Key result
POCKET trial protocol outlines randomized comparison of intramuscular versus subcutaneous pacemaker placement.
Why the study?
Does intramuscular placement improve patient overall satisfaction with the pocket location at 24 months compared to subcutaneous placement in patients receiving a de novo bradycardia pacemaker?
RCT (n=200)
Single-blind (patient and subsequent care blinded)
Permutated blocks with random block sizes, stratified by age and sex
No
Does intramuscular placement improve patient overall satisfaction with the pocket location at 24 months compared to subcutaneous placement in patients receiving a de novo bradycardia pacemaker?
Answers are grounded in this paper and cite their sources.
The POCKET trial is designed to determine if intramuscular placement of a bradycardia pacemaker improves patient satisfaction and reduces pocket-related complications compared to standard subcutaneous placement.
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.
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Magnusson et al. (2017) conducted an RCT in Indication for bradycardia pacemaker implantation (n=200). Intramuscular placement of pacemaker pocket vs. Subcutaneous placement of pacemaker pocket was evaluated on Patient overall satisfaction with the pocket location at 24 months as measured using a visual analog scale (VAS) 0-10. The POCKET trial is a study protocol designed to compare intramuscular versus subcutaneous placement of a bradycardia pacemaker, and does not yet report clinical results.
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