Risk for Permanent Pacemaker After TAVI
We conducted a comprehensive MEDLINE search (via Pubmed) to identify potentially relevant literature dealing with PM requirement after TAVI. Data were collected on paper extraction forms by 2 independent investigators. Any discordance between reviewers was resolved by consensus. Given the lack of prospective randomized trials dealing with this topic, all observational single and multicenter studies or registries published in English language from April 2002 to April 2011 were selected using the following search terms: "transcatheter aortic valve replacement" or "transcutaneous aortic valve implantation" or "percutaneous valve implantation" or "pacemaker after TAVI," or "permanent pacemaker implantation." Studies were excluded from analysis if one of the following criteria was present: (1) animal or in vitro studies, (2) case reports, (3) only abstracts published, and (4) studies with <30 patients without a permanent PM before TAVI.
In all selected studies, all data from patients with permanent PM implantation before TAVI were excluded from the analysis.
Statistical evaluation was performed with the Statistical Package for the Social Sciences (SPSS) Version 15.0. Odds ratios were calculated based on pooled results from all studies. Statistical significance for pooled data was calculated using χ-test with binary outcome. A 2-sided P value <0.05 was considered statistically significant. Continuous variables were reported as weighted means ± weighted standard deviation. Summary effects for studies comparing the 2 commercially available types of catheter-based aortic valve prosthesis (Edwards-Sapiens® prosthesis [ESP]; Edwards Lifesciences Corporation, Irvine, CA, USA and CoreValve® prosthesis [CVP]; Medtronic, Minneapolis, MN, USA) were calculated with the fixed-effect or the random-effects model, as appropriate. Odds ratios were logarithmically transformed and weighted for the inverse of variance. For random-effect models, the estimated variance was calculated using the DerSimonian and Laird method. Heterogeneity among the studies was evaluated by means of Q and I statistics. The significance level for the overall estimates of effect was set at P ≤ 0.05.
Methods
Data Collection and Analysis
We conducted a comprehensive MEDLINE search (via Pubmed) to identify potentially relevant literature dealing with PM requirement after TAVI. Data were collected on paper extraction forms by 2 independent investigators. Any discordance between reviewers was resolved by consensus. Given the lack of prospective randomized trials dealing with this topic, all observational single and multicenter studies or registries published in English language from April 2002 to April 2011 were selected using the following search terms: "transcatheter aortic valve replacement" or "transcutaneous aortic valve implantation" or "percutaneous valve implantation" or "pacemaker after TAVI," or "permanent pacemaker implantation." Studies were excluded from analysis if one of the following criteria was present: (1) animal or in vitro studies, (2) case reports, (3) only abstracts published, and (4) studies with <30 patients without a permanent PM before TAVI.
In all selected studies, all data from patients with permanent PM implantation before TAVI were excluded from the analysis.
Statistical Analysis
Statistical evaluation was performed with the Statistical Package for the Social Sciences (SPSS) Version 15.0. Odds ratios were calculated based on pooled results from all studies. Statistical significance for pooled data was calculated using χ-test with binary outcome. A 2-sided P value <0.05 was considered statistically significant. Continuous variables were reported as weighted means ± weighted standard deviation. Summary effects for studies comparing the 2 commercially available types of catheter-based aortic valve prosthesis (Edwards-Sapiens® prosthesis [ESP]; Edwards Lifesciences Corporation, Irvine, CA, USA and CoreValve® prosthesis [CVP]; Medtronic, Minneapolis, MN, USA) were calculated with the fixed-effect or the random-effects model, as appropriate. Odds ratios were logarithmically transformed and weighted for the inverse of variance. For random-effect models, the estimated variance was calculated using the DerSimonian and Laird method. Heterogeneity among the studies was evaluated by means of Q and I statistics. The significance level for the overall estimates of effect was set at P ≤ 0.05.
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