Twenty-Five Year Experience With Balloon Aortic Valvuloplasty for Congenital Aortic Stenosis

doi:10.1016/j.amjcard.2011.05.040

The American Journal of Cardiology

Volume 108, Issue 7, 1 October 2011, Pages 1024-1028

https://doi.org/10.1016/j.amjcard.2011.05.040 Get rights and content

Balloon aortic valvuloplasty (BAV) is the primary therapy for congenital aortic stenosis (AS). Few reports describe long-term outcomes. In this study, a retrospective single-institution review was performed of patients who underwent BAV for congenital AS. The following end points were evaluated: moderate or severe aortic insufficiency (AI) by echocardiography, aortic valve replacement, repeat BAV, surgical aortic valvotomy, and transplantation or death. From 1985 to 2009, 272 patients who underwent BAV at ages 1 day to 30.5 years were followed for 5.8 ± 6.7 years. Transplantation or death occurred in 24 patients (9%) and was associated with depressed baseline left ventricular shortening fraction (LVSF) (p = 0.04). Aortic valve replacement occurred in 42 patients (15%) at a median of 3.5 years (interquartile range 75 days to 5.9 years) after BAV and was associated with post-BAV gradient ≥25 mm Hg (p = 0.02), the presence of post-BAV AI (p = 0.03), and below-average baseline LVSF (p = 0.04). AI was found in 83 patients (31%) at a median of 4.8 years (interquartile range 1.4 to 8.7) and was inversely related to post-BAV gradient ≥25 mm Hg (p <0.04). AI was associated with depressed baseline LVSF (p = 0.02). Repeat valvuloplasty (balloon or surgical) occurred in 37 patients (15%) at a median of 0.51 years (interquartile range 0.10 to 5.15) and was associated with neonatal BAV (p <0.01), post-BAV gradient ≥25 mm Hg (p = 0.03), and depressed baseline LVSF (p = 0.05). In conclusion, BAV confers long-term benefits to most patients with congenital AS. Neonates, patients with post-BAV gradients ≥25 mm Hg, and patients with lower baseline LVSF experienced worse outcomes.

Section snippets

Methods

We queried our institutional database and hospital billing records to identify all patients who underwent BAV from 1984 through 2009. Patients were excluded if they ultimately underwent single-ventricle palliation. Demographic data, including age at catheterization, gender, weight, and associated cardiac lesions, were recorded. Outcomes after BAV were reviewed. The Social Security Death Index was queried to identify all deaths.

The baseline echocardiographic study was defined as the most recent

Results

From 1984 to 2009, 307 patients underwent BAV at our institution. Catheterization reports were not available for 20 patients, and 15 patients ultimately underwent single-ventricle palliation. Thus, a total of 272 patients were included in our study. Patients ranged in age at BAV from 0 days to 30.5 years, with a median age of 3.0 years; 116 patients (42.6%) underwent BAV at age <1 year, including 50 patients (18.4%) who underwent BAV as neonates (age ≤30 days). Surgical valvuloplasty was

Discussion

Our study represents a 25-year experience with balloon valvuloplasty for congenital AS. We found 65% freedom from repeat valvuloplasty, 61% freedom from AVR, and 87% freedom from death or heart transplantation at 15 years after initial BAV. These findings are similar to those of other long-term studies.6, 7, 8, 9, 15 We demonstrated that in patients who have undergone BAV for congenital AS, baseline (pre-BAV) LVSF and significant residual AS are independently associated with clinical outcomes.

