9-01: The multicenter TAVI Brazilian Registry & the need for permanent pacemaker following transcatheter aortic valve implantation. Incidence, predictors and clinical outcomes

Background: Transcatheter aortic valve implantation (TAVI) has demonstrated favorable clinical outcomes, although development of high-degree atrioventricular block requiring permanent pacemaker (PPM) implantation is a frequent complication. The aim of this study was to evaluate the incidence, contributing factors and clinical outcomes of PPM implantation after TAVI procedures.

Methods: Data from 819 patients with severe aortic stenosis from 22 centers included in the Brazilian TAVI registry between January 2008 and January 2015 were reviewed. After excluding patients who died during the procedure, those with a previous PPM and those that implanted Inovare™ prosthesis, 670 patients were analyzed. Multivariate regression was performed to identify predictors of PPM implantation following TAVI. ROC curve analysis was used to measure the ability of the risk factors as predictors.

Results: At 30 days, 135 patients (20.1%) required PPM implantation. There was a decline in the rate of PPM implantation, from 25.5% in 2012 to 15.8% in 2015 (p= 0.005). Patients requiring PPM were more likely to be older (82.5 vs. 81.1 years, p= 0.047), and male (59.3%; p= 0.003), but with similar surgical risk scores between groups. The majority of PPMs were implanted during the first 7 days following the TAVI. Those in the PPM group more frequently received CoreValve™ devices (88.1% vs. 70.8%, p= <0.001), and had previous right bundle branch block (RBBB, 27.3% vs. 6.6%, p= <0.001). On multivariate analysis baseline RBBB (OR, 6.19; 95% CI, 3.56–10.75; p= <0.001), CoreValve™ vs. Sapien XT™ (OR, 3.16; 95% CI, 1.74–5.72; p= <0.001), and mean trans-aortic gradient >50mmHg (OR, 1.86; 95% CI, 1.08–3.2; p= 0.025) were independent predictors of PPM implantation. The estimated risk for PPM insertion is 4% when none of the current risk factors are present, reaching up to almost 63% when all of them are present (Figs. 1 & 2). The current model of predictors showed a good ability to predict PPM implantation: 0.69 (95% CI, 0.64- 0.74) in the ROC curve. Hospital lenght of stay was significantly prolonged for the PPM group (mean= 15.7 +/- 25.7 days for the PPM group vs. 11.8 +/- 22.9 days for the no PPM group; p <0.001), but neither all-cause death (26.7% PPM group vs. 25.6% PPM group; p= 0.80) or cardiovascular death (14.1% vs. 14.8% PPM group and no PPM group respectively; p= 0.84) were affected by PPM implantation. Sub-study of echocardiograms during follow-up denoted worsened recovery of systolic function over time in the PPM group compared against their counterparts without PPM (p= 0.001 at 1 year).

Conclusion: The present study identified pre-existing RBBB, mean aortic gradient that exceeds 50mmHg and CoreValve™ device implantation as independent predictors of the need for PPM implantation at 30-days after TAVI. PPM implantation occurred in approximately one of every 5 TAVI cases and prolonged hospital length of stay, but did not affect all-cause or cardiovascular mortality. PPM implantation was unfavorably associated with worsened recovery of left ventricular ejection fraction, which deserves further investigation.

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