{"id":11255,"date":"2025-01-22T11:25:05","date_gmt":"2025-01-22T10:25:05","guid":{"rendered":"https:\/\/sygeplejevidenskab.dk\/?p=11255"},"modified":"2025-09-02T17:03:40","modified_gmt":"2025-09-02T15:03:40","slug":"compression-after-device-implantation-results-from-a-quasi-experimental-cadi-study","status":"publish","type":"post","link":"https:\/\/sygeplejevidenskab.dk\/index.php\/2025\/01\/22\/compression-after-device-implantation-results-from-a-quasi-experimental-cadi-study\/","title":{"rendered":"Compression after Device Implantation: Results from a Quasi-experimental CADI-Study"},"content":{"rendered":"

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Cecilie Fuglsbjerg RN, MSc<\/span>1*<\/strong><\/span>, Berit Thornvig Philbert MD, phD1<\/strong><\/span> , Lau Caspar Thygesen, Professor MSc, PhD3<\/strong><\/span> <\/span>Michael Vinther MD1<\/strong><\/span>, <\/span>Niels Risum MD, PhD1<\/strong><\/span>,<\/span> Signe Westh Christensen Msc1<\/strong><\/span>, Signe Stelling Risom RN, MSc, PhD 1,2,4,5<\/strong> <\/span><\/p>\n

1 <\/span><\/strong>The Heart Centre, Copenhagen University Hospital, Rigshospitalet, Denmark
\n<\/span>2<\/span><\/strong> Institute of Health and Medical Sciences, Copenhagen University, Denmark
\n<\/span>3<\/span><\/strong> National Institute of Public Health, University of Southern Denmark
\n<\/span>4 <\/span><\/strong>Institute of nursing and nutrition, University College Copenhagen, Denmark
\n<\/span>5 <\/span><\/strong>Department of Cardiology, Herlev and Gentofte University Hospital, Denmark
\n<\/span>*<\/span><\/strong>Corresponding author: cecilie.fuglsbjerg@regionh.dk<\/span><\/p>\n

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Abstract
\n<\/span><\/strong>Aim
\n<\/span><\/strong>To investigate whether a compressive dressing after pacemaker or implantable cardioverter defibrillator (ICD) implantation and replacement applied for three hours can prevent bleeding, hematomas and pain.
\n<\/span>Method
\n<\/span><\/strong>The study was a quasi-experimental interventional study including patients scheduled for implantation or replacement of a pacemaker or an ICD. In alternating months patients either received a compressive dressing (intervention group) or no compressive dressing (control group). Patients were followed at the catheterization lab, for three hours on the ward and until the first outpatient control visit (after 1-3 months). Outcomes was:<\/span> Bleeding graded as bleeding, oozing or pocket-hematomas. Hematomas were measured by degrees and size. Pain was rated in a numerical rank scale (NRS).
\n<\/span>Results
\n<\/span><\/strong>A total of 242 elective patients were included (intervention group n=114, control group n=128). The intervention group did not show any significant difference in development of pocket-hematomas compared to the control (p=0.24). Pain score was low in both groups (intervention NRS=1.41 vs. control NRS 1.32). Furthermore, no significant difference in pocket hematomas at follow-up were observed (p=0.77).
\n<\/span>Conclusion
\n<\/span><\/strong>Using a compressive dressing did not significantly reduce bleeding or pocket hematomas after pacemaker or ICD implantation or replacement. Furthermore, no significant difference related to pain was observed. This study shows that patients who are not considered to be at elevated risk for bleeding or pocket-hematomas do not seem to benefit from a compressive dressing.
\n<\/span>Keywords
\n<\/span><\/strong>Pacemaker, Implantable Cardioverter Defibrillator, Prophylactic compression bandaging, Pocket-hematoma, Device, Compression tool.<\/span><\/p>\n<\/div>\n

Introduction
\n<\/span><\/strong>Cardiovascular implantable electronic devices (CIED) such as a pacemaker (PM) or Implantable cardioverter defibrillator (ICD) are implanted in patients worldwide in increasing numbers and have become the standard management of cardiovascular conditions like bradyarrhythmia, primary and secondary prevention of sudden cardiac death and cardiac resynchronization therapy in patients with congestive heart failure (1). <\/span>When implanting a CIED, a pocket is created, most often subcutaneous in the upper chest. Development of a pocket-hematoma is a known complication after an implantation\/replacement, particularly in patients receiving perioperative anticoagulation(2, 3).<\/span><\/p>\n

