportion of patients who may have a subsequent surgery postponed for several decades. [By the end of follow-up,] close to half of the patients who underwent surgery were living with a nonstenotic, nonregurgitant native valve, a much higher proportion than if they had undergone an initial balloon valvuloplasty.” Delaying reintervention by several years compensates for the invasiveness of surgery, they assert.

Moreover, the researchers add, the majority of transcatheter patients ultimately end up with valve replacement because of the “destructive nature of balloon valvuloplasty.” Often replacement involves an autograft, which fails within 2 decades in about one-quarter of patients. In contrast, they note, surgery may allow growth of the aortic root, which in turn may allow for the more durable ‘inclusion’ technique at a later age.

Therapy Not ‘One Size Fits All’

In an accompanying editorial, Carl L. Backer, MD, of Children’s Memorial Hospital (Chicago, IL), notes that the study, which is unique in providing a perspective from a center where both therapies were offered over a long period, “appears to be pushing the pendulum back towards surgical intervention.” Furthermore, he underscores the authors’ observation that surgeons now often perform additional procedures that “may lead to improved outcomes over balloon dilation in properly selected cases.”

Yet the study is susceptible to selection bias, Dr. Backer comments. In addition, the investigators “appear to have essentially abandoned balloon dilation in 2006,” he said, while the past 7 years “have seen steady improvement in the techniques of cardiac catheterization, including better imaging, smaller French catheters, and higher pressure balloons, while surgical technique seems to have hit a ceiling.

Dr. Backer also points to the observation from earlier series that valve morphology has a major impact on outcome. For example, the surgical approach may hold an advantage for infants with a tricuspid leaflet, he notes.

Surgery and balloon valvuloplasty should be viewed as complementary approaches to congenital aortic stenosis, Dr. Backer suggests, observing that “in selected cases improved results can be achieved with a surgical valvotomy [while] there are clearly many patients who may be better served by initial balloon dilation.”

The keys to choosing the optimal therapy for a particular patient are critical evaluation of the valve morphology and collaboration between surgeons and interventional cardiologists, he concludes.

 

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Sources:
1. Siddiqui J, Brizard CP, Galati JC, et al. Surgical valvotomy and repair for neonatal and infant congenital aortic stenosis achieves better results than interventional catheterization. J Am Coll Cardiol. 2013;Epub ahead of print.

2. Backer CL. Infant congenital aortic valve stenosis: The pendulum swings [editorial]. J Am Coll Cardiol. 2013;Epub ahead of print.

 

 

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