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

Lakkireddy, Dhanunjaya; Pillarisetti, Jayasree; Atkins, Donita; Biria, Mazda; Reddy, Madhu; Murray, Caroline; Bommana, Sudharani; Shanberg, David; Adabala, Nivedita; Pimentel, Rhea; Dendi, Raghuveer; Emert, Martin; Vacek, James L.; Dawn, Buddhadeb; Berenbom, Loren

doi:10.1016/j.hrthm.2015.01.035

Cited by 35 publications

(22 citation statements)

References 33 publications

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“…A recently published study however reported no difference in infectious complications (1.5% vs. 4.7%, p=0.13) associated with routine pocket revision, despite a significant increase in hematoma formation (6.1% vs. 0.8%, p=0.03). 82 The trial was however relatively small (n=258). Another prospective trial addressing the merits of routine capsulectomy is currently underway.…”

Section: Operative Considerationsmentioning

confidence: 99%

Preventing cardiac implantable electronic device infections

Padfield¹,

Steinberg²,

Bennett³

et al. 2015

Heart Rhythm

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Section: Operative Considerationsmentioning

confidence: 99%

Preventing cardiac implantable electronic device infections

Padfield¹,

Steinberg²,

Bennett³

et al. 2015

Heart Rhythm

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“…Data shows that use of temporary pacing prior to the implantation procedure 4, an early pocket reexploration [ 51 ], the presence of more than two pacing leads [ 42 , 54 ], and the implantation of a defibrillator more than a pacemaker [ 55 ] are some of the procedural characteristics associated with a higher infection rate. Procedures done for the revision of CIED have had contradictory reports as being a risk factor for CIED related infections [ 10 – 12 ]. However, an antibacterial envelope for CIED implantation has been suggested to be protective against CIED infection especially in high risk patients in a small retrospective industry sponsored trial [ 51 ] as stated in the prior section.…”

Section: Infection Prevention Measuresmentioning

confidence: 99%

“…Also, other risk factors related to the procedure itself such as the implantation of multiple leads versus a single lead, an emergency versus an elective procedure, inpatient versus outpatient procedure, and longer versus shorter procedures have been shown to increase the rate of CIED infections. Procedures done for the revision of CIED have had contradictory reports as being a risk factor for CIED related infections [ 10 – 12 ].…”

Section: Introductionmentioning

confidence: 99%

Cardiac Implantable Electronic Device Infection: From an Infection Prevention Perspective

Sastry

Rahman²,

Yassin

2015

Advances in Preventive Medicine

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A cardiac implantable electronic device (CIED) is indicated for patients with severely reduced ejection fraction or with life-threatening cardiac arrhythmias. Infection related to a CIED is one of the most feared complications of this life-saving device. The rate of CIED infection has been estimated to be between 2 and 25; though evidence shows that this rate continues to rise with increasing expenditure to the patient as well as healthcare systems. Multiple risk factors have been attributed to the increased rates of CIED infection and host comorbidities as well as procedure related risks. Infection prevention efforts are being developed as defined bundles in numerous hospitals around the country given the increased morbidity and mortality from CIED related infections. This paper aims at reviewing the various infection prevention measures employed at hospitals and also highlights the areas that have relatively less established evidence for efficacy.

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“…Most operators advocate for a thorough debridement of the pocket with the removal of all infected and fibrotic tissue, including the entire capsule . However, extensive debridement of infected tissue can lead to recurrent postoperative bleeding and the development of a hematoma . There is no consensus in regard to the optimal pocket management strategy during and after the extraction procedure.…”

Section: Introductionmentioning

confidence: 99%

Use of a novel bipolar sealer device in pocket infections: A case series

Schaller

Tomczuk

Frankel

2019

Cardiovasc electrophysiol

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Background Cardiac implantable electronic device pocket infections require complete system removal. However, postoperative bleeding and hematoma can occur after extensive debridement and an optimal management strategy has yet to be defined. Methods Following system removal and debridement, all pockets were treated with the Aquamantys bipolar sealer until hemostasis of the underlying tissue was achieved. Clinical characteristics, sealer application time, and postoperative outcomes were analyzed. Results Thirteen consecutive patients were included with an average age of 61.6 years and 8/13 were male. One patient had both pocket infection and systemic bacteremia. Explanted devices included three pacemakers, nine transvenous implantable cardioverter‐defibrillators (ICD), and one subcutaneous ICD. The average number of leads extracted was 2.08 ± 1.04 with a median lead dwell time of 75 months (range, 1‐265). Pocket tissue culture yielded Streptococcus anginosus (1), Pseudomonas aeruginosa (2), Staphylococcus epidermidis (1), Staphylococcus aureus (1), and no growth (8). Average time using the Aquamantys was 5.6 ± 2.75 minutes per patient. Twelve out of thirteen pockets were closed by primary intention with one pocket packed and left to heal via secondary intention. A Jackson‐Pratt drain was used in three patients and removed within 3 days. There were no hematomas noted during the acute hospitalization or during follow up and all of the wounds healed completely. Conclusions Use of a novel bipolar sealing device in lieu of traditional electrocautery provided rapid and durable hemostasis with the ability to close almost all of the pockets via primary intention.

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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

Cited by 35 publications

References 33 publications

Preventing cardiac implantable electronic device infections

Preventing cardiac implantable electronic device infections

Cardiac Implantable Electronic Device Infection: From an Infection Prevention Perspective

Use of a novel bipolar sealer device in pocket infections: A case series

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