Key result
Performing 3 or more balloon inflations during PBAV increased 1-year repeat procedure-free survival to 94.5% (P=0.009), but did not significantly improve 1-year mortality compared to 1 inflation.
Why the study?
Does a higher number of balloon inflations during percutaneous balloon aortic valvuloplasty improve 1-year survival or reduce the need for repeat procedures in patients with severe aortic stenosis?
Cohort (n=388)
No
Does a higher number of balloon inflations during percutaneous balloon aortic valvuloplasty improve 1-year survival or reduce the need for repeat procedures in patients with severe aortic stenosis?
Absolute Event Rate: 46.1% vs 28.8%
Performing 3 or more balloon inflations during percutaneous balloon aortic valvuloplasty reduces the need for repeat procedures within 1 year, although it does not significantly improve 1-year mortality.
More inflations during PABV associated with higher repeat-procedure-free survival; leaves open optimal technique pending prospective trials.
BACKGROUND: Percutaneous balloon aortic valvuloplasty (PBAV) is a palliative therapeutic option for relief of severe aortic stenosis (AS) in patients that are poor surgical or transcatheter aortic valve replacement (TAVR) candidates or as a bridge to definitive therapy. The outcomes following PBAV are highly variable and studies identifying factors that correlate with outcomes are sparse. The purpose of this study was to identify predictors at the time of the index procedures that can predict 1-year survival or need for repeat PBAV. METHODS: Demographic and procedural information of 505 PBAVs performed on 388 patients from January 1999 to December 2012 at the Deborah Heart and Lung Center were reviewed. Procedural data were compared across many variables and outcomes to identify predictors of outcomes. These predictors were statistically compared using chi-squared tests or Student's t-test. RESULTS: Of the 388 patients analyzed, 145 (37.4%) expired within 1 year following the index procedure. The cohort was then stratified into 3 groups based on the number of balloon inflations. They were similar with regard to baseline characteristics. The mean age was 81.9 ± 9 years. Males constituted 51% of the cohort. Patients who underwent 2 and 3+ inflations had a 47.6% and 93.0% increase in the postprocedural aortic valve area compared to patients who had only 1 inflation. Patients who underwent 3+ inflations were significantly less likely to require a repeat PABV within a year and the repeat procedure free survival rate of 94.5% (P = 0.009). Despite improvement in valve area, there was no statistically significant difference in 1 year mortality between the groups (28.8% vs 42.9% vs 46.1% for 1 vs 2 vs 3+ inflations, respectively). CONCLUSIONS: PBAV provides a modest improvement in valve function and continues to be a safe and feasible option in experienced hands for select patients that are high risk for surgery or TAVR. The use of additional inflations during PBAV resulted in better long-term outcomes.
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Gajanana et al. (2016) conducted a cohort in Severe aortic stenosis (n=388). 3 or more balloon inflations vs. 1 balloon inflation was evaluated on 1-year mortality. Performing 3 or more balloon inflations during PBAV increased 1-year repeat procedure-free survival to 94.5% (P=0.009), but did not significantly improve 1-year mortality compared to 1 inflation.
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