title: IMpact of pocKet rEvision on the rate of InfecTion and other CompLications in patients rEquiring pocket mAnipulation for generator replacement and/or lead replacement or revisioN (MAKE IT CLEAN): A prospective randomized study.
abstract: BACKGROUND
  The fibrous capsule around cardiac implantable device generators is known to promote bacterial colonization and latent infection. Removal of the capsule during device replacement procedures may reduce infection rates but may increase hemorrhagic complications.
  
  
  OBJECTIVE
  The purpose of this study was to evaluate the effect of pocket capsule decortication procedure on infection and bleeding rates in patients undergoing device replacement procedures.
  
  
  METHODS
  In a prospective randomized single-blind control study, patients undergoing device replacement, upgrade, or lead extraction were randomized to Group A "with pocket revision" (n = 131) and group B "without pocket revision" (n = 127). Deep and superficial infection rates, bleeding, and prolonged serous drainage were assessed during 12 months of follow-up. Data were analyzed according to intention-to-treat principle.
  
  
  RESULTS
  A total of 258 patients were enrolled in the study. Rates of generator change, upgrade, and lead extraction/replacement were similar between both groups. There was no incidence of deep infection in either group at 12-month follow-up. There was no significant difference in the incidence of superficial infection between groups (1.5% vs 4.7%, P = .13) during 12-month follow-up. There was a significant increase in acute hematoma formation in group A compared to group B (6.1% vs 0.8%, P = .03). Two patients in group A had to undergo hematoma evacuation.
  
  
  CONCLUSIONS
  There was increased incidence of hematoma formation in group A with no effect on infection rates. Our study suggests that there is no benefit to performing empiric pocket revision.
authors.affiliation: Division of Cardiology, University of Kansas Hospital, Kansa City, Kansas. Electronic address: dlakkireddy@gmail.com.
authors.forename: Dhanunjaya
authors.initials: D
authors.lastname: Lakkireddy
authors.affiliation: Division of Cardiology, University of Kansas Hospital, Kansa City, Kansas.
authors.forename: Jayasree
authors.initials: J
authors.lastname: Pillarisetti
authors.affiliation: Division of Cardiology, University of Kansas Hospital, Kansa City, Kansas.
authors.forename: Donita
authors.initials: D
authors.lastname: Atkins
authors.affiliation: Division of Cardiology, University of Kansas Hospital, Kansa City, Kansas.
authors.forename: Mazda
authors.initials: M
authors.lastname: Biria
authors.affiliation: Division of Cardiology, University of Kansas Hospital, Kansa City, Kansas.
authors.forename: Madhu
authors.initials: M
authors.lastname: Reddy
authors.affiliation: Division of Cardiology, University of Kansas Hospital, Kansa City, Kansas.
authors.forename: Caroline
authors.initials: C
authors.lastname: Murray
authors.affiliation: Division of Cardiology, University of Kansas Hospital, Kansa City, Kansas.
authors.forename: Sudharani
authors.initials: S
authors.lastname: Bommana
authors.affiliation: Division of Cardiology, University of Kansas Hospital, Kansa City, Kansas.
authors.forename: David
authors.initials: D
authors.lastname: Shanberg
authors.affiliation: Division of Cardiology, University of Kansas Hospital, Kansa City, Kansas.
authors.forename: Nivedita
authors.initials: N
authors.lastname: Adabala
authors.affiliation: Division of Cardiology, University of Kansas Hospital, Kansa City, Kansas.
authors.forename: Rhea
authors.initials: R
authors.lastname: Pimentel
authors.affiliation: Division of Cardiology, University of Kansas Hospital, Kansa City, Kansas.
authors.forename: Raghuveer
authors.initials: R
authors.lastname: Dendi
authors.affiliation: Division of Cardiology, University of Kansas Hospital, Kansa City, Kansas.
authors.forename: Martin
authors.initials: M
authors.lastname: Emert
authors.affiliation: Division of Cardiology, University of Kansas Hospital, Kansa City, Kansas.
authors.forename: James
authors.initials: J
authors.lastname: Vacek
authors.affiliation: Division of Cardiology, University of Kansas Hospital, Kansa City, Kansas.
authors.forename: Buddhadeb
authors.initials: B
authors.lastname: Dawn
authors.affiliation: Division of Cardiology, University of Kansas Hospital, Kansa City, Kansas.
authors.forename: Loren
authors.initials: L
authors.lastname: Berenbom
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D020878:Device Removal / Q000009:adverse effects / Q000379:methods; D004322:Drainage / Q000379:methods; D004567:Electrodes, Implanted / Q000009:adverse effects*; D005260:Female; D005500:Follow-Up Studies; D006331:Heart Diseases / Q000601:surgery*; D006801:Humans; D057910:Implant Capsular Contracture / Q000209:etiology / Q000601:surgery; D015994:Incidence; D007615:Kansas; D008297:Male; D008875:Middle Aged; D019106:Postoperative Hemorrhage / Q000453:epidemiology / Q000209:etiology / Q000601:surgery; D019919:Prosthesis Implantation / Q000009:adverse effects* / Q000379:methods; D016459:Prosthesis-Related Infections / Q000209:etiology / Q000628:therapy; D012086:Reoperation / Q000009:adverse effects / Q000379:methods; D018570:Risk Assessment; D012307:Risk Factors; D016037:Single-Blind Method; D016896:Treatment Outcome
keywords: Cardiac device infection; Endocarditis; Fibrous capsule; Mortality; Pocket revision