Author + information
- aSidra Cardiac Program, Sidra Medical & Research Center, Doha-Qatar and Weill Cornell Medicine, New York, New York
- bDivision of Pediatric Cardiology, Our Lady’s Children’s Hospital, Dublin, Ireland
- ↵∗Address for correspondence:
Prof. Ziyad M. Hijazi, Department of Pediatrics, Sidra Cardiac Program, Sidra Medical & Research Center, Doha, Qatar.
Since its introduction by Lababidi in 1983 (1,2), balloon aortic valvuloplasty (BAV) remains palliation of choice for congenital aortic valve stenosis (AS). Current indications for intervention as developed by the American Heart Association (3) include:
• Newborns with isolated critical valvar AS who are ductal dependent, or children with isolated valvar AS who have depressed left ventricular systolic function;
• Children with isolated valvar AS who have a resting peak systolic valve gradient (by catheter) of >50 mm Hg, and children with isolated valvar AS who have a resting peak systolic valve gradient (by catheter) of >40 mm Hg if there are symptoms of angina or syncope or ischemic ST-T-wave changes on electrocardiography at rest or with exercise.
• Children or adolescents with a resting peak systolic valve gradient (by catheter) of >40 mm Hg, but without symptoms or ST–T-wave changes if the patient desires to become pregnant or to participate in strenuous competitive sports, or in an asymptomatic patient with a catheter-obtained peak systolic gradient of <50 mm Hg when the patient is heavily sedated or anesthetized if a nonsedated Doppler study finds the mean valve gradient to be >50 mm Hg.
Many studies have documented outcomes with BAV for congenital AS. Perhaps the largest such group of studies was the VACA (Valvuloplasty and Angioplasty of Congenital Anomalies) registry (4,5) in the late 80s and early 90s. The latest VACA registry study reported on 606 patients (5) who underwent BAV between 1984 and 1992 in 23 institutions. In that study, the short-term success rate of reducing the gradient across the aortic valve to ≤35 mm Hg was 60%. Risk factors for a suboptimal procedure included: younger age (<3 months); higher pre-dilation valve gradient; use of smaller balloons (balloon/annulus ratio <0.9); presence of unrepaired coarctation of the aorta, and an earlier date of procedure.
In this issue of JACC: Cardiovascular Interventions, Boe et al. (6), reported on the short-term success of BAV and factors influencing the success or failure of the procedure in the current era. The IMPACT (Improving Pediatric and Adult Congenital Treatments) registry is a relatively new NCDR (National Cardiovascular Data Registry) collecting prospective data on patients with congenital heart disease undergoing catheter interventions. In this study, 1,126 BAV procedures were recorded from January 2011 to March 2015. One hundred of those procedures were excluded from the analysis, predominantly due to incomplete data. Of the remaining 1,026 procedures, the majority (916 procedures) were performed for noncritical AS. The success rate (optimal = pressure gradient ≤35 mm Hg and no aortic incompetence, and adequate = pressure gradient ≤35 mm Hg and +1 or no worsening of aortic regurgitation) in patients with noncritical AS was higher than those with critical AS (70.9% vs. 62.7%) with an overall success rate of 70%, which compares favorably with the short-term results of the VACA registry (5). Factors influencing the success/failure of the procedure in the noncritical group as identified by this study included: prior cardiac catheterization, mixed valve disease (AS with insufficiency), baseline aortic valve gradient >60 mm Hg, baseline aortic insufficiency >mild, presence of a trainee, and multiple balloon inflations. However, there were no factors identified in the study that lead to success/failure of the procedures specifically in the critical AS group.
Despite the improvement in the technical aspects of the procedure along with newer balloon technology and advancements in critical care, 25 patients did not survive to hospital discharge (2.4% mortality). Both in-hospital and 30-day mortality were higher in the critical group than the noncritical group. The overall incidence of adverse events was surprisingly high at 15.8%, with 11.5% having major events. Patients with critical AS had a higher percentage of total adverse events (30.0% vs. 14.1%; p < 0.001), and major adverse events (27.3% vs. 9.6%; p < 0.001). Significantly higher rates of vascular complications (9.1% vs. 1.2%; p < 0.001), tamponade (2.7% vs. 0.1%; p < 0.001), and subsequent cardiac catheterization (3.6% vs. 0.1%; p ≤ 0.001) were found in patients with critical AS and contributed to the high adverse event rate in this population.
And so we are left with some soul searching to do in relation to balloon aortic valvuloplasty, particularly in neonates with critical AS. Does surgery provide a more predictable result? A recent meta-analysis has suggested earlier need for re-intervention following BAV compared with surgery, which is relevant in a disease that will ultimately require repeated surgical interventions, none of which are optimal (7). The paper by Boe et al. (6) also highlights some of the major limitations of the IMPACT registry, most importantly the lack of standardization of approach to BAV, lack of verification of success/failure/adverse events for each case, and finally, the lack of data points beyond hospital discharge. This latter point becomes very important when reviewing patients needing surgery not related to the catheter intervention and, of course, the need to report on the mid-and long-term success rates of these procedures. Equally, data are not provided on whether the number of cases performed in a particular center has an impact upon outcomes, and it may be that if we are committed to improving outcomes for BAV, it will be as important to review the cases where outcomes were optimal to determine whether the anatomic and technical aspects of these cases can be prioritized. It is surprising that valve leaflet morphology was not associated with less likelihood of success in this study.
As practicing interventional cardiologists, we believe an overall success rate of 70% leaves much room for improvement. We may need to consolidate our efforts by standardizing our approach to achieve this. It is likely that better selection of cases and meticulous attention to details may increase success rates and reduce adverse events. The association of trainee involvement with poorer outcomes is troubling and may reflect a laissez-faire attitude to this condition. This fact needs to be examined more and analyzed further to make solid recommendations regarding the involvement of trainees in such procedures. Ultimately, we believe a randomized trial with surgical valvotomy including longer-term follow-up is warranted to ensure we do not spend another 30 years in the dark as to the optimal approach for this troublesome disease. Our surgical colleagues are very keen on participating in such a trial. We owe it to our patients and their families to answer this question once and for all: is BAV as good, better, or inferior to surgical aortic valvotomy?
↵∗ Editorials published in JACC: Cardiovascular Interventions reflect the views of the authors and do not necessarily represent the views of JACC: Cardiovascular Interventions or the American College of Cardiology.
Prof. Hijazi has been a consultant for and received honoraria from NuMED. Dr. Kenny has reported that he has no relationships relevant to the contents of this paper to disclose.
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