James K Kirklin1, David C Naftel2, Susan L Myers2, Francis D Pagani3, Paolo C Colombo4. 1. Kirklin Institute for Research in Surgical Outcomes, University of Alabama, Birmingham, Alabama. Electronic address: jkirklin@uabmc.edu. 2. Kirklin Institute for Research in Surgical Outcomes, University of Alabama, Birmingham, Alabama. 3. Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor, Michigan. 4. Division of Cardiology, New York-Presbyterian Hospital, Columbia University, New York, New York.
Abstract
INTRODUCTION: Adverse events, especially strokes, during the implantation of continuous flow durable left ventricular assist devices (LVADs) remain the major barriers to greater application among patients with ambulatory advanced heart failure. METHODS: Between June 2014 and June 2017, a total of 9,489 patients in the Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support database received 10,285 continuous flow LVADs, with follow-up through June 2018. RESULTS: During the follow-up period, 1,515 (16%) patients suffered 1 or more strokes, with a nearly equal frequency of ischemic and hemorrhagic etiology. The risk of stroke was about 4% in the first month, 9% during the first 6 months, and 14% in the first year. By multivariable hazard function analysis, the major risk factors identified in the early phase were LVAD centrifugal flow device and concomitant cardiac surgery, whereas in the constant phase (longer term), a history of repeated non-compliance was most associated with a stroke event. Using a modulated renewal model, the occurrence of an ischemic and especially a hemorrhagic stroke dominated as risk factors for subsequent mortality. Six-month survival after an ischemic stroke was 70%, and after a hemorrhagic stroke, it was <50%. Disabling stroke as judged by Modified Rankin Score was associated with significantly worse survival at 1 and 2 years compared with strokes with mild or no early disability. CONCLUSIONS: This study confirms the 20% incidence of stroke over the first 2 years with axial flow and hybrid (magnetic and hydrodynamic) levitated centrifugal flow pumps. This study suggests a major increase in 1- and 2-year mortality among those with an initial disabling vs non-disabling stroke. To better understand the impact of strokes after implantation and the effect of prevention and intervention strategies, we need more complete Modified Rankin Scores and quality of life data during the stroke recovery period.
INTRODUCTION: Adverse events, especially strokes, during the implantation of continuous flow durable left ventricular assist devices (LVADs) remain the major barriers to greater application among patients with ambulatory advanced heart failure. METHODS: Between June 2014 and June 2017, a total of 9,489 patients in the Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support database received 10,285 continuous flow LVADs, with follow-up through June 2018. RESULTS: During the follow-up period, 1,515 (16%) patients suffered 1 or more strokes, with a nearly equal frequency of ischemic and hemorrhagic etiology. The risk of stroke was about 4% in the first month, 9% during the first 6 months, and 14% in the first year. By multivariable hazard function analysis, the major risk factors identified in the early phase were LVAD centrifugal flow device and concomitant cardiac surgery, whereas in the constant phase (longer term), a history of repeated non-compliance was most associated with a stroke event. Using a modulated renewal model, the occurrence of an ischemic and especially a hemorrhagic stroke dominated as risk factors for subsequent mortality. Six-month survival after an ischemic stroke was 70%, and after a hemorrhagic stroke, it was <50%. Disabling stroke as judged by Modified Rankin Score was associated with significantly worse survival at 1 and 2 years compared with strokes with mild or no early disability. CONCLUSIONS: This study confirms the 20% incidence of stroke over the first 2 years with axial flow and hybrid (magnetic and hydrodynamic) levitated centrifugal flow pumps. This study suggests a major increase in 1- and 2-year mortality among those with an initial disabling vs non-disabling stroke. To better understand the impact of strokes after implantation and the effect of prevention and intervention strategies, we need more complete Modified Rankin Scores and quality of life data during the stroke recovery period.
Authors: Palak Shah; Melana Yuzefpolskaya; Gavin W Hickey; Khadijah Breathett; Omar Wever-Pinzon; Van-Khue Ton; William Hiesinger; Devin Koehl; James K Kirklin; Ryan S Cantor; Jeffrey P Jacobs; Robert H Habib; Francis D Pagani; Daniel J Goldstein Journal: Ann Thorac Surg Date: 2022-01-07 Impact factor: 4.330
Authors: Imad M Hariri; Todd Dardas; Manreet Kanwar; Rebecca Cogswell; Igor Gosev; Ezequiel Molina; Susan L Myers; James K Kirklin; Palak Shah; Francis D Pagani; Jennifer A Cowger Journal: J Heart Lung Transplant Date: 2021-07-24 Impact factor: 10.247