Robert L Kormos1, Michael McCall2, Andrew Althouse2, Luigi Lagazzi2, Richard Schaub2, Michael A Kormos2, Jared A Zaldonis2, Christopher Sciortino2, Kathleen Lockard2, Nicole Kuntz2, Elizabeth Dunn2, Jeffrey J Teuteberg2. 1. From Heart and Vascular Institute (R.L.K., A.A., L.L., C.S., J.J.T.); Artificial Heart Program (M.C., R.S., K.L., N.K., E.D.), University of Pittsburgh Medical Center, PA; Department of Bioengineering, Rochester Institute of Technology, NY (M.A.K.); and Department of Engineering, University of Pittsburgh, PA (J.A.Z.). kormosrl@upmc.edu. 2. From Heart and Vascular Institute (R.L.K., A.A., L.L., C.S., J.J.T.); Artificial Heart Program (M.C., R.S., K.L., N.K., E.D.), University of Pittsburgh Medical Center, PA; Department of Bioengineering, Rochester Institute of Technology, NY (M.A.K.); and Department of Engineering, University of Pittsburgh, PA (J.A.Z.).
Abstract
BACKGROUND: Reports of left ventricular assist device (LVAD) malfunction have focused on pump thrombosis. However, the device consists of the pump, driveline, and peripherals, all of which are potentially subject to failure. METHODS: Prospectively collected data were reviewed for all LVAD device malfunctions (DMs) occurring in rotary LVADs implanted at a single center between April 2004 and May 2016. Durable LVADs included 108 Heartmate II (HM II) and 105 HeartWare VAD (HVAD). DM data were categorized according to device type and into categories related to the component that failed: (1) controller, (2) peripheral components, and (3) implantable blood pump or its integral electric driveline. Pump-related events were analyzed as pump-specific (suspected or confirmed thrombosis) or nonpump-specific (driveline failure). DM rates were reported as events per 1000 patient-days, and Cox proportional hazard models were used for time-to-event analyses. Cumulative rates of malfunction were examined for the main components of each type of LVAD. RESULTS: Types of DM included controller failure (30%), battery failure (19%), or patient cable failure (14%), whereas only 13% were because of pump failure. DMs were more common in the HM II device (3.73 per 1000 patient-days versus 3.06 per 1000 patient-days for the HVAD, P<0.01). A higher rate of pump-specific malfunctions was discovered in those implanted with an HM II versus an HVAD (0.55 versus 0.39, respectively; P<0.01) and peripheral malfunctions (2.32 versus 1.78 for the HM II and HVAD, respectively; P<0.01); no difference occurred in the incidence of controller DM between the 2 LVADs. Patients with HVAD were 90% free of a pump-specific malfunction at 3 years compared with 56% for the HM II (log-rank P<0.003). Only 74% of the patients with HM II were free of pump thrombosis at 3 years compared with 90% of the patients with HVAD. Freedom from failure of the integrated driveline was 79% at 3 years for the HM II but 100% for the HVAD (log-rank P<0.02). CONCLUSIONS: Device malfunction is much broader than pump failure alone and occurs for different components at different rates based on the type of LVAD.
BACKGROUND: Reports of left ventricular assist device (LVAD) malfunction have focused on pump thrombosis. However, the device consists of the pump, driveline, and peripherals, all of which are potentially subject to failure. METHODS: Prospectively collected data were reviewed for all LVAD device malfunctions (DMs) occurring in rotary LVADs implanted at a single center between April 2004 and May 2016. Durable LVADs included 108 Heartmate II (HM II) and 105 HeartWare VAD (HVAD). DM data were categorized according to device type and into categories related to the component that failed: (1) controller, (2) peripheral components, and (3) implantable blood pump or its integral electric driveline. Pump-related events were analyzed as pump-specific (suspected or confirmed thrombosis) or nonpump-specific (driveline failure). DM rates were reported as events per 1000 patient-days, and Cox proportional hazard models were used for time-to-event analyses. Cumulative rates of malfunction were examined for the main components of each type of LVAD. RESULTS: Types of DM included controller failure (30%), battery failure (19%), or patient cable failure (14%), whereas only 13% were because of pump failure. DMs were more common in the HM II device (3.73 per 1000 patient-days versus 3.06 per 1000 patient-days for the HVAD, P<0.01). A higher rate of pump-specific malfunctions was discovered in those implanted with an HM II versus an HVAD (0.55 versus 0.39, respectively; P<0.01) and peripheral malfunctions (2.32 versus 1.78 for the HM II and HVAD, respectively; P<0.01); no difference occurred in the incidence of controller DM between the 2 LVADs. Patients with HVAD were 90% free of a pump-specific malfunction at 3 years compared with 56% for the HM II (log-rank P<0.003). Only 74% of the patients with HM II were free of pump thrombosis at 3 years compared with 90% of the patients with HVAD. Freedom from failure of the integrated driveline was 79% at 3 years for the HM II but 100% for the HVAD (log-rank P<0.02). CONCLUSIONS: Device malfunction is much broader than pump failure alone and occurs for different components at different rates based on the type of LVAD.
Authors: Amit Alam; Christo Mathew; Elie Dib; Aayla Jamil; Cesar Guerrero-Miranda; Brian Lima; Dan Meyer; Aldo Rafael; Shelley Hall; Susan Joseph Journal: Methodist Debakey Cardiovasc J Date: 2021-03-25
Authors: Kevin Pilarczyk; Udo Boeken; Andreas Beckmann; Andreas Markewitz; P Christian Schulze; Martin Pin; Ingo Gräff; Sebastian Schmidt; Birk Runge; Hans-Jörg Busch; Michael R Preusch; Nils Haake; Gereon Schälte; Jan Gummert; Guido Michels Journal: Anaesthesist Date: 2020-04 Impact factor: 1.041
Authors: Evgenij V Potapov; Christiaan Antonides; Maria G Crespo-Leiro; Alain Combes; Gloria Färber; Margaret M Hannan; Marian Kukucka; Nicolaas de Jonge; Antonio Loforte; Lars H Lund; Paul Mohacsi; Michiel Morshuis; Ivan Netuka; Mustafa Özbaran; Federico Pappalardo; Anna Mara Scandroglio; Martin Schweiger; Steven Tsui; Daniel Zimpfer; Finn Gustafsson Journal: Eur J Cardiothorac Surg Date: 2019-08-01 Impact factor: 4.191