Incidence Of Pocket Hematoma Research Articles

Access site bleeding complications comparing oral anticoagulation therapy with NOACs and VKAs in patients with atrial fibrillation undergoing cardiac implantable device intervention

Abstract Funding Acknowledgements Type of funding sources: None. Background Atrial fibrillation is frequent in patients undergoing cardiac implantable electronic device (CIED) intervention. Such population require oral anticoagulation therapy, which increases risk of procedure related bleeding. There is a lack on data on procedure-related bleeding outcome with non-vitamin K antagonist anticoagulants (NOACs) vs vitamin K antagonist anticoagulants (VKAs) in patients with AF undergoing CIED intervention. Study purpose Aim of the present stud was to evaluate whether NOACs have a safety benefit compared to VKAs in terms of fewer hemorrhagic complications at the site of CIED implant. Methods Consecutive AF patients receiving NOACs or VKAs at the time of CIED procedure were included in this observational, retrospective, monocentric investigation. Primary endpoint was the incidence of post-intervention clinically significant pocket hematoma. Multivariate analysis was performed to investigate the association between covariates and the primary endpoint. Results A total of 311 patients were enrolled, 146 on NOACs and 165 on VKAs. The incidence of pocket hematoma was 3.4% in the NOAC vs 13.3% in the VKA group (p=0.002) (Figure 1). Primary outcome-free survival at 30-days was 96.6 % in patients on NOACs and 86.0% in those on VKAs (p=0.019) (Figure 2). Multivariate analysis, adjusted by propensity-score calculation of inverse-probability-weighting, showed a significantly lower occurrence of pocket hematoma in patients receiving NOACs vs VKAs (HR 0.35, 95% CI 0.13-0.96, p=0.042). Such NOACs benefit was confirmed vs patients on VKAs without peri-procedural bridging with low-molecular weight heparin (HR 0.34, 95% CI 0.11-0.99, p=0.048). The incidence of pocket infection, surgical pocket evacuation, ischemic events and major bleeding complications at 30 days (secondary endpoints) was similar in the two groups. Conclusion Among patients with AF undergoing implantable cardiac defibrillator or pace-maker intervention, the use of NOACs vs VKAs is associated with significant reduction of post-procedural pocket hematoma, regardless of bridging with low molecular-weight heparin in the VKA group.

Access Site Bleeding Complications with NOACs versus VKAs in Patients with Atrial Fibrillation Undergoing Cardiac Implantable Device Intervention.

There are no data on procedure-related bleeding outcome with non-vitamin K antagonist anticoagulants (NOACs) versus vitamin K antagonist anticoagulants (VKAs) in patients with atrial fibrillation (AF) undergoing cardiac implantable electronic device (CIED) intervention. Our aim was to evaluate whether NOACs have a safety benefit even in terms of fewer hemorrhagic complications at the site of CIED implant. Consecutive AF patients receiving NOACs or VKAs at the time of CIED procedure were included in this observational, retrospective, and monocentric investigation. Primary endpoint was the incidence of post-intervention pocket hematoma. A total of 311 patients were enrolled, 146 on NOACs, and 165 on VKAs. The incidence of pocket hematoma was 3.4% in the NOAC versus 13.3% in the VKA group (p = 0.002). Primary outcome-free survival at 30-days was 96.6% in patients on NOACs and 86.0% in those on VKAs (p = 0.019). Multivariate analysis, adjusted by propensity-score calculation of inverse-probability-weighting, showed a significantly lower occurrence of pocket hematoma in patients receiving NOACs versus VKAs (HR 0.35, 95% CI 0.13–0.96, p = 0.042). Such NOACs benefit was confirmed versus patients on VKAs without peri-procedural bridging with low-molecular-weight heparin (HR 0.34, 95% CI 0.11–0.99, p = 0.048). The incidence of pocket infection, surgical pocket evacuation, ischemic events, and major bleeding complications at 30 days (secondary endpoints) was similar in the two groups. In conclusion, our data suggest that, among patients with AF undergoing implantable cardiac defibrillator or pacemaker intervention, the use of NOACs versus VKAs may be associated with significant reduction of post-procedural pocket hematoma, regardless of bridging with low-molecular-weight heparin in the VKA group. These results are hypothesis generating and need to be confirmed in a specific randomized study.

