TY - JOUR
T1 - 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)
T2 - A prospective randomized study
AU - Lakkireddy, Dhanunjaya
AU - Pillarisetti, Jayasree
AU - Atkins, Donita
AU - Biria, Mazda
AU - Reddy, Madhu
AU - Murray, Caroline
AU - Bommana, Sudharani
AU - Shanberg, David
AU - Adabala, Nivedita
AU - Pimentel, Rhea
AU - Dendi, Raghuveer
AU - Emert, Martin
AU - Vacek, James
AU - Dawn, Buddhadeb
AU - Berenbom, Loren
N1 - Publisher Copyright:
© 2015 Heart Rhythm Society. All rights reserved.
PY - 2015/5/1
Y1 - 2015/5/1
N2 - 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.
AB - 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.
KW - Cardiac device infection
KW - Endocarditis
KW - Fibrous capsule
KW - Mortality
KW - Pocket revision
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U2 - 10.1016/j.hrthm.2015.01.035
DO - 10.1016/j.hrthm.2015.01.035
M3 - Article
C2 - 25625720
AN - SCOPUS:84928614149
SN - 1547-5271
VL - 12
SP - 950
EP - 956
JO - Heart Rhythm
JF - Heart Rhythm
IS - 5
M1 - 6106
ER -