title: A Decade of Experience With Continuous-Flow Left Ventricular Assist Devices.
abstract: The use of continuous-flow left ventricular assist devices (CF-LVADs) has revolutionized the landscape of mechanical circulatory support for patients with heart failure. Clinical trials are already testing the next generation of CF-LVADs. In this study, our objective was to review our long-term experience with the current generation of CF-LVADs, specifically, the HeartMate (HM) II (Thoratec Corp, Pleasanton, CA). In this single-center retrospective analysis, we evaluated the records of 278 consecutive patients who underwent a total of 302 HM II placements from June 2005 through June 2014. We excluded 11 patients from our final study group, who had previously undergone placement of a HM XVE that failed. We divided the remaining 267 patients into 3 equal groups of 89 patients each, by time period: group 1, June 2005 through May 2009; group 2, June 2009 through January 2012; and group 3, February 2012 through June 2014. To examine differences in survival between our 3 groups, we used time-to-event analysis, including the Kaplan-Meier method. To examine secondary outcomes (including stroke, hemolysis, gastrointestinal bleeding, pump thrombus, and transplant), we used one-way analysis of variance. For our final study group of 267 patients, the total follow-up time was 479.01 patient-years (median, 469 days). The mean age of patients was 57 years; 81.4% were male. In all, 209 (78.9%) patients underwent HM II placement as a bridge to transplant; 58 (21.1%), as destination therapy (DT). The overall survival rate was 94% at 30 days, 77% at 1 year, 65% at 2 years, 60% at 3 years, 50% at 4 years, and 48% at 5 years. In bridge to transplant patients, the survival rate was 78% at 1 year and 66% at 2 years; in DT patients, 70% and 60%. In group 1 patients, the survival rate was 94% at 30 days, 64% at 1 year, and 48% at 2 years; in group 2, 93%, 88%, and 76%; and in group 3, 94%, 77%, and 73% (P = 0.003). In the later years of our study period, from June 2009 onwards (ie, in groups 2 and 3), we noted a statistically significant increase in HM II placement as DT, a reduction of driveline infections, increasing pump exchange, increasing hemolysis, a reduced frequency of transplants, and an improved survival rate (as compared with the earlier group 1). The HM II has favorably influenced the outcomes of patients with end-stage heart failure, yet major complications still limit their survival. Improving compatibility between the pump and the individual host patient, enhancing anticoagulation strategies, and developing a totally implantable pump might further reduce complications thereby improving survival times and allowing CF-LVAD placement to be a true long-term alternative to a heart transplant.
authors.affiliation: Department of Surgery, University of Minnesota, Minneapolis, Minnesota. Electronic address: johnx008@umn.edu.
authors.forename: Ranjit
authors.initials: R
authors.lastname: John
authors.affiliation: Department of Surgery, University of Minnesota, Minneapolis, Minnesota.
authors.forename: Christopher T
authors.initials: CT
authors.lastname: Holley
authors.affiliation: Division of Cardiology, University of Minnesota, Minneapolis, Minnesota.
authors.forename: Peter
authors.initials: P
authors.lastname: Eckman
authors.affiliation: Division of Cardiology, University of Minnesota, Minneapolis, Minnesota.
authors.forename: Samit S
authors.initials: SS
authors.lastname: Roy
authors.affiliation: Division of Cardiology, University of Minnesota, Minneapolis, Minnesota.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Cogswell
authors.affiliation: Department of Surgery, University of Minnesota, Minneapolis, Minnesota.
authors.forename: Laura
authors.initials: L
authors.lastname: Harvey
authors.affiliation: Department of Surgery, University of Minnesota, Minneapolis, Minnesota.
authors.forename: Sara
authors.initials: S
authors.lastname: Shumway
authors.affiliation: Department of Surgery, University of Minnesota, Minneapolis, Minnesota.
authors.forename: Kenneth
authors.initials: K
authors.lastname: Liao
mesh_terms: D000328:Adult; D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000209:etiology; D006333:Heart Failure / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D016027:Heart Transplantation; D006353:Heart-Assist Devices / Q000009:adverse effects; D006461:Hemolysis; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D008910:Minnesota; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D016459:Prosthesis-Related Infections / Q000382:microbiology; D020127:Recovery of Function; D012189:Retrospective Studies; D012307:Risk Factors; D015996:Survival Rate; D013927:Thrombosis / Q000209:etiology / Q000517:prevention & control; D013997:Time Factors; D016896:Treatment Outcome; D016277:Ventricular Function, Left
chemical_list: D000925:Anticoagulants
keywords: circulatory support devices; heart failure; outcomes; surgery (complications)