Influence of peri-procedural management of direct oral anticoagulants on the incidence of pocket hematoma in patients undergoing cardiac rhythm device implantation – The StimAOD study

Direct oral anticoagulants (DOAC) are commonly used in patients undergoing rhythm device implantation, exposing to an increased risk of pocket hematoma. However, the optimal perioperative strategy for DOAC management remains unclear. We performed a multicentre prospective observational study of patients receiving DOAC and undergoing pacemaker or defibrillator implantation. The primary endpoint was clinically relevant hematoma (CRH) within 30 ± 5 days after implantation. Any hematoma included CRH and non-clinically relevant hematoma. We aimed to describe practices, assess the impact of DOAC interruption before and after the procedure and identify predictors of CRH. In total, 789 patients were included, median age 80 [30–102], 36.4% women. CHA 2 DS 2 -VASc score was 4 [0–8] and 16.5% had a history of stroke. Defibrillators were implanted in one fifth. Antiplatelet therapy accounted for 18.5%. Overall DOAC were interrupted 40.8 ± 45.3 h prior the procedure and resumed 38.8 ± 40.3 h later. Pre- and post-procedural heparin bridging were observed in 8.2% and 3.9%, and shortened anticoagulation interruption (32.1 ± 48.8 vs. 55.8 ± 45.5 h, P < 0.001 and 22 ± 26.2 vs. 39.5 ± 40.6 h, P < 0.001, respectively). Postoperative bridging increased by 4.1 the risk of any hematoma up to 5.9 when associated with preoperative bridging. CRH occurred in 3.3%. In multivariate analysis dual antiplatelet therapy, defibrillator implantation and CHA 2 DS 2 -VASc score 0-1 were strong predictors of CRH ( Table 1 ). Among CHA 2 DS 2 -VASc score 0-1, postoperative anticoagulation was resumed earlier in those with a hematoma (29.6 ± 15.1 vs. 65.7 ± 70.5 hours, P = 0.007). Finally, thromboembolic events were low (0.63%). Dual antiplatelet therapy, defibrillator and CHA 2 DS 2 -VASc score 0-1 majored the risk of CRH. Timing of DOAC interruption and resumption were not predictive of CHR, however postoperative period seemed to be at high-risk of hematoma especially when bridging is performed. These findings have strong impact for clinical practice.

Implantable cardioverter-defibrillator-related procedures and associated complications in continuous flow left ventricular assist device recipients: A multicenter experience.

BackgroundLimited data exist regarding complication rates of implantable cardioverter-defibrillators (ICD) and cardiac resynchronization therapy devices (CRT-D) in patients with left ventricular assist devices (LVAD).ObjectiveWe describe the incidence and characteristics of ICD- and CRT-D-related procedures and complications in a multicenter LVAD cohort.MethodsA total of 537 LVAD patients with a pre-existing ICD or CRT-D from 5 centers were included. Details on device type, device therapies, procedural complications, and long-term survival were analyzed.ResultsOf 537 patients, 280 had a CRT-D and 257 had ICD only. During a median follow-up of 538 days, 126 patients underwent generator replacement with significantly higher rate in the CRT group (79 [28.2%] vs 47 [18.3%], P = .0006). Device-related complications occurred in 36 (13%) CRT-D and 20 (8%) ICD patients (P = .06). Incidence of pocket hematoma (3.2% vs 2.7%), infection (4.3% vs 1.6%), and lead malfunction (3.1% vs 2.8%) was similar in both groups, with no effect of device complication on long-term survival (log-rank P = .7). There was a higher incidence of post-LVAD antitachycardia pacing for ventricular arrhythmias in the CRT-D group compared to the ICD group (35% vs 26%, P = .03).ConclusionCardiac implantable electronic device–related procedures are common in LVAD patients. Compared to ICD only, continued CRT-D therapy post-LVAD results in a significantly higher number of generator changes and a trend towards higher device- or lead-related complications. Device-related complications were not associated with reduced survival.

