Transcatheter or surgical treatment of paravalvular leaks: A meta-analysis of 13 studies and 2003 patients.

Background: Significant paravalvular leak is a rare but serious complication of heart valve replacement, leading to symptomatic heart failure and hemolysis. Due to the paucity of comparative data between surgical and transcatheter paravalvular leak correction, we performed a systematic review and meta-analysis of available studies. Methods: Studies comparing transcatheter and surgical treatment of paravalvular leak were systematically identified. Short-term all-cause mortality was the primary outcome. Technical and procedural success, 30-day persistence of significant paravalvular leak, length of hospital stay and long-term mortality, persistence of symptoms and paravalvular leak were the main secondary endpoints. Results: Thirteen studies with 2003 patients were included, treating in most of the cases a mitral prothesis. Transcatheter closure was associated with lower short-term mortality rate (30 days OR 0.28, 95 % CI 0.18-0.42, p < 0.001) compared to surgical treatment. Technical and procedural success did not differ among the two groups. 30-day and long-term rates of persistence of moderate or severe paravalvular leak were higher in the transcatheter group (OR 3.56, 95 % CI 1.49-8.49, p = 0.004 and OR 2.20, 95 % CI 1.27-3.81, p = 0.005 respectively). Long-term death and re-hospitalization events did not differ among the two treatment modalities. The mean difference in days of length of stay was significantly lower in the transcatheter group (mean difference -9.66, 95 % CI -12.37 to -6.94, p < 0.001). Conclusion: Transcatheter closure of paravalvular leaks is associated with lower short-term mortality rates but higher persistence of moderate-severe paravalvular leak and heart failure symptoms at short and long-term follow-up compared to surgical treatment.