Local hemostatic drug application for prophylaxis of pacemaker pocket hematoma

BACKGROUND: Prevention of pacemaker pocket hematoma is an urgent problem of modern cardiovascular surgery. A method of prevention of hematomas may be application of local hemostatic agents. One of such means is incomplete silver salt of polyacrylic acid, registered in the Russian Federation as a medical product under the trade name “Hemoblock”. AIM: To evaluate the efficacy and safety of partial silver salt of polyacrylic acid (Hemoblock®) as a hemostatic drug for prophylaxis of pacemaker (PM) pocket hematoma. MATERIALS AND METHODS: The study included 29 patients (18 men) with average age of 72.8 ± 9.8 years and indications for PM implantation. The patients were divided into 2 groups, partial silver salt of polyacrylic acid was used during the PM implantation in group A, 0.9% NaCl solution was used in group B. Anticoagulant therapy was not cancelled. In the postoperative period, patients underwent a daily examination by a surgeon, on the 3th–5th day — an ultrasound of soft tissues in the area of the PM pocket to diagnose hemorrhagic complications. After 1 month, a control examination of the postoperative wound and an assessment of the PM function were performed. RESULTS: In 1 (6.3%) patient in group B, a PM pocket hematoma was found which required drainage in the dressing room and increased the period of hospitalization after surgery to 7 days. Soft tissue imbibition with blood was observed in 9 (56.3%) group B patients. No PM pocket hematomas and imbibition of soft tissues were observed in group A. PM implantation with uninterrupted anticoagulant therapy without the use of hemostatic agents increases the risk of soft tissue imbibition with blood by 2.3 times (p = 0.001, r = 0.605, RR 2.3, 95% CI 1.3–4). Age, gender, body mass index, body surface area, left ventricular ejection fraction, type of anticoagulation therapy, indication for PM implantation, type of PM, and the peculiarities of the operation did not influence the risk of development of PM pocket hematoma or soft tissue imbibition with blood (p > 0.05). CONCLUSION: The use of a partial silver salt of polyacrylic acid (Hemoblock®) can reduce the risk of development of hematomas and soft tissue imbibition with blood in the area of the pacemaker pocket and does not lead to the development of infectious complications and allergic reactions.

Comparison of Electrocautery Platforms for Pulse Generator Replacement Procedures

Introduction: Lead damage can occur during cardiovascular implantable electronic device (CIED) generator replacement procedures, resulting in additional procedures and added costs. PlasmaBlade (PL) and PhotonBlade (PH) are two commercially available insulated electrocautery devices designed to reduce this risk. Objective: This study compared complication rates of PL and PH in CIED generator replacement procedures. Methods: This retrospective study analyzed transvenous CIED generator replacements using PL or PH from 2017-2020. The primary endpoint was lead damage. Secondary endpoints included rate of pocket hematoma, superficial infection, and infections requiring device removal. Results: A total of 209 patients were included for analysis, including 86 procedures (188 leads) using PL and 123 procedures (266 leads) using PH. Lead insulation material consisted of 237 (52.2%) silicone, 66 (14.5%) polyurethane, and 151 (33.3%) copolymer leads, with no significant difference in frequency of insulation materials (p=0.91). The rate of lead damage was low for both PL and PH (0 vs. 0.4%, p=0.59). There was no significant difference in pocket hematoma (1.2% vs. 1.6%, p=0.43), superficial infection (1.2% vs. 0.8%, p=0.49), or infection requiring device removal (1.2% vs. 0%, p=0.41). The mean absolute change in lead impedance from pre- to post-procedure was similar between PL and PH (72.3 ± 126.1 ohms vs. 60.6 ± 72.3 ohms, p=0.10). Conclusions: There was a low rate of complications after CIED replacement procedures, with no significant difference between the PL and PH groups. A majority of leads with silicone insulation material may have contributed to the low rate of lead damage.