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

Abstract 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 &amp;gt; 24 h or re-hospitalization for hematoma, b) interruption of antithrombotics, c) reoperation, d) hemoglobin drop &amp;gt; 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.

Prospective randomized study evaluating the effects of PerClot® (Polysaccharide Hemostatic System) application in patients with high bleeding risk undergoing cardiac rhythm device implantation

BackgroundThus far, the topic hemostatic agent PerClot® is used for surgical procedures. Data about the use of PerClot® for cardiac-rhythm-devices (CRD) implantation are missing. The aim of this study was to evaluate the safety and efficacy of PerClot® in patients with high bleeding risk. Methods and resultsIn this prospective randomized study we planned to include 150 patients admitted for CRD-Implantation receiving anticoagulation and/or dual-antiplatelet-therapy. Participants were randomized to receive PerClot® versus standard-of-care. The primary endpoint was the incidence of pocket hematoma. Safety endpoint was pocket infection. After a planned safety-interim-analysis the study was terminated early because of safety concerns.51 patients were included. The two groups were comparable with regard to age (73±11years vs. 74±10years; p=0.71), CHA2DS2VASc (3.6±1.5 vs. 4.0±1.5; p=0.27) and HASBLED-Score (2.4±1.1 vs. 2.5±1.0; p=0.98), CRD or procedure type, anticoagulant or anti-platelet therapy. The use of PerClot® resulted in a higher incidence of postoperative fever (7 (28%) vs. 0 (0%); p=0.004), higher C-Reactive Protein (66.1±50.5mg/l vs. 25.9±22.5mg/l; p=0.002); and higher postoperative white blood cell count (13.5±4.3/nl vs. 8.8±2.6/nl; p<0.001). Hematoma formation did not differ significantly (p=0.14). Reoperation was not necessary in any patient. ConclusionThis first randomized controlled study for the topical use of the hemostatic agent PerClot® in CRD implantation was terminated early by the safety monitoring board because of an augmented rate of fever and inflammatory markers in the PerClot® group. The addition of PerClot® does not suggest a benefit with regard to the frequency of pocket hematoma.

Safety of continuing warfarin therapy in patients undergoing cardiac resynchronization therapy device implantation

Background: Continuing warfarin therapy is considered safe for patient undergoing pacemaker or implantable cardioverter defibrillator procedures, but less evidence exists for patients undergoing cardiac resynchronization therapy (CRT) device implantation. Subjects and Methods: We retrospectively evaluated 136 consecutive patients who received a CRT device. Three periprocedural anticoagulation strategies were utilized: Group 1, continuation of therapeutic warfarin; Group 2, cessation of warfarin with heparin bridging; and Group 3, cessation of anticoagulation temporarily. Groups were compared on the incidence of complications. Results: Of the 136 patients, 87 (64%) were in Group 1, 18 (13%) were in Group 2, and 31 (23%) were in Group 3. Group 1 patients had an international normalized ratio of 2.3 ± 0.5, which was significantly higher than the other two groups. Coronary sinus dissection occurred in four patients: Three in Group 1 and one in Group 2, but no patient experienced pericardial effusion or tamponade. Group 2 experienced a higher incidence of pocket hematoma (P = 0.0065) and a longer length of hospital stay (P = 0.0069) than Group 1. Transient ischemic attack occurred in one patient in Group 3. Conclusion: Continuing warfarin with therapeutic international normalized ratio seems to be safe in individuals undergoing CRT device implantation.

216-41: Electrocautery compared to electrical plasma surgery in patients undergoing device generator replacement - A prospective randomized study

