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A Prospective Study of a Novel Pocket Compression Device to Reduce Pocket Hematoma After Cardiac Implantable
M Tijskens1,2,3, K De Schouwer4, M Wolf1
1Department of Cardiology, ZAS Heart Centre Middelheim, Antwerp, Antwerp, Belgium.
Insights
A novel pocket compression device significantly reduced pocket hematomas and pain after cardiovascular implantable electronic device (CIED) implantation compared to standard tape, enhancing patient safety.
Area of Science:
- Cardiology
- Medical Devices
- Surgical Complications
Background:
- Pocket hematoma (PH) is a frequent complication post-cardiovascular implantable electronic device (CIED) implantation, increasing infection risk.
- Current methods like elastic adhesive tape have limitations, including unpredictable pressure and obscured visual assessment.
- A novel pocket compression device aims to improve PH prevention and monitoring.
Purpose of the Study:
- To assess the safety and efficacy of a new pocket compression device.
- To evaluate its performance in patients with high bleeding risk undergoing CIED implantation.
Main Methods:
- A randomized controlled trial compared a pocket compression device (32 patients) with elastic adhesive tape (33 patients).
- The device features an inflatable, transparent compartment for adjustable compression and visual monitoring.
- Primary outcome: incidence of PH; Secondary outcomes: pressure lesions, pain scores, and endocarditis.
Main Results:
- Significantly fewer PH occurred with the compression device (3.1% vs. 60.6%, p < 0.001).
- The device group reported lower pain scores post-application and on the following day.
- No pressure lesions or endocarditis were observed; severe PH requiring hospitalization was limited to the control group.
Conclusions:
- The pocket compression device is effective in reducing PH and postoperative pain after CIED implantation.
- This novel device offers an improved safety profile, particularly in high-risk populations.
- It represents a significant advancement in managing CIED implantation complications.
Background:
Pocket hematoma (PH) is one of the most common complications after cardiovascular implantable electronic device (CIED) implantation resulting in an up to 9 times higher risk for CIED infections. Different preventive strategies have been proposed with mixed results. Current standard of care consists of preventive elastic adhesive tape leaving 2 major disadvantages: unpredictable pressure on the pocket and inability to visually assess the pocket with the bandage applied.
Aim:
To evaluate the safety and effectiveness of a novel pocket compression device in patients undergoing CIED implantation in a high bleeding population.
Material And Methods:
This randomized controlled trial included 32 patients in the study group (pocket compression device) and 33 in the control group (elastic adhesive tape). The studied pocket compression device contains an inflatable and transparent compartment to modify the degree of pocket compression facilitating pocket evaluation. The primary outcome was the incidence of various grades of PH. The secondary outcomes comprised the incidence of pressure lesion, pain score (0-10) and endocarditis during follow-up.
Results:
There were no clinical or procedural differences between groups (age 78.01 ± 9.71, heart failure 53.8%, kidney failure 20.0% and antithrombotic drug therapy 49.2%). There were significantly less pocket hematomas in the study group (1/32 (3.1%) vs 20/33 (60.6%), p < 0.001). Most pocket hematomas were grade I for which watchful waiting was applied (1/32 (3.1%) vs 17/33 (51.6%), p < 0.001). Grade II and grade III PH only occurred in the control group (respectively 1/33 and 2/33) resulting in hospitalization prolongation and longer interruption of antithrombotic drugs > 24 h. Two control patients eventually received the study device to control PH. None underwent reoperation. Pressure lesions did not occur. Patients in the study group had lower pain scores at application (0.75 ± 1.12 vs 1.80 ± 1.38, p = 0.009), after 2 h (0.81 ± 1.36 vs 1.94 ± 1.50, p = 0.002) and the next day (0.38 ± 0.91 vs 1.06 ± 1.634, p = 0.042). None of the patients experienced endocarditis during mean follow-up of 1 year.
Conclusion:
The use of a pocket compression device in patients undergoing CIED implantation in a high bleeding population leads to less PH and postoperative pain in comparison to conventional elastic adhesive tape. This is especially important in an era where safety of device implantations is paramount.
