Aortic Valve Reinterventions After Balloon Aortic Valvuloplasty for Congenital Aortic Stenosis: Intermediate and Late Follow-Up

Study Questions:

What is the freedom from aortic valve reintervention, and what are the patient-related and procedural risk factors for reintervention following transcatheter balloon aortic valvuloplasty for congenital aortic stenosis (AS)?

Methods:

This was a retrospective review of all patients undergoing balloon dilation for congenital AS from 1985 to 2008 at a single institution. Patients were excluded if they died within 30 days of the procedure or were converted to a univentricular circulation. The total study cohort consisted of 509 patients. Factors evaluated included: age at initial intervention, isolated native AS, pre- and post-intervention aortic valve function, freedom from aortic valve replacement (AVR), freedom from transcatheter or surgical aortic valve reintervention, and survival.

Results:

The median duration of clinical follow-up was 9.3 years (range 0.1-23.6 years). Age at initial intervention was <1 month (22%), 1-12 months (23%), 1-10 years (27%), 11-15 years (18%), and ≥16 years (10%). Isolated native AS was present in 73% of the cohort. Survival over time was 95% at 5 years, 93% at 10 years, and 88% at 20 years. Survival free from any aortic valve reintervention was 89% at 1 year, 72% at 5 years, 54% at 10 years, 38% at 15 years, and 27% at 20 years. Factors associated with shorter survival free from repeat balloon dilation included age <30 days (hazard ratio [HR], 5.3; p < 0.001), and higher residual AS (per 10 mm Hg) early after intervention (HR, 1.21; p = 0.002). Survival free from any surgical aortic valve reintervention was 82% at 5 years, 69% at 10 years, 58% at 15 years, and 45% at 20 years. Predictors of shorter freedom from surgical reintervention included higher acute post-dilation AS gradient, higher grade of acute post-dilation aortic regurgitation, and the presence of multiple left heart obstructive lesions. In multivariate analysis, lower post-dilation AS gradient and lower grade of post-dilation AR were associated with longer freedom from AVR, but age, era, and pre-dilation aortic regurgitation severity were not.

Conclusions:

Patients with congenital AS who undergo balloon dilation have an ongoing risk for transcatheter or surgical (including AVR) reintervention regardless of age, AS severity, or associated interventions. There is also an ongoing steady hazard for death after an initial steep acute phase. Long-term aortic valve outcomes are primarily a function of the underlying aortic valve disease and acute procedural outcomes. Newborns are at higher hazard for repeat balloon dilation, but not surgical aortic valve reintervention compared to older patients.

Perspective:

Balloon aortic valvuloplasty is highly effective and the initial treatment of choice for congenital AS. Despite early success, there is an ongoing hazard for transcatheter or surgical aortic valve reintervention as well as late mortality. When counseling families, based on this study of balloon aortic valvuloplasty, results at 10 years include the following: 93% of patients will be alive with 54% free from any aortic valve intervention and 69% free from any surgical aortic valve intervention.

Clinical Topics: Cardiac Surgery, Congenital Heart Disease and Pediatric Cardiology, Valvular Heart Disease, Cardiac Surgery and CHD & Pediatrics, Cardiac Surgery and VHD, Congenital Heart Disease, CHD & Pediatrics and Quality Improvement

Keywords: Heart Valve Prosthesis, Infant, Newborn, Balloon Valvuloplasty, Multivariate Analysis, Follow-Up Studies, Heart Defects, Congenital, Heart Valve Diseases, Risk Factors


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