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It is with pride and gratitude that we reflect on the remarkable 10-year journey of European Journal of Arrhythmia & Electrophysiology. With the vital contributions of all of our esteemed authors, reviewers and editorial board members, the journal has served as a platform for groundbreaking research, clinical insights and news that have helped shape the […]

Placement Of Cardiac PacemaKEr Trial (POCKET) – rationale and design: a randomized controlled trial

Peter Magnusson, Leo Wennström, Robert Kastberg, Per Liv
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Published Online: Aug 22nd 2018 Heart International. 2017;12(1):e8-e11 DOI: https://doi.org/10.5301/heartint.5000235
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Abstract

Overview

Background.
A pacemaker system consists of one or two leads connected to a device that is implanted into a
pocket formed just below the collarbone. This pocket is typically subcutaneous, that is, located just above the
pectoral fascia. Even though the size of pacemakers has decreased markedly, complications due to superficial implants do occur. An alternative technique would be intramuscular placement of the pacemaker device, but there
are no randomized controlled trials (RCTs) to support this approach, which is the rationale for the Placement Of
Cardiac PacemaKEr Trial (POCKET). The aim is to study if intramuscular is superior to subcutaneous placement of
a pacemaker pocket.
Methods.
In October 2016, we started to enroll 200 consecutive patients with an indication for bradycardia pacemaker implantation. Patients are randomized to random block sizes, stratified by age group (cut-off: 65 years)
and sex, and then randomized to either subcutaneous or intramuscular implant. A concealed allocation procedure is employed, using sequentially numbered, sealed envelopes. Pocket site is blinded to the patient and in all
subsequent care. The primary endpoint is patient overall satisfaction with the pocket location at 24 months as
measured using a visual analog scale (VAS) 0-10. Secondary endpoints are: complications, patient-reported satisfaction at 1, 12, and 24 months (overall satisfaction, pain, discomfort, degree of unsightly appearance, movement
problems, and sleep problems due to device).
Conclusions.
POCKET is a prospective interventional RCT designed to evaluate if intramuscular is superior to subcutaneous placement of a bradycardia pacemaker during a two-year follow-up.

Keywords

Arrhythmia, Complication, Pacemaker, Pocket, Randomized controlled trial

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Article Information

Disclosure

Financial support: Region Gävleborg funded this research project.

Correspondence

Peter Magnusson Cardiology Research Unit Department of Medicine Karolinska Institutet Karolinska University Hospital/Solna SE-171 76 Stockholm, Sweden peter.magnusson@regiongavleborg.se

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