Catheter Cardiovasc Interv. 2012 Oct 1;80(4):663-72.
Safety and efficacy of balloon pulmonary valvuloplasty: A Multicenter Experience.
Holzer RJ, Gauvreau K, Kreutzer J, Trucco SM, Torres A, Shahanavaz S, Bergersen L.
METHODS: Prospective data collection. C3PO Registry. Cases performed between 02/07 and 06/10 at eight institutions. The registry was queried for cases of isolated BPV.
RESULTS:
211 cases were included (45%, Less than 1 month old).
Procedural success was achieved in 91% procedures, being defined as one of the following:
(i) post-BPV peak systolic valvar gradient to < 25 mm Hg (88%),
(ii) decrease in gradient by 50% (79%), or
(iii) reduction of RV/systemic pressure ratio by 50% (45%).
Procedural success was more common in neonates, when compared to older patients (96% vs. 87%, P = 0.03).
Procedure failure - Risk factors included (i) moderate or severe pulmonary valve thickening (OR 2.9, CI 1-8.3), and (ii) presence of supravalve PS (OR 9.6, CI 2.7-33.8).
Adverse events:
Low severity AEs (levels 1-2) occurred in 9% of patients.
Higher severity AEs (levels 3-5) occurred in 3% of patient.
No deaths.
Risk factors for any AE (levels 1-5) were (i) age below 1 month (OR 3.5, CI 1.3-8.9) and (ii) operator experience of less than 10 years (OR 3.8, CI 1.5-9.9).
CONCLUSIONS: Procedural success is common and AEs, especially higher severity AEs, are rare for BPV in patients with isolated PS. Results have improved considerably when compared to historical data.
© 2012 Wiley Periodicals Inc.
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