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Studies have reported repeat BAV for recurrent stenosis in a substantial number of patients, with freedom from repeat BAV at 10 years ranging from 46% to 70% (44,51). The prevalence and severity of AR increases over time, and 10-year freedom from significant AR as low as 49% has been reported (52). The risk for progressive moderate to severe AR during long-term follow-up has been described in both neonates and older patients (51,53,54).
Transcatheter balloon valvuloplasty for the treatment of aortic and pulmonary valve stenosis was first described nearly 40 years ago. Since that time, the technique has been refined in an effort to optimize acute outcomes while reducing the long-term need for reintervention and valve replacement. Balloon pulmonary valvuloplasty is considered first-line therapy for pulmonary valve stenosis and generally results in successful relief of valvar obstruction. Larger balloon to annulus (BAR) diameter ratios can increase the risk for significant valvar regurgitation. However, the development of regurgitation resulting in right ventricular dilation and dysfunction necessitating pulmonary valve replacement is uncommon in long-term follow-up. Balloon aortic valvuloplasty has generally been the first-line therapy for aortic valve stenosis, although some contemporary studies have documented improved outcomes following surgical valvuloplasty in a subset of patients who achieve tri-leaflet valve morphology following surgical repair. Over time, progressive aortic regurgitation is common and frequently results in the need for aortic valve replacement. Neonates with critical aortic valve stenosis remain a particularly high-risk group. More contemporary data suggest that acutely achieving an aortic valve gradient <35 mm Hg with mild aortic regurgitation may improve long-term valve performance and reduce the need for valve replacement. Continued study will help to further improve outcomes and reduce the need for future reinterventions.
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Hybrid Balloon Valvuloplasty for the Treatment of Severe Congenital Aortic Valve Stenosis in Infants
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Infants aged younger than 90 days with severe CAS or reduced left ventricular systolic function are at high risk for early and late adverse events, including sudden cardiac death [10, 14, 15]. Conventional treatment, such as surgical or percutaneous intervention, of these high-risk patients continues to be undermined by high mortality and morbidity [3, 9–11, 16]. Advantages of a hybrid technique through the ascending aortic approach over percutaneous balloon valvuloplasty include no peripheral vascular injury, decreased technical difficulty, and simultaneous ligation of patent ductus arteriosus and removal of pericardial effusion intraoperatively [17].
Surgical or percutaneous interventional treatment of severe congenital aortic valve stenosis (CAS) in early infancy remains challenging. This single-center, retrospective study analyzed midterm outcomes of a hybrid balloon valvuloplasty procedure through the ascending aorta by way of median sternotomy, including cases with improved technique.
Included were 45 consecutive infants (aged <90 days) with CAS and selected for biventricular repair who underwent hybrid balloon valvuloplasty in a hybrid or ordinary operating room from October 2010 to March 2016. Patients were assessed at 1, 3, 6, and 12 months and yearly thereafter.
Hybrid balloon valvuloplasty was successful in all patients, with the last 8 treated in an ordinary operating room under only echocardiography guidance with a new sheath. Thirty-two patients were successfully rescued from low heart rate or left ventricular systolic dysfunction, or both, by cardiac massage under direct visualization; none required cardiopulmonary bypass. The degree of new aortic insufficiency was mild in 7 patients and changed from mild to moderate in 1 patient. Aortic valve pressure gradient decreased from 70.6 ± 17.5 mm Hg preoperatively to 15.2 ± 4.2 mm Hg immediately postoperatively (p < 0.001). Fluoroscopy time was 4.8 ± 2.3 minutes. At a median of 32.1 months (range, 1 to 68 months) follow-up, all patients were alive and healthy. Aortic valve pressure gradient remained low (19.1 ± 5.2 mm Hg). Left ventricular ejection fraction increased from 0.515 ± 0.134 (range, 0.21 to 0.70) preoperatively to 0.633 ± 0.035 (range, 0.58 to 0.75; p < 0.001). No aortic insufficiency developed, and no patient required reintervention.
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The aim of this study was to evaluate practice patterns and outcomes of a contemporary group of patients undergoing balloon aortic valvuloplasty (BAV) for congenital aortic stenosis (AS).
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Within the IMPACT (Improving Pediatric and Adult Congenital Treatments) Registry, all BAV procedures performed between January 2011 and March 2015 were identified. Procedures were separated into those performed for critical versus noncritical AS. Outcomes were stratified into optimal, adequate, and inadequate, with optimal and adequate outcomes defining “successful” procedures. Multivariate logistic regression was used to identify patient and procedural characteristics associated with unsuccessful BAV. Mortality and adverse events rates were compared across patient cohorts.
Of the 1,026 isolated BAV procedures captured in IMPACT, 718 (70%) were “successful.” Success rates were 70.9% for noncritical AS (n = 916) and 62.7% for critical AS (n = 110). Multivariate analysis revealed that prior cardiac catheterization, mixed valve disease, baseline aortic valve gradient >60 mm Hg, baseline aortic insufficiency greater than mild, presence of a trainee, and multiple balloon inflations were associated with unsuccessful BAV in the noncritical AS cohort. There were no factors associated with unsuccessful procedures in the critical AS group. No procedural deaths occurred, but 2.4% of patients did not survive to hospital discharge. Adverse events occurred in 15.8% of all cases and were more frequent in procedures performed for critical AS (30.0% vs. 14.1%; p < 0.001).
BAV is an effective treatment for congenital AS with low rates of mortality and adverse events. Patients with critical AS have a higher risk for procedure-related adverse events.

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Congenital heart diseaseTwenty-Five Year Experience With Balloon Aortic Valvuloplasty for Congenital Aortic Stenosis

Section snippets

Methods

Results

Discussion

Am J Cardiol

Am Heart J

J Am Coll Cardiol

Am J Cardiol

J Am Coll Cardiol

J Am Coll Cardiol

Ann Thorac Surg

J Am Soc Echocardiogr

J Am Coll Cardiol

Congenital heart disease
Twenty-Five Year Experience With Balloon Aortic Valvuloplasty for Congenital Aortic Stenosis