A health technology assessment of transcatheter aortic valve implantation (TAVI)—evaluation the methods of effectiveness and safety

Article type
Authors
Chen X1, Li HL1, Yan H1, Zhong D1, Li Y1
1Chinese Cochrane Center, China
Abstract
Background: TAVI is usually performed using transvascular approach through transfemoral approach (TFA) or transsubclavian approach (TSA), or through transapical approach (TAA). There are, however, no systematic data concerning the comparison between the methods of TAVI.

Objectives: We performed a systematic review to assess the safety and effectiveness of TAVI, and identify factors which have effects on important outcomes.

Methods: We searched studies systematically in seven databases from January 2000 to December 2011. We assessed the risk of bias of included studies and extracted data of safety and effieacy. Unadjusted odds ratio (OR), mean difference (MD) and their corresponding 95% CI were pooled to assess the effectiveness and safety of TAVI. The ending of statistical for multiple linear regression included the number of studies ≥3 and the difference is significant.

Results: We identified 12 primary publications (derived from 247 citations) for TAVI that fulfilled the inclusion criteria. The comparison between TVA and TAA, safety indication: 30 days renal failure RR = 0.35 (n = 1487); 30 days MACCEs RR = 2.34 (n = 1225); Effectiveness indication: post-operation mortality RR=0.37 (n=231); 30 days mortality RR = 0.54 (n = 1606); 1 year mortality RR = 0.63 (n = 1408); post-operation gradient change MD = 11.66 (n = 119). Thirty-day mortality inverse proportion with CAD (p = 0.00); 1 year mortality inverse proportion with age (p = 0.00), and direct proportion with Log EuroSCORE (p = 0.00) and PCI (p = 0.00).

Conclusions: Based on the current available comparative data, TVA demonstrates the safety and effctiveness compared with TAA; There is no significant difference of efficacy and safety outcomes for two methods of TVA. However, the sample size of included studies is small, need more high quality research to proves the effectiveness and safety.