A local gentamicin-collagen sponge reduces cardiovascular implantable electronic device infections and pocket hematoma

Background Implantation or replacement of cardiovascular implantable electronic device (CIED) may be associated with complications such as pocket hematoma and infections. Purpose The aim of this study is to determine whether a lyophilized collagen impact impregnated with the aminoglycoside antibiotic gentamicin, applied according to the size of pocket into the surgical wound during implantation or replacement, reduces major CIED infections and pocket hematoma 12 months after the surgical intervention. Methods We conducted a retrospective study including 1189 patients (mean age 77.45±9.83 y.o.), who underwent implantation or replacement of CIED in our center between June 2007 and November 2018. We compared 475 patients treated with the local gentamicin-collage sponge (group I) with 714 patients who did not receive it (group II). The primary endpoints were the reduction of infectious complications and pocket hematoma through 12 months of follow-up post procedure. Results Complications occurred in 127 of 1189 patients (10.68%): 102 of 1189 patients (8.58%) developed pocket hematoma, 20 of 1189 patients (1.68%) infectious events and 5 of 1189 patients (0.42%) both. Specifically, the rate of complications was lower in group I: pocket hematoma 0.63% vs 13.86% (p<0.001), infections 0.21% vs 2.6% (p=0.02), both 0% vs 0.7% (p=0.17). The study also shows a statistically significant major incidence of infectious complications in subjects undergoing implantation or replacement of ICD, compared to subjects undergoing implantation or replacement of PPM (5.59% vs 1.5%; p<0.05%). Regarding the type of intervention and the incidence of complications within the subgroups, was demonstrated a statistically significant reduction in the incidence of infections in de novo implant-group I subgroup compared to de novo implant-group II subgroup (0.5% vs 3.5%; p<0.05); a statistically significant reduction in the incidence of infectious complications was also observed in replacement-group I subgroup (0%) compared to replacement-group II subgroup (0% vs 1.4%; p<0.05). Similar results were demonstrated for the incidence of pocket hematoma, with a statistically significant reduction in de novo implant-group I subgroup compared to de novo implant-group II subgroup (0.5% vs 14.13%; p<0.05) and in replacement-group I subgroup compared to replacement-group II subgroup (1.4% vs 12.5%; p<0.05). The association between therapy and development of hematoma was not statistically significant. The association between comorbidities and infectious complications in both groups was always statistically significant. Conclusion The local gentamicin-collagen sponge is a medical device which can be used in addition to local hemostasis and prophylactic doses of systemic antibiotics, with the aim of reducing infective complications and pocket hematoma after permanent CIED implantation or replacement. Funding Acknowledgement Type of funding source: None

Efficacy of adrenaline-packed dressing for bleeding control in patients undergoing cardiovascular implantable electronic device implantation; A Single-Center study

Background Each year, 1.65 million people around the world are implanted with Cardiac Implantable Electronic Devices [CIEDs], which our center, performed about 300–350 cases per year. These implantation process needs expertise and specializes in preventing the complication. Some complications, such as device-related bleeding complications (DRBCs) and pocket hematoma, especially in those patients receiving oral antithrombotic drugs before the surgery, should be preventable. Based on our observation of cases in the operation room, the wounds which were easily bleed can effectively create hemostasis by using adrenaline-packed dressing. The purpose of this study is to explore if the adrenaline pack dressing could reduce bleeding complications and reduce pocket hematoma in patients undergoing CIED implantation. Purpose To evaluate if adrenaline-packed dressing during CIED implantation can demonstrate a reduction in bleeding complication. Methods This is a single-center double-blind, randomized control study that included most of the patients undergoing CIED implantation in our center from June 2019 to Jan 2020. The patients will be randomized to adrenaline-packed dressing or matched control group. The protocol requires each patient to have a 2-weeks evaluation at the device clinic by two device-clinic staff. If DRBCs are detected, we used a caliper to measure the size in the largest dimension. Our primary outcome is the incidence of DRBCs at 2-weeks. Results There were 165 patients enrolled from June 2019 to Jan 2020. Mean age was 73 (female 52%), 24% on antiplatelet, 36% on anticoagulant. The pocket hematoma and ecchymosis at the 2-week was 15.8% and 15.2%, respectively. The DRBCs at 2-weeks was not significantly different between groups (22.6% vs. 33.3%; p=0.125). However, the next morning hematoma was significantly decreased in the adrenaline-packed dressing group (13.1% vs. 28.4%; p=0.015). The trend of subgroup analysis in the adrenaline pack dressing group was showing a reduction of DRBCs in patients who on anticoagulation therapy. Conclusion The adrenaline pack dressing appears to reduce early pocket hematoma significantly, but at two weeks, most of them were resolved and make no significant difference between groups. Funding Acknowledgement Type of funding source: None