Background: As the number of cardiac implantable electronic devices is constantly growing, the need for generator replacement surgeries increases. Generator replacement is associated with surgical complications such as pocket hematoma, infections and lead damages. Conventional electrocautery has been shown to bear the potential of lead insulation damage by focal heating. Recently a novel electrical plasma surgery tool (PEAK PlasmaBladeTM, Medtronic Inc., Minneapolis, MN, USA) has been introduced. This tool works at lower peak temperature levels and is able to cut wet tissue as well. The aim of this prospective randomized single center study was to compare effectiveness and safety of the electrical plasma surgery tool with a conventional electrocautery tool in device generator replacement surgeries. Methods: After randomization, 78 patients undergoing device generator replacement were treated either with a conventional radiofrequency electrocautery tool (Vio 100C, Erbe Elektromedizin GmbH, Tübingen, Germany; n = 38) or the electrical plasma surgery tool (n = 40). The primary endpoint was the duration from skin incision to generator enucleation. Secondary endpoints were procedural durations, incidence of pocket hematoma, device infections and lead damages. Results: The duration to generator enucleation was significantly shorter in the plasma surgery group [8 ± 5 min. vs 13 ± 10 min.; p = 0.002]. Secondary endpoints did not significantly differ between the two groups. In two patients a cross over from the conventional treatment group to the plasma surgery group was necessary due to severe fibrotic adhesions. Conclusion: Application of an electrical plasma surgery tool for generator replacement surgery leads to a significant shortening of duration to generator enucleation whereas complication rates did not significantly differ.

Dual antiplatelet therapy increases pocket hematoma complications in Chinese patients with pacemaker implantation.

ObjectiveTo assess the prevalence of the bleeding complications in pacemaker implanted patients receiving different antiplatelet regimens, and the influence of each regimen on hospital stays after device implantation.MethodsWe prospectively enrolled 364 patients receiving the cardiac rhythm device implantations in Fuwai Hospital from July 2012 to December 2013. Bleeding complications including pocket hematoma, hemothorax, cardiac tamponade and blood transfusion requirement were measured as endpoints. Post operation hospital stay was also included in the endpoints.ResultsBleeding complications were detected in 15 patients (14 with hematoma, one with hemothorax) out of all 364 patients (4.12%). Dual antiplatelet therapy (DAT) significantly increased hematoma (19.3%) compared with aspirin treatment (ASA) (3.2%, P = 0.001) and no antiplatelet therapy (1.9%, P < 0.001). There was no significant difference in incidence of pocket hematoma between the ASA group and the control group (P = 0.45). The post procedure hospital stay was longer in DAT group (5.45 ± 2.01 days) compared to those in the ASA group (3.65 ± 1.37 days, P < 0.05) or control group (3.99 ± 2.27 days, P < 0.05). Pocket hematoma was considered an independent predictor of hospital stay prolongation (OR: 5.26; 95% CI: 1.56−16.64; P = 0.007).ConclusionsAmong the Chinese patients undergoing device implantation in this study, the use of dual antiplatelet agents significantly increased the risk of pocket hematoma complications and led to a longer hospital stay. Use of aspirin alone did not increase the risk.

Effect of different antiplatelet or anticoagulation therapy on postoperative pocket hematoma after electrophysiological devices placement

Objective To investigate the effect of different antiplatelet or anticoagulation therapy on postoperative pocket hematoma after electrophysiological devices placements (EPD). Methods The selected patients were taking anti-platelet or anticoagulation therapy and needed implanted permanent pacemaker, cardiac resynchronization therapy and implantable cardioversion defibrillator in our Beijing Anzhen hospital from January 2010 to January 2013. According to the type of therapy, patients were divided into 4 groups: dual anti-platelet therapy (DAP, aspirin and clopidogrel) group, low-molecular-weight heparin (LMWH, enoxaparin) bridging group, aspirin alone (ASA) group and warfarin group. The incidences of pocket hematoma after electrophysiological devices placements were observed in groups. Results A total of 324 patients were enrolled in the study. The incidence of pocket hematoma was higher in LMWH bridging group than in the other 3 groups 〔18.25% (15/81) vs. 4.93% (4/81), 3.70% (3/81), 2.47% (2/81), all P 0.05). The multiple logistic regression analysis revealed that LMWH bridging therapy was an independent risk factor for the development of pocket hematoma: patients with LMWH bridging therapy were 7 fold more likely to develop pocket hematomas than the individuals with other treatment (OR=7.124, 95% CI: 1.861-27.271). Conclusions LMWH bridging therapy increases the risk of development of pocket hematomas after electrophysiological devices placement. Key words: Aspirin; Warfarin; Heparin; Heart-assist devices; Hematoma

Pocket Hematoma: A Call for Definition.

