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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. CONCLUSION: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.

journal_name

Heart Rhythm

journal_title

Heart rhythm

authors

Lakkireddy D,Pillarisetti J,Atkins D,Biria M,Reddy M,Murray C,Bommana S,Shanberg D,Adabala N,Pimentel R,Dendi R,Emert M,Vacek J,Dawn B,Berenbom L

doi

10.1016/j.hrthm.2015.01.035

subject

Has Abstract

pub_date

2015-05-01 00:00:00

pages

950-6

issue

eissn

1547-5271

issn

1556-3871

pii

S1547-5271(15)00134-4

journal_volume

pub_type

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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.