Adverse events in contemporary continuous-flow left ventricular assist devices: A multi- institutional comparison shows significant differences  John M.

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Adverse events in contemporary continuous-flow left ventricular assist devices: A multi- institutional comparison shows significant differences  John M. Stulak, MD, Mary E. Davis, MS, Nicholas Haglund, MD, Shannon Dunlay, MD, Jennifer Cowger, MD, Palak Shah, MD, Francis D. Pagani, MD, PhD, Keith D. Aaronson, MD, Simon Maltais, MD, PhD  The Journal of Thoracic and Cardiovascular Surgery  Volume 151, Issue 1, Pages 177-189 (January 2016) DOI: 10.1016/j.jtcvs.2015.09.100 Copyright © 2016 The American Association for Thoracic Surgery Terms and Conditions

Figure 1 Overall survival for patients undergoing HMII (solid line) versus HVAD (dotted line) implantation; no difference was found, with data stratified by device type (P = .96). HMII, HeartMate II; HVAD, HeartWare ventricular assist device. The Journal of Thoracic and Cardiovascular Surgery 2016 151, 177-189DOI: (10.1016/j.jtcvs.2015.09.100) Copyright © 2016 The American Association for Thoracic Surgery Terms and Conditions

Figure 2 Time-related cumulative risk of GI bleeding for patients undergoing HMII (solid line) versus HVAD (dotted line) implantation; no significant difference was found, with data stratified by device type (P = .18). HMII, HeartMate II; HVAD, HeartWare ventricular assist device; GI, gastrointestinal. The Journal of Thoracic and Cardiovascular Surgery 2016 151, 177-189DOI: (10.1016/j.jtcvs.2015.09.100) Copyright © 2016 The American Association for Thoracic Surgery Terms and Conditions

Figure 3 Time-related cumulative risk of any infection for patients undergoing HMII (solid line) versus HVAD (dotted line) implantation; the risk was significantly higher with the HVAD, with stratification by device type (P = .039). HMII, HeartMate II; HVAD, HeartWare ventricular assist device. The Journal of Thoracic and Cardiovascular Surgery 2016 151, 177-189DOI: (10.1016/j.jtcvs.2015.09.100) Copyright © 2016 The American Association for Thoracic Surgery Terms and Conditions

Figure 4 Time-related cumulative risk of percutaneous driveline infection for patients undergoing HMII (solid line) versus HVAD (dotted line) implantation; no difference was found, with data stratified by device type (P = .14). HMII, HeartMate II; HVAD, HeartWare ventricular assist device. The Journal of Thoracic and Cardiovascular Surgery 2016 151, 177-189DOI: (10.1016/j.jtcvs.2015.09.100) Copyright © 2016 The American Association for Thoracic Surgery Terms and Conditions

Figure 5 A, Time-related cumulative risk of stroke for patients undergoing HMII (solid line) versus HVAD (dotted line) implantation; a significantly higher risk of stroke was found with the HVAD, with data stratified by device type (P = .006). B, No significant difference between devices was found in the cumulative risk of transient ischemic attack (P = .69). C, No significant difference was found between devices in the cumulative risk of ischemic stroke (P = .17). D, The cumulative risk of hemorrhagic stroke was significantly higher with the HVAD (P = .006). HMII, HeartMate II; HVAD, HeartWare ventricular assist device. The Journal of Thoracic and Cardiovascular Surgery 2016 151, 177-189DOI: (10.1016/j.jtcvs.2015.09.100) Copyright © 2016 The American Association for Thoracic Surgery Terms and Conditions

Figure 5 A, Time-related cumulative risk of stroke for patients undergoing HMII (solid line) versus HVAD (dotted line) implantation; a significantly higher risk of stroke was found with the HVAD, with data stratified by device type (P = .006). B, No significant difference between devices was found in the cumulative risk of transient ischemic attack (P = .69). C, No significant difference was found between devices in the cumulative risk of ischemic stroke (P = .17). D, The cumulative risk of hemorrhagic stroke was significantly higher with the HVAD (P = .006). HMII, HeartMate II; HVAD, HeartWare ventricular assist device. The Journal of Thoracic and Cardiovascular Surgery 2016 151, 177-189DOI: (10.1016/j.jtcvs.2015.09.100) Copyright © 2016 The American Association for Thoracic Surgery Terms and Conditions

Figure 6 A, Time-related cumulative risk of pump thrombus for patients undergoing HMII (solid line) versus HVAD (dotted line) implantation; no difference was found, with data stratified by device type (P = .35). B, No difference was found in cumulative risk of pump thrombus before (solid line), versus after, August 2011 (dotted line) (P = .33). HMII, HeartMate II; HVAD, HeartWare ventricular assist device. The Journal of Thoracic and Cardiovascular Surgery 2016 151, 177-189DOI: (10.1016/j.jtcvs.2015.09.100) Copyright © 2016 The American Association for Thoracic Surgery Terms and Conditions

Figure 7 Adverse event risk comparison of the HVAD versus the HMII. The HVAD was associated with a higher risk of stroke and any infection, and a trend toward increased percutaneous driveline infection. AE, Adverse event; GI, gastrointestinal; HVAD, HeartWare ventricular assist device; HMII, HeartMate II. The Journal of Thoracic and Cardiovascular Surgery 2016 151, 177-189DOI: (10.1016/j.jtcvs.2015.09.100) Copyright © 2016 The American Association for Thoracic Surgery Terms and Conditions

Figure 8 Competing outcomes are presented for patients after implantation with the HMII left ventricular assist device. The Journal of Thoracic and Cardiovascular Surgery 2016 151, 177-189DOI: (10.1016/j.jtcvs.2015.09.100) Copyright © 2016 The American Association for Thoracic Surgery Terms and Conditions

Figure 9 Competing outcomes are presented for patients after implantation with the HVAD. The Journal of Thoracic and Cardiovascular Surgery 2016 151, 177-189DOI: (10.1016/j.jtcvs.2015.09.100) Copyright © 2016 The American Association for Thoracic Surgery Terms and Conditions

Adverse event risk for the HVAD versus the HMII LVADs. The Journal of Thoracic and Cardiovascular Surgery 2016 151, 177-189DOI: (10.1016/j.jtcvs.2015.09.100) Copyright © 2016 The American Association for Thoracic Surgery Terms and Conditions