title: Effectiveness and Safety of the Impella 5.0 as a Bridge to Cardiac Transplantation or Durable Left Ventricular Assist Device.
abstract: Many patients with end-stage heart failure require mechanical circulatory support as a temporizing measure to enable multidisciplinary assessment for the most suitable therapeutic strategy. Impella 5.0 can be used as a bridge to decision to evaluate patients for potential recovery or bridge to next therapy (bridge to heart transplantation [BTHT] or bridge to durable left ventricular assist device or VAD [BLVAD]. Our goal was to examine single-center outcomes with the Impella 5.0 device as a bridge to next therapy (BTHT or BTLVAD). Forty patients underwent Impella 5.0 support from December 2009 to December 2015 with the intent of BTHT (n = 20) or BTLVAD (n = 20). The primary end point was survival to next therapy. Secondary end points included hemodynamic assessments and in-hospital/30-day complications. All patients were inotrope-dependent, with severely depressed left ventricular ejection fraction (12%) and renal insufficiency (creatinine 2.0 mg/dl). Most were Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) 2 (66%) with biventricular failure (65%). Thirty patients (75%) survived to next therapy, including transplant (n = 13), durable LVAD (n = 15), and recovery of native heart function (n = 2). No strokes or major bleeding events requiring surgery were observed. Acute renal dysfunction, bleeding requiring transfusion, hemolysis, device malfunction, limb ischemia occurred in 13 (33%), 11 (28%), 3 (8%), 4 (10%), and 1 (3%) patients, respectively. Survival rate to discharge and/or 30 days was 68% (27 of 40). Temporary support with the Impella 5.0 allows for an effective bridge to decision strategy for hemodynamic stabilization and multidisciplinary heart team assessment of critically ill patients with heart failure. In conclusion, many of these patients can be subsequently bridged to the next therapy with favorable outcomes.
authors.affiliation: Department of Cardiac and Thoracic Surgery, Baylor University Medical Center, Dallas, Texas. Electronic address: brian.lima@baylorhealth.edu.
authors.forename: Brian
authors.initials: B
authors.lastname: Lima
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Baylor University Medical Center, Dallas, Texas.
authors.forename: Parag
authors.initials: P
authors.lastname: Kale
authors.affiliation: Department of Cardiac and Thoracic Surgery, Baylor University Medical Center, Dallas, Texas.
authors.forename: Gonzalo V
authors.initials: GV
authors.lastname: Gonzalez-Stawinski
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Baylor University Medical Center, Dallas, Texas.
authors.forename: Johannes J
authors.initials: JJ
authors.lastname: Kuiper
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Baylor University Medical Center, Dallas, Texas.
authors.forename: Sandra
authors.initials: S
authors.lastname: Carey
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Baylor University Medical Center, Dallas, Texas.
authors.forename: Shelley A
authors.initials: SA
authors.lastname: Hall
mesh_terms: D005260:Female; D006333:Heart Failure / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D016027:Heart Transplantation; D006353:Heart-Assist Devices; D006801:Humans; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design; D012042:Registries; D012189:Retrospective Studies; D015996:Survival Rate / Q000639:trends; D013781:Texas / Q000453:epidemiology; D016896:Treatment Outcome; D016277:Ventricular Function, Left / Q000502:physiology*