Safety and Performance of the Micra VR Leadless Pacemaker in a South Korean Cohort: A Comparison to Global Studies

Figures

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  Figure 1. Electrical parameters by visit. Average pacing capture threshold at 0.24 ms over time (A), average R-wave sensing amplitude over time (B), and average pacing impedance over time (C). Error bars represent mean ± standard deviation.

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  Figure 2. Distribution of EQ-5D-5L responses by visit. Distribution of individual components of the EQ-5D-5L at baseline and follow-up. Responses are graded from no issue to extreme issue. EQ-5D-5L = 5-level EuroQol-5 dimension.

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  Figure 3. EQ-5D visual analog scale by visit. In the left panel, the gray lines indicate individual patient values at each visit while the dark blue line indicates the estimated mean and its 95% confidence interval at each visit. The right panel displays the change from the baseline value to the 12-month follow-up value. In this plot, the red circles indicate individual patient values, and the dark blue dot displays the estimated mean change with error bars representing the 95% confidence interval for the change. EQ-5D-5L = 5-level EuroQol-5 dimension; VAS = visual analog scores.

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  Figure 4. Korean valuation of health status by visit. In the left panel, the gray lines indicate individual patient values at each visit while the dark blue line indicates the estimated mean and its 95% confidence interval at each visit. The right panel displays the change from the baseline value to the 12-month follow-up value. In this plot, the red circles indicate individual patient values, and the dark blue dot displays the estimated mean change with error bars representing the 95% confidence interval for the change. EQ-5D-5L = 5-level EuroQol-5 dimension.

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  Figure 5. Major complication rates through 12 months by Micra VR study. Fine-Gray competing risks were used to compare major complication rates between studies at 12 months. CI = confidence interval; HR = hazard ratio; IDE = Micra VR global IDE study; KOR = Micra VR MAP South Korea study; PAR = Micra VR global post-approval registry study.