title: One-Year Outcomes of Transcatheter Aortic Valve Replacement in Patients With End-Stage Renal Disease.
abstract: BACKGROUND
  End-stage renal disease (ESRD) poses unique challenges in the treatment of patients with severe aortic stenosis. Although surgical valve replacement in ESRD patients has been associated with increased mortality, the outcomes from transcatheter aortic valve replacement (TAVR) are not clearly defined.
  
  
  METHODS
  The CoreValve US Expanded Use Study is a prospective, nonrandomized study of TAVR in extreme-risk patients with comorbidities excluding them from the Pivotal Trial. We report on patients with ESRD. The primary endpoint was a composite of all-cause mortality or major stroke at 1 year.
  
  
  RESULTS
  Ninety-six patients with ESRD underwent TAVR with the CoreValve (Medtronic, Minneapolis, MN) and have reached 1-year follow-up. Mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 16.2% ± 8.4%. The rate of all-cause mortality or major stroke at 1 year was 30.3%. The all-cause mortality rate was 5.3% at 30 days and 30.3% at 1 year. The rate at 1 year of any stroke or transient ischemic attack was 2.1%; major vascular injury was 5.2%; and new permanent pacemaker was 26.8%. Valve performance improved postprocedure and remained improved at 1 year (effective orifice area 1.71 cm2, mean gradient 9.33 mm Hg) CONCLUSIONS: Early mortality in patients with ESRD is comparable to previously published data on extreme-risk patients without ESRD, but our data suggest a higher mortality rate at 1 year for ESRD patients, likely due to comorbid conditions. Stroke and major vascular injury are infrequent, and improved valve hemodynamics are maintained at 1 year.
authors.affiliation: Department of Cardiothoracic Surgery, Aurora Healthcare, Milwaukee, Wisconsin. Electronic address: daniel.o'hair@aurora.org.
authors.forename: Daniel P
authors.initials: DP
authors.lastname: O'Hair
authors.affiliation: Department of Cardiology, Aurora Healthcare, Milwaukee, Wisconsin.
authors.forename: Tanvir K
authors.initials: TK
authors.lastname: Bajwa
authors.affiliation: Department of Cardiology, University of Michigan, Ann Arbor, Michigan.
authors.forename: Stanley J
authors.initials: SJ
authors.lastname: Chetcuti
authors.affiliation: Department of Surgery, University of Michigan, Ann Arbor, Michigan.
authors.forename: G Michael
authors.initials: GM
authors.lastname: Deeb
authors.affiliation: Department of Cardiology, Baylor Heart and Vascular Hospital, Houston, Texas.
authors.forename: Robert C
authors.initials: RC
authors.lastname: Stoler
authors.affiliation: Department of Cardiothoracic Surgery, Baylor Heart and Vascular Hospital, Houston, Texas.
authors.forename: Robert F
authors.initials: RF
authors.lastname: Hebeler
authors.affiliation: Department of Cardiology, Tenet Healthcare, Delray Beach, Florida.
authors.forename: Brijeshwar
authors.initials: B
authors.lastname: Maini
authors.affiliation: Department of Cardiothoracic Surgery, Pinnacle Health, Harrisburg, Pennsylvania.
authors.forename: Mubashir
authors.initials: M
authors.lastname: Mumtaz
authors.affiliation: Department of Cardiology, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas.
authors.forename: Neal S
authors.initials: NS
authors.lastname: Kleiman
authors.affiliation: Department of Cardiac Surgery, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Reardon
authors.affiliation: Department of Biostatistics, Medtronic, Minneapolis, Minnesota.
authors.forename: Shuzhen
authors.initials: S
authors.lastname: Li
authors.affiliation: Department of Cardiovascular Surgery, Mount Sinai Medical Center, New York, New York.
authors.forename: David H
authors.initials: DH
authors.lastname: Adams
authors.affiliation: Department of Cardiothoracic Surgery, Riverside Methodist Hospital, Columbus, Ohio.
authors.forename: Daniel R
authors.initials: DR
authors.lastname: Watson
authors.affiliation: Department of Cardiology, Riverside Methodist Hospital, Columbus, Ohio.
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Yakubov
authors.affiliation: Department of Internal Medicine, Cardiovascular Division, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Popma
authors.affiliation: Department of Cardiology, St. Francis Hospital, Roslyn, New York.
authors.forename: George
authors.initials: G
authors.lastname: Petrossian
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000401:mortality* / Q000601:surgery*; D002423:Cause of Death; D015897:Comorbidity; D004452:Echocardiography; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D007676:Kidney Failure, Chronic / Q000150:complications* / Q000000981:diagnostic imaging; D008297:Male; D011183:Postoperative Complications / Q000000981:diagnostic imaging / Q000401:mortality*; D011446:Prospective Studies; D017582:Renal Replacement Therapy; D012307:Risk Factors; D015996:Survival Rate; D065467:Transcatheter Aortic Valve Replacement / Q000379:methods* / Q000401:mortality*