P1187Pocket-Hematoma after cardiac implantable electronic devices surgery: a single centre study

Intro Pocket hematoma is a common complication after pacemaker (PMK) or implantable cardioverter defibrillator (ICD) surgery. In this clinical setting anticoagulant and antiplatelet therapy are associated with an increased risk of hemorrhagic complications, but data are sparse. Purpose We examined the impact of antiplatelet therapy and anticoagulation with vitamin K antagonists (VKA) or heparin on the risk of pocket hematoma. Materials and method: between august 2017 and june 2019, a total of 639 devices were implanted or replaced at our centre. Predictors of hematoma occurrence were determined by multivariate regression analysis. We used a specific definition of pocket hematoma: a) any palpable swelling in the pocket area requiring an unscheduled visit or prolonged hospitalization > 24 h or re-hospitalization for hematoma, b) interruption of antithrombotics, c) reoperation, d) hemoglobin drop > 2 g/dl or blood transfusion. The above criteria were assessed during hospitalization and up to 10 days after discharge. Results: the incidence of pocket hematoma was 7.5%. Among 639 patients (pts) including in the study 33.5% (214 pts) didn’ t take any antithrombotic therapy, 40.2 % (257 pts) were on single antiplatelet therapy (SAPT), 8.8 % (56 pts) were on dual antiplatelet therapy, 11.1 % (71 pts) were on uninterrupted VKA (mean INR 2). Heparin bridging was administered in 6.4% (41 pts). Ejection fraction (43 ±13 %) and hemoglobin value before implantation (12.3 ±2.6 g/dL) in patients who developed hematoma were significantly lower compared with whose without hematoma. Patients with hematoma had a higher prevalence of congestive heart failure, ischemic cardiomyopathy and intake antithrombotic therapy. After adjusting for confounding factors with multivariate logistic regression only the use of dual antiplatelet therapy (OR 5.9 95% CI 1.5-21 p = 0.008) and the bridging with enoxaparin (OR 5.6 95% CI 1.4-22 p = 0.013) increased the risk of pocket hematoma. Single antiplatelet therapy (OR 2.6 95% CI 0.8-8.4 p = ns) and uninterrupted VKA (OR 0.9 95% CI 0.7-11 p = ns) did not increased the risk of pocket hematoma compared to no antithrombotic therapy. Pulse generator change and new device implant/upgrading (OR 1.8 95% CI 0.6-5.2 p = ns) carried the same haemorrhagic risk. Conclusion the use of DAPT or bridging with enoxaparin are highly predictive for the occurrence of perioperative pocket hematoma in patients scheduled for pmk/icd surgery. In contrast, single antiplatelet therapy and uninterrupted VKA did not increase the risk of hematoma.

848Ultrasound-guided axillary vein puncture feasibility for complex cardiac devices implantation

Background The axillary route use for cardiac devices implantation has recently expanded either with fluoroscopy or ultrasounds guidance. Few studies included defibrillators (ICD), cardiac resynchronization therapy (CRT) and upgrade procedures for ultrasound-guided axillary vein puncture (UGVP). Puropose To assess the feasibility/safety of UGVP for complex cardiac devices implantation including CRT/ICD. Methods Consecutive patients eligible for a pacemaker or ICD implantation were included. All procedures were performed by three operators (one experienced and two fellows). Guidewires insertion time (from lidocaïne administration), and complications were systematically studied. A group of patients implanted with alternative techniques was used for comparison (cephalic, subclavian). Results In 176 consecutive patients in whom UGVP was used, a total of 68 complex procedures were analyzed (74 ± 8 y, male 61 %) with 138 leads implanted including 42 ICD, 48 CRT and 16 upgrade procedures. A majority (83 %) was under anti-thrombotic therapy. UGVP was successful in 96.8 %. Mean insertion time for 1.78 guidewires per patient was 4.4 ± 4.4 min. Guidewires insertion time reached its plateau after 10 patients. One pocket hematoma (1.4 %) was drained during a mean follow-up of 12 ± 5 months. The control group included 28 patients (12 subclavian, 16 cephalic; 15 ICD, 18 CRT, 4 upgrade procedures), with a mean insertion time of 10 ± 8 min, for 1.95 guidewires per patient (p < 0.0005). Conclusion UGVP is feasible and safe even for complex device implantations including CRT/ICD and upgrade procedures.