title: Long-term follow-up after implantation of the Shelhigh® No-React® complete biological aortic valved conduit.
abstract: OBJECTIVE
  Long-term follow-up reports after implantation of the Shelhigh® (Shelhigh, Inc., NJ, USA) No-React® aortic valved conduit used for aortic root replacement do not exist.
  
  
  METHODS
  Between November 1998 and December 2007, the Shelhigh® No-React® aortic valved conduit was implanted in 291 consecutive patients with a mean age of 69.6 ± 9.1 years, and 33.7% were female (n = 98). Indications were annulo-aortic ectasia (n = 202), aortic valve stenosis combined with ascending aortic aneurysm (n = 67), acute type A aortic dissection (n = 29), endocarditis (n = 26) and other related pathologies (n = 48) including 62 patients with previous cardiac surgery. Data from two cardiac institutions were analysed retrospectively using SPSS (SPSS Software IBM, Inc., 2014, NY, USA).
  
  
  RESULTS
  Operative mortality was 10% (n = 29). Main cause of death was cardiac failure in 15 patients (51.8%), neurological events in 6 patients (20.7%), respiratory failure in 4 patients (13.8%), bleeding complications in 2 patients (6.9%) and gastrointestinal ischaemia in 2 cases (6.9%). There were 262 hospital survivors and all were entered in the follow-up study (100% complete). During the long-term follow-up (mean 70.3 ± 53.1 in months), a total of 126/262 patients (44.3%) died. Main causes of death in patients after discharge were cardiac (n = 37, 14.1%), neurological (n = 15, 5.7%) respiratory (n = 12, 4.6%), endocarditis (n = 12, 4.6%) and peripheral vascular disease (n = 5, 1.9%). In 29 (11.1%) patients, the cause of death could not be determined. Reoperation was required in 25 (8.6%) patients due to infection of the conduit (n = 9), aortoventricular disconnection (n = 4), pseudoaneurysm formation (n = 4) and structural valve degeneration (n = 8). Reoperations were performed 5.0 ± 3.8 (range 0.1-11.7) years after index surgery.
  
  
  CONCLUSIONS
  The Shelhigh® No-React® aortic valved conduit showed satisfactory short-term operative results. However, the long-term follow-up revealed a relatively high rate of deaths, which may be explained by the epidemiology of the patient group, but a substantial proportion of deaths could not be clarified. The overall rate of reoperation (8.6%) during the mid-term follow-up is worrisome and the failures due to aortoventricular disconnection, endocarditis and pseudoaneurysm formation remain unexplained. The redo-procedures were technically demanding. We recommend close follow-up of patients with the Shelhigh® No-React® aortic valved conduit, because besides classical structural valve degeneration, unexpected findings may be observed.
authors.affiliation: Department of Cardiovascular Surgery, Inselspital, University of Berne, Bern, Switzerland david.reineke@insel.ch dr.d.reineke@gmail.com.
authors.forename: David C
authors.initials: DC
authors.lastname: Reineke
authors.affiliation: Department of Cardiothoracic Surgery, St Antonius Hospital, Nieuwegein, Netherlands.
authors.forename: Abdullah
authors.initials: A
authors.lastname: Kaya
authors.affiliation: Department of Cardiovascular Surgery, Inselspital, University of Berne, Bern, Switzerland.
authors.forename: Paul P
authors.initials: PP
authors.lastname: Heinisch
authors.affiliation: Department of Cardiovascular Surgery, Inselspital, University of Berne, Bern, Switzerland.
authors.forename: Berna
authors.initials: B
authors.lastname: Oezdemir
authors.affiliation: Department of Cardiovascular Surgery, Inselspital, University of Berne, Bern, Switzerland.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Winkler
authors.affiliation: Department of Cardiovascular Surgery, Inselspital, University of Berne, Bern, Switzerland.
authors.forename: Christoph
authors.initials: C
authors.lastname: Huber
authors.affiliation: Department of Cardiothoracic Surgery, St Antonius Hospital, Nieuwegein, Netherlands.
authors.forename: Robin H
authors.initials: RH
authors.lastname: Heijmen
authors.affiliation: Department of Cardiothoracic Surgery, St Antonius Hospital, Nieuwegein, Netherlands.
authors.forename: Wim
authors.initials: W
authors.lastname: Morshuis
authors.affiliation: Department of Cardiovascular Surgery, Inselspital, University of Berne, Bern, Switzerland.
authors.forename: Thierry P
authors.initials: TP
authors.lastname: Carrel
authors.affiliation: Department of Cardiovascular Surgery, Inselspital, University of Berne, Bern, Switzerland.
authors.forename: Lars
authors.initials: L
authors.lastname: Englberger
mesh_terms: D000293:Adolescent; D000328:Adult; D000359:Aftercare; D000368:Aged; D000369:Aged, 80 and over; D017545:Aortic Aneurysm, Thoracic / Q000401:mortality / Q000601:surgery; D001022:Aortic Valve Insufficiency / Q000401:mortality / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000401:mortality / Q000601:surgery*; D001705:Bioprosthesis; D004696:Endocarditis / Q000209:etiology / Q000401:mortality; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000379:methods* / Q000401:mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
keywords: Aortic valve; Complete biological conduit; Long-term outcome; Root replacement