Novel compression device helps prevent haematomas after CIED placement

The use of a novel compression device helps reduce the incidence of pocket haematomas and skin erosions in patients undergoing cardiovascular electronic implantable device (CIED) implantation, according to a recent study.

Through this device, “the length of hospital stay and re-operation rate can be decreased, and patient comfort can be improved,” the researchers said. “Further large, multicentre studies should be performed to validate the effectiveness of the novel compression device in this population.”

A total of 204 participants who were on continuous direct oral anticoagulant (DOAC) medication and scheduled for CIED implantation participated in the study. Patients were randomized to receive either the novel compression device (experimental group; n=102) or an elastic adhesive tape with a sandbag (control group; n=102).

After the CIED procedures, the primary outcome of pocket haematoma was three times more common in the control vs experimental group, a difference that reached statistical significance (36.3 percent vs 11.8 percent; p<0.01). [Front Cardiovasc Med 2022;doi:10.3389/fcvm.2022.817453]

Further stratifying according to haematoma grade showed that using the compression device led to superior outcomes, with significantly lower rates of grade 1 (7.8 percent vs 23.5 percent; p<0.01), grade 2 (2.0 percent vs 5.9 percent; p<0.01), and grade 3 (2.0 percent vs 6.8 percent; p=0.03) haematomas in the experimental arm.

Analysis stratified according to the type of CIED implant likewise revealed that the compression device led to a lower rate of grade 3 haematoma in patients who had received defibrillator cardiac resynchronization therapy (1.0 percent vs 3.9 percent; p<0.01).

Similar patterns emerged for pacemakers and implantable cardiovert defibrillators, but owing to the very low number of cases in both groups, statistical significance could not be proven.

Multivariable analysis adjusted for potential confounders confirmed that using the novel compression device was significantly protective, suppressing the odds of pocket haematoma by nearly 60 percent (odds ratio, 0.42, 95 percent confidence interval [CI], 0.29–0.69; p=0.01).

The compression device also trumped the adhesive control in terms of secondary outcomes. There were no cases of skin erosions in the experimental group, while it occurred in 8.8 percent of controls (p<0.01). Mean patient comfort scores were also superior in compression device users (7.2 vs 4.8; p<0.01).

“The proposed novel pocket compression device has several advantages over the use of elastic adhesive tape and sandbags,” the researchers said. “First, the specially designed shoulder band and chest band can certainly fix the device over the pocket and sustain the pressure on it when patients change their body position.”

The second, they added, was that the device had a knob-and-screw system to manually adjust its tightness, allowing the compression band to apply appropriate pressure to the pocket while still maximizing patient comfort. More sophisticated pressure-adjustment mechanisms could be the subject of future development.

“Third, the proposed device is made of cotton fabric and medical silica gel, so it unlikely causes skin erosion, which is especially considerable for the elderly who have sensitive and delicate skin,” the researchers said.