Paolo C Colombo1, Mandeep R Mehra2, Daniel J Goldstein3, Jerry D Estep4, Christopher Salerno5, Ulrich P Jorde3, Jennifer A Cowger6, Joseph C Cleveland7, Nir Uriel8, Gabriel Sayer8, Eric R Skipper9, Francis X Downey10, Masahiro Ono11, Robert Hooker12, Anelechi C Anyanwu13, Michael M Givertz2, Claudius Mahr14, Ia Topuria15, Sami I Somo15, Daniel L Crandall15, Douglas A Horstmanshof16. 1. Columbia University Medical Center, New York, NY (P.C.C.). 2. Brigham and Women's Hospital, Boston, MA (M.R.M., M.M.G.). 3. Montefiore Einstein Center for Heart and Vascular Care, Bronx, NY (D.J.G., U.P.J.). 4. The Cleveland Clinic, OH (J.D.E.). 5. St. Vincent Heart Center, Indianapolis, IN (C.S.). 6. Henry Ford Health System, Detroit, MI (J.A.C.). 7. University of Colorado School of Medicine, Denver (J.C.C.). 8. University of Chicago School of Medicine and Medical Center, IL (N.U., G.S.). 9. Carolinas Medical Center, Charlotte, NC (E.R.S.). 10. St. Luke's Medical Center, Milwaukee, WI (F.X.D.). 11. Methodist Hospital, San Antonio, TX (M.O.). 12. Tampa General Hospital, FL (R.H.). 13. Mount Sinai Hospital, New York, NY (A.C.A.). 14. University of Washington Medical Center, Seattle (C.M.). 15. Abbott, Chicago, IL (I.T., S.I.S., D.L.C.). 16. Integris Baptist Medical Center, Oklahoma City, OK (D.A.H.).
Abstract
BACKGROUND: The MOMENTUM 3 study (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3) has demonstrated that the HeartMate 3 (HM3) pump is associated with reduced strokes compared with the HeartMate II (HMII) device. We now perform a comprehensive analysis of stroke events to evaluate their longitudinal occurrence, clinical correlates, patterns, and impact on outcome across the 2-year duration of support. METHODS: MOMENTUM 3 is a randomized controlled trial of the HM3 centrifugal-flow pump versus the HMII axial-flow pump in patients with advanced heart failure, regardless of the intended goal of support (bridge to transplantation or destination therapy). Baseline and postimplantation clinical correlates of stroke events were assessed with multivariable analyses. Longitudinal patterns, including device association, type of stroke (hemorrhagic versus ischemic), changing severity of impairment assessed with the modified Rankin Scale (disabling [modified Rankin Scale score >3] versus nondisabling [modified Rankin Scale score ≤3]) over time, and association with outcome, were determined. RESULTS: In 361 patients with the intended implant (189 HM3 and 172 HMII), 65 strokes (40 ischemic strokes and 25 hemorrhagic strokes) occurred in 52 patients at a median of 131 (range, 1-733) days. No difference in stroke rate was noted between 0 and 180 days of follow-up between devices. However, stroke incidence in the long-term period (181-730 days after left ventricular assist device) was 3.3 times lower for the HM3 group (HM3: 0.04 versus HMII: 0.13 events per patient-year; odds ratio, 0.23; 95% CI, 0.08-0.63; P=0.01). Treatment with the HM3 pump was the only independent predictor of lower stroke events. We found no direct association of blood pressure or antithrombotic regimens with observed stroke rates. A stroke event significantly lowered 2-year postimplantation survival regardless of subtype or initial severity of neurological impairment compared with patients without a stroke (43±12% for hemorrhagic stroke, 57±9% for ischemic stroke, 51±11% for disabling, and 51±11% for nondisabling compared with 85±2% 2-year survival for patients without stroke). CONCLUSIONS: The HM3 pump is associated with a marked reduction in stroke rates compared with the HMII device, with benefits observed in the long-term period (>6 months). The occurrence of stroke of any type (hemorrhagic and ischemic) or of any functional severity (disabling and nondisabling) is predictive of a poor 2-year clinical outcome. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov/ . Unique identifier: NCT02224755.
