title: Quality of life assessment in the randomized PROTECT AF (Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation) trial of patients at risk for stroke with nonvalvular atrial fibrillation.
abstract: OBJECTIVE
  This study sought to assess quality of life parameters in a subset of patients enrolled in the PROTECT AF (Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation) trial.
  
  
  BACKGROUND
  The PROTECT AF (Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation) trial demonstrated that in patients with nonvalvular atrial fibrillation (AF) and CHADS2 (congestive heart failure, hypertension, age, diabetes mellitus, and prior stroke, transient ischemic attack, or thromboembolism) score ≥1, a left atrial appendage closure device is noninferior to long-term warfarin for stroke prevention. Given this equivalency, quality of life (QOL) indicators are an important metric for evaluating these 2 different strategies.
  
  
  METHODS
  QOL using the Short-Form 12 Health Survey, version 2, measurement tool was obtained at baseline and 12 months in a subset of 547 patients in the PROTECT AF trial (361 device and 186 warfarin patients). The analysis cohort consisted of patients for whom either paired quality of life data were available after 12 months of follow-up or for patients who died.
  
  
  RESULTS
  With the device, the total physical score improved in 34.9% and was unchanged in 29.9% versus warfarin in whom 24.7% were improved and 31.7% were unchanged (p = 0.01). Mental health improvement occurred in 33.0% of the device group versus 22.6% in the warfarin group (p = 0.06). There was a significant improvement in QOL in patients randomized to device for total physical score, physical function, and in physical role limitation compared to control. There were significant differences in the change in total physical score among warfarin naive and not-warfarin naive subgroups in the device group compared to control, but larger gains were seen with the warfarin naive subgroup with a 12-month change of 1.3 ± 8.8 versus -3.6 ± 6.7 (p = 0.0004) device compared to warfarin.
  
  
  CONCLUSIONS
  Patients with nonvalvular AF at risk for stroke treated with left atrial appendage closure have favorable QOL changes at 12 months versus patients treated with warfarin. (WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation [WATCHMAN PROTECT]; NCT00129545).
authors.affiliation: University of Alabama, Birmingham, Alabama, USA.
authors.forename: Oluseun
authors.initials: O
authors.lastname: Alli
authors.forename: Shepal
authors.initials: S
authors.lastname: Doshi
authors.forename: Saibal
authors.initials: S
authors.lastname: Kar
authors.forename: Vivek
authors.initials: V
authors.lastname: Reddy
authors.forename: Horst
authors.initials: H
authors.lastname: Sievert
authors.forename: Chris
authors.initials: C
authors.lastname: Mullin
authors.forename: Vijay
authors.initials: V
authors.lastname: Swarup
authors.forename: Brian
authors.initials: B
authors.lastname: Whisenant
authors.forename: David
authors.initials: D
authors.lastname: Holmes
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000627:therapeutic use; D020517:Atrial Appendage / Q000473:pathology / Q000601:surgery; D001281:Atrial Fibrillation / Q000188:drug therapy* / Q000208:ethnology / Q000523:psychology / Q000601:surgery*; D003251:Constriction, Pathologic / Q000601:surgery; D005260:Female; D005500:Follow-Up Studies; D006304:Health Status; D006801:Humans; D008297:Male; D008875:Middle Aged; D011322:Primary Prevention / Q000379:methods; D011446:Prospective Studies; D011788:Quality of Life; D020521:Stroke / Q000209:etiology / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome; D014859:Warfarin / Q000627:therapeutic use
chemical_list: D000925:Anticoagulants; D014859:Warfarin