Pocket hematoma is a common complication of cardiac implantable electronic device procedures and a potential risk factor for device infections, especially in patients on oral anticoagulation or antiplatelet treatment. There is a wide variability in the incidence of pocket hematoma and bleeding complications in the literature and the major cause for this seems to be the variability of the used definitions for hematomas. The lack of generally accepted definition for pocket hematoma renders the comparisons across the studies difficult. In this article, we briefly review the current literature on this issue and propose a uniform definition for pocket hematoma and criteria for grading the severity of hematoma in clinical practice and research.

Use of oxidized regenerated cellulose to prevent pocket hematomas after cardiac electronic device implantation in patients on anticoagulants or dual antiplatelet therapy

Up to 30% of patients remain on anticoagulants or antiplatelet agents at the time of implantation of cardiac electronic devices [1]. The use of clopidogrel alone, dual antiplatelet therapy (DAPT) or intravenous heparin significantly increases the risk of hematoma post device implantation [2–4]. Then again, withholding anticoagulants or antiplatet therapy peri-operatively may result in thromboembolic complications. Surgicel® FibrillarTM Hemostat (Ethicon Inc. USA) is a form of oxidized regenerated cellulose (ORC), a plant-based topical hemostatic agent that is used adjunctively in surgical procedures to help control capillary, venous and small arterial hemorrhage when conventional methods of hemostasis are impractical [5,6]. It is fully absorbablewithin 14 days and has in-vitro bactericidal properties [6,7]. We describe a pilot series of 42 patients who received Surgicel® FibrillarTM Hemostat during implantation of cardiac pacemakers or defibrillators whilst remaining on anticoagulants or DAPT. We aim to assess the safety and efficacy of ORC in prevention of pocket hematomas in this group of individuals at high risk of bleeding complications postimplant. In our institution, patients on antiplatelet therapy or warfarin remain on these medications when they undergo implantation of cardiac pacemakers or defibrillators. The international normalized ratio (INR) is titrated to less than 3. A pocket hematoma is defined as a palpable mass that protrudes N2 cm (minor hematoma) or N4 cm (significant hematoma). Between 1 April 2012 and 31 January 2013, we identified 42 patients onwarfarin or DAPT inwhom implantation of cardiac electronic devices was indicated (See Table 1). Their mean age was 68 ± 8 years, 28 were males. Eighteen patients were onwarfarinwith a mean INR of 2.5 ± 0.2 peri-operatively. Of these 18 patients, 3 were on both warfarin and clopidogrel 75 mg daily. Twenty-four patients were on DAPT consisting of aspirin 100 mg and clopidogrel 75 mg daily. Each patient received 1 dose of intravenous cephazolin 1 h prior to the procedure. During implantation, a subcutaneous pocket was created in the pre-pectoral region with the use of electrocautery. All visible bleeding sites, especially arterial ones, were meticulously cauterized. Vascular access was obtained through subclavian or axillary venous punctures under fluoroscopy guidance. Each lead was implanted via a separate venous puncture. Following placement of the pulse generator in the pocket, Surgicel® FibrillarTM Hemostat was peeled off in the desired amount and the pieces fitted into the pocket, above and to the sides of the pulse generator. The wound was then closed in 2 layers with absorbable sutures and a sterile dressing applied. Each patient was prescribed a 1-week course of oral cephalexin post-implant. They were examined daily until hospital discharge and they returned for outpatient follow-up on Day 7 and 1 month postimplant for wound inspection and device check. Subsequent follow-up was at 3 to 6 monthly intervals. There was no case of pocket hematoma or infection with a mean follow-up period of 6 ±2.3 months. Despite the continued use of warfarin and DAPT peri-operatively, none of our patients developed pocket hematoma or infection. ORC appeared to be safe and effective in prevention of bleeding complications in high-risk individuals during device implantation. In the setting of anticogulation or DAPT, capillary or venous ooze is common. Conventional methods to achieve hemostasis may prove ineffective, especially in the confined areas of the subcutaneous pocket. The benefit of topical hemostatic agents in such settings is controversial. Milic et al. reported that the administration of fibrin sealant in patients on anