title: Causes of death from the randomized CoreValve US Pivotal High-Risk Trial.
abstract: Explore causes and timing of death from the CoreValve US Pivotal High-Risk Trial.
  
  
  
  An independent clinical events committee adjudicated causes of death, followed by post hoc hierarchical classification. Baseline characteristics, early outcomes, and causes of death were evaluated for 3 time periods (selected based on threshold of surgical 30-day mortality and on the differences in the continuous hazard between the 2 groups): early (0-30 days), recovery (31-120 days), and late (121-365 days).
  
  
  
  Differences in the rate of death were evident only during the recovery period (31-120 days), whereas 15 patients undergoing transcatheter aortic valve replacement (TAVR) (4.0%) and 27 surgical aortic valve replacement (SAVR) patients (7.9%) died (P = .025). This mortality difference was largely driven by higher rates of technical failure, surgical complications, and lack of recovery following surgery. From 0 to 30 days, the causes of death were more technical failures in the TAVR group and lack of recovery in the SAVR group. Mortality in the late period (121-365 days) in both arms was most commonly ascribed to other circumstances, comprising death from medical complications from comorbid disease.
  
  
  
  Mortality at 1 year in the CoreValve US Pivotal High-Risk Trial favored TAVR over SAVR. The major contributor was that more SAVR patients died during the recovery period (31-121 days), likely affected by the overall influence of physical stress associated with surgery. Similar rates of technical failure and complications were observed between the 2 groups. This suggests that early TAVR results can improve with technical refinements and that high-risk surgical patients will benefit from reducing complications.
authors.affiliation: Department of Thoracic and Cardiac Surgery, El Camino Hospital, Mountain View, Calif. Electronic address: Vgaudiani@Pccvs.com.
authors.forename: Vincent
authors.initials: V
authors.lastname: Gaudiani
authors.affiliation: Department of Cardiovascular Surgery, University of Michigan Hospitals, Ann Arbor, Mich.
authors.forename: G Michael
authors.initials: GM
authors.lastname: Deeb
authors.affiliation: Department of Interventional Cardiology, Beth Israel Deaconess Medical Center, Boston, Mass.
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Popma
authors.affiliation: Department of Cardiovascular Surgery, Mount Sinai Health System, New York, NY.
authors.forename: David H
authors.initials: DH
authors.lastname: Adams
authors.affiliation: Department of Cardiothoracic Surgery, University of Pittsburgh, Pittsburgh, Pa.
authors.forename: Thomas G
authors.initials: TG
authors.lastname: Gleason
authors.affiliation: Division of Cardiac Surgery, Johns Hopkins Hospital, Baltimore, Md.
authors.forename: John V
authors.initials: JV
authors.lastname: Conte
authors.affiliation: Cardiovascular Research Institute, University of Kansas, Kansas City, Kan.
authors.forename: George L
authors.initials: GL
authors.lastname: Zorn
authors.affiliation: Interventional Cardiology, St Vincent Medical Center, Indianapolis, Ind.
authors.forename: James B
authors.initials: JB
authors.lastname: Hermiller
authors.affiliation: Department of Cardiovascular Surgery, Mount Sinai Health System, New York, NY.
authors.forename: Stan
authors.initials: S
authors.lastname: Chetcuti
authors.affiliation: Department of Cardiovascular Surgery, Pinnacle Health, Harrisburg, Pa.
authors.forename: Mubashir
authors.initials: M
authors.lastname: Mumtaz
authors.affiliation: Interventional Cardiology, Riverside Methodist Hospital, Columbus, Ohio.
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Yakubov
authors.affiliation: Department of Cardiothoracic Surgery, Houston Methodist DeBakey Heart & Vascular Center, Houston, Tex.
authors.forename: Neal S
authors.initials: NS
authors.lastname: Kleiman
authors.affiliation: Biostatistical Services, Medtronic, Minneapolis, Minn.
authors.forename: Jian
authors.initials: J
authors.lastname: Huang
authors.affiliation: Department of Cardiothoracic Surgery, Houston Methodist DeBakey Heart & Vascular Center, Houston, Tex.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Reardon
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000818:Animals; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D002423:Cause of Death; D015897:Comorbidity; D005260:Female; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000401:mortality*; D006801:Humans; D008297:Male; D015337:Multicenter Studies as Topic / Q000379:methods*; D011183:Postoperative Complications / Q000401:mortality; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D034421:Sus scrofa; D013997:Time Factors; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects / Q000401:mortality*; D016896:Treatment Outcome; D014481:United States
keywords: aortic stenosis; causes of death; surgical aortic valve replacement; transcatheter aortic valve replacement