title: Impact of concurrent surgical valve procedures in patients receiving continuous-flow devices.
abstract: BACKGROUND
  Preexisting valve pathology is common in patients with end-stage heart failure undergoing left ventricular assist device (LVAD) placement. The indications and subsequent benefits of performing valvular procedures in these patients are unclear. The objective of this study was to determine the impact of performing concurrent surgical valve procedures in a large cohort of patients receiving LVADs.
  
  
  METHODS
  One thousand one hundred six patients received the HeartMate II (HMII) LVAD in the bridge to transplant (n = 470) and destination therapy (n = 636) clinical trials. Of these, 374 patients (34%) had concurrent cardiac surgery procedures as follows: 242 patients (21%) with 281 concurrent valve procedures (VP) (aortic 80, mitral 45, and tricuspid 156), and 641 patients had only HMII LVAD. The focus of this study was to determine the clinical outcomes of patients undergoing HMII + VP compared with those who received HMII alone.
  
  
  RESULTS
  Patients undergoing HMII + VP were significantly older, had higher blood urea nitrogen levels and central venous pressure, and decreased right ventricular stroke work index; intraoperatively, the median cardiopulmonary bypass times were also longer. The unadjusted 30-day mortality was significantly higher in patients undergoing HMII + VP (10.3% vs 4.8% for LVAD alone, P = .005). Subgroup analysis of individual VPs showed that higher mortality occurred in patients with HMII plus 2 or more VPs (13.5%, P = .04) followed by trends for increased mortality with HMII plus mitral alone (11.5%, P = NS), HMII plus aortic alone (10.9%, P = NS), and HMII plus tricuspid (8.9%, P = NS) procedures. Of these various groups, only patients undergoing HMII + isolated aortic VP (P = .001) and HMII + multiple VPs (P = .046) had significantly worse long-term survival compared with patients undergoing HMII alone. Right heart failure and right ventricular assist device use was increased in patients undergoing VPs, but there was no difference in the incidence of bleeding or stroke.
  
  
  CONCLUSIONS
  Patients frequently require concurrent VPs at the time of LVAD placement; these patients are sicker and have higher early mortality. Furthermore, right ventricular dysfunction is increased in these patients. Further studies to develop selection criteria for concurrent valve interventions are important to further improve clinical outcomes.
authors.affiliation: Cardiothoracic Surgery, University of Minnesota, Minneapolis, Minn. Electronic address: johnx008@umn.edu.
authors.forename: Ranjit
authors.initials: R
authors.lastname: John
authors.affiliation: Cardiothoracic Surgery, Columbia Presbyterian Hospital, New York, NY.
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Naka
authors.affiliation: Cardiothoracic Surgery, Mayo Clinic, Rochester, Minn.
authors.forename: Soon J
authors.initials: SJ
authors.lastname: Park
authors.affiliation: Cardiothoracic Surgery, Ohio State University, Columbus, Ohio.
authors.forename: Chittoor
authors.initials: C
authors.lastname: Sai-Sudhakar
authors.affiliation: Cardiac Surgery, St Vincent's Heart Center, Indianapolis, Ind.
authors.forename: Christopher
authors.initials: C
authors.lastname: Salerno
authors.affiliation: Research and Scientific Affairs, Thoratec Corporation, Pleasanton, Calif.
authors.forename: Kartik S
authors.initials: KS
authors.lastname: Sundareswaran
authors.affiliation: Research and Scientific Affairs, Thoratec Corporation, Pleasanton, Calif.
authors.forename: David J
authors.initials: DJ
authors.lastname: Farrar
authors.affiliation: Cardiothoracic Surgery, Duke University, Durham, NC.
authors.forename: Carmelo A
authors.initials: CA
authors.lastname: Milano
mesh_terms: D000328:Adult; D000368:Aged; D006348:Cardiac Surgical Procedures / Q000009:adverse effects / Q000401:mortality; D002986:Clinical Trials as Topic; D005260:Female; D006333:Heart Failure / Q000150:complications / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D006349:Heart Valve Diseases / Q000150:complications / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D006350:Heart Valve Prosthesis; D006801:Humans; D015994:Incidence; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011183:Postoperative Complications / Q000401:mortality / Q000628:therapy; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D012189:Retrospective Studies; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D016277:Ventricular Function, Left; D016278:Ventricular Function, Right
keywords: 22; 27; 35; AI; BTT; BUN; CVP; DT; HMII; HeartMate II; LV; LVAD; RA; RV; RVAD; RVSWI; TR; VP; aortic insufficiency; blood urea nitrogen; bridge to heart transplant; central venous pressure; destination therapy; left ventricular; left ventricular assist device; right atrial; right ventricular; right ventricular assist device; right ventricular stroke work index; tricuspid regurgitation; valve procedure