RCT Entities:
BACKGROUND: The MOMENTUM 3 study (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3) has demonstrated that the HeartMate 3 (HM3) pump is associated with reduced strokes compared with the HeartMate II (HMII) device. We now perform a comprehensive analysis of stroke events to evaluate their longitudinal occurrence, clinical correlates, patterns, and impact on outcome across the 2-year duration of support. METHODS: MOMENTUM 3 is a randomized controlled trial of the HM3 centrifugal-flow pump versus the HMII axial-flow pump in patients with advanced heart failure, regardless of the intended goal of support (bridge to transplantation or destination therapy). Baseline and postimplantation clinical correlates of stroke events were assessed with multivariable analyses. Longitudinal patterns, including device association, type of stroke (hemorrhagic versus ischemic), changing severity of impairment assessed with the modified Rankin Scale (disabling [modified Rankin Scale score >3] versus nondisabling [modified Rankin Scale score ≤3]) over time, and association with outcome, were determined. RESULTS: In 361 patients with the intended implant (189 HM3 and 172 HMII), 65 strokes (40 ischemic strokes and 25 hemorrhagic strokes) occurred in 52 patients at a median of 131 (range, 1-733) days. No difference in stroke rate was noted between 0 and 180 days of follow-up between devices. However, stroke incidence in the long-term period (181-730 days after left ventricular assist device) was 3.3 times lower for the HM3 group (HM3: 0.04 versus HMII: 0.13 events per patient-year; odds ratio, 0.23; 95% CI, 0.08-0.63; P=0.01). Treatment with the HM3 pump was the only independent predictor of lower stroke events. We found no direct association of blood pressure or antithrombotic regimens with observed stroke rates. A stroke event significantly lowered 2-year postimplantation survival regardless of subtype or initial severity of neurological impairment compared with patients without a stroke (43±12% for hemorrhagic stroke, 57±9% for ischemic stroke, 51±11% for disabling, and 51±11% for nondisabling compared with 85±2% 2-year survival for patients without stroke). CONCLUSIONS: The HM3 pump is associated with a marked reduction in stroke rates compared with the HMII device, with benefits observed in the long-term period (>6 months). The occurrence of stroke of any type (hemorrhagic and ischemic) or of any functional severity (disabling and nondisabling) is predictive of a poor 2-year clinical outcome. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov/ . Unique identifier: NCT02224755.
Authors: Kara R Melmed; Konrad H Schlick; Brenda Rinsky; Oana M Dumitrascu; Oksana Volod; Mani Nezhad; Matthew M Padrick; Carmelita Runyan; Francisco A Arabia; Jaime D Moriguchi; Patrick D Lyden; Shlee S Song Journal: J Neuroimaging Date: 2020-02-10 Impact factor: 2.486
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Authors: Onoja M Akpa; Akinkunmi P Okekunle; Bruce Ovbiagele; Fred S Sarfo; Rufus O Akinyemi; Albert Akpalu; Kolawole W Wahab; Morenikeji Komolafe; Reginald Obiako; Lukman F Owolabi; Godwin Ogbole; Bimbo Fawale; Adekunle Fakunle; Christianah M Asaleye; Cynthia O Akisanya; Dambatta A Hamisu; Luqman Ogunjimi; Abiodun Adeoye; Okechukwu Ogah; Dan Lackland; Ezinne O Uvere; Moyinoluwalogo M Faniyan; Osahon J Asowata; Osimhiarherhuo Adeleye; Mayowa Aridegbe; Taiwo Olunuga; Isah S Yahaya; Adeniji Olaleye; Benedict Calys-Tagoe; Mayowa O Owolabi Journal: J Clin Hypertens (Greenwich) Date: 2021-01-23 Impact factor: 3.738