Medical treatment like anticoagulation is associated with increased bleeding (2) Other factors associated with the development of pocket-hematoma are chronic kidney disease (4) and Body Mass Index (BMI)(5). A study has found that a BMI score under 23 is associated with increased risk of bleeding and a higher BMI is associated with lower risk of bleeding (6).The incidence of pocket hematomas is estimated at 2.3% to 7.3% (5, 7). <\/span>The development of pocket hematomas can evolve into a serious condition for the patient since it is associated with localized pain and increased infection risk which can result in a reoperation, prolonged hospital stay, increased healthcare-related costs and unfavorable outcomes for the patient(8).<\/span><\/p>\n

To prevent pocket-hematomas different pressure dressings have been tested in smaller trials but the results are not consistent (9-11). <\/span>One study tested a new compression tool consisting of a gel-filled pouch to compress the pocket compared with a conventional pressure dressing. They included 46 patients and found that the new tool provided adequate pressure and that it may prevent pocket hematomas and skin erosions, but highlighted that larger randomized studies are needed (11).<\/span><\/p>\n

The primary aim of this study was to see whether a compressive dressing applied for three hours after implantation or replacement of a CIED could prevent pocket hematomas. <\/span>The secondary aim was to see whether a compressive dressing applied for three hours could prevent bleeding, pain, and skin lesions.<\/span><\/p>\n

Methods
\n<\/span><\/strong>The study was submitted to the local ethics committee and approval was not required (Journal number: H-19014229). The study was approved by the Danish Data Protection Agency (reg. nr. VD-2019-159) and complied with the Declaration of Helsinki (12. Trained catheteri-zation laboratory (cath. lab.) nurses provided the patient with oral and written information about the study while hospitalized, but before the PM or ICD procedure, and the patients signed an informed consent declaration before the procedure.<\/span><\/p>\n

Participants, setting, and recruitment
\n<\/span><\/strong>Consecutive patients hospitalized at the day-unit or the arrhythmia department at a large urban university hospital, planned for an elective procedure: Either a new implant or replacement of a PM or ICD were screened for inclusion. Patients \u226518 years of age, and who could provide oral and written informed consent were eligible for participation. Patients that did not understand Danish or were not able to cooperate were excluded. <\/span>The patients were recruited in relation to their planned admission from the 1st of May 2019 to 31st of December 2019. All patients followed the local instructions for pausing blood-thinning treatment and, according to the protocol, patients received 1000 mg of paracetamol before the procedure (13, 14).<\/span><\/p>\n

Quasi-experimental design
\n<\/span><\/strong>Patients were assigned by month at enrollment. The assignment meant that all patients included in the first month were allocated to the control group, patients included in the second month were allocated to the intervention group and so on for a total 8 months. <\/span>Each month\u2019s oral and written information was distributed to health personnel concerning the change in compressive dressing practice. It was not possible to blind the patients or personnel because of the size and placement of the compressive dressing.<\/span><\/p>\n

Intervention group
\n<\/span><\/strong>The intervention consisted of a compressive dressing that was made of two surgical napkins rolled up and placed over the sutured incision by the nurse after the end of the PM or ICD procedure.
\nThen, two long pieces of Mefix\u00ae tape were applied tightly from the patient\u2019s upper back and upper arm down the patient’s chest so that the two napkins compressed into the surgical field, see<\/strong><\/span> Photo 1<\/span><\/strong>.
\n<\/span>Control group
\n<\/span><\/strong>For patients in the control group a compression dressing was not applied, see<\/strong><\/span> Photo 2<\/span><\/strong>.<\/span><\/p>\n

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Outcome evaluation
\n<\/span><\/strong>Pre-planned outcome assessments were collected at the Cardiac Catheterization Laboratory right after the procedure, after three hours on the ward and at the first outpatient control visit 1-3 months after the procedure.<\/span><\/p>\n

The primary outcome
\n<\/span><\/strong>Pocket hematomas three hours after the procedure. The size of the hematoma (length and width) was measured in centimeters, and hematomas were measured by(3):<\/span><\/p>\n