The Premofix compression system was associated with a similar rate of hematoma grade >1 or pocket infection compared to the SafeGuard system after CIED implantation (5.9% vs 4.9%; p=1).
Cohort (n=204)
Does the Premofix compression system reduce the composite of hematoma grade > 1 and/or pocket infection compared to the SafeGuard Focus compression system in patients on anticoagulation or DAPT undergoing CIED implantation?
In patients on anticoagulation or DAPT undergoing CIED implantation, the Premofix and SafeGuard Focus compression devices demonstrated comparable safety and effectiveness profiles for preventing pocket complications.
Absolute Event Rate: 5.9% vs 4.9%
p-value: p=1
Abstract Background Implantation of cardiac implantable electronic devices (CIEDs) in patients on anticoagulation and/or dual antiplatelet therapy (DAPT) poses a risk for complications such as hematomas and infections. Such complications lead to a decrease of patient’s health and increase of cost. Purpose We sought to assess the safety and effectiveness of the Premofix compression bandage system and the SafeGuard Focus™ compression system after CIED implantation in patients receiving anticoagulation and/or dual antiplatelet therapy (DAPT). Methods We retrospectively enrolled all consecutive patients admitted for first permanent CIED implantation receiving anticoagulation and/or dual antiplatelet therapy (DAPT). From January 1 through June 31, 2024, all patients received the Premofix compression system; thereafter, from July 1 through December 31, all patients received the SafeGuard system postoperatively. The primary endpoint (1° EP) was a composite of hematoma grade 1 and/or pocket infection. Results We included 204 patients (median age 75 years; 70% male). Among them 116 (56.8%) received oral anticoagulation, 49 (24.0%) were on DAPT, 16 (7.8%) received Heparin, 6 (2.9%) were on DAT and 17 (8.3%) received both (triple therapy). The occurrence of the 1° EP was similar in both groups (5.9% versus 4.9%; p=1). Hematomas requiring evacuation were rare (1.0% in both groups), Grade 3 hematoma and hematomas prolonging hospitalization were numerically more frequent observed in the SafeGuard group without reaching statistical significance. Hematoma grade 2 or 3 was more comm on in patients with INR values 2.5 (14.3%) and those on triple therapy (25.0%). Pocket-related hematomas were more frequent in defibrillator/CRT-D recipients compared to pacemaker/CRT-P recipients (8.2% vs. 3.9% for Premofix; 13.6% vs. 2.5% for SafeGuard). See Table 1. Conclusions in patients receiving anticoagulation and/or DAPT undergoing CIED implantation, the use of Premofix or Safeguard Focus compression devices were associated with a comparable safety and effectiveness profile.
Dali et al. (Sat,) conducted a cohort in Cardiac implantable electronic device (CIED) implantation on anticoagulation or DAPT (n=204). Premofix compression system vs. SafeGuard Focus compression system was evaluated on Composite of hematoma grade > 1 and/or pocket infection (p=1). The Premofix compression system was associated with a similar rate of hematoma grade >1 or pocket infection compared to the SafeGuard system after CIED implantation (5.9% vs 4.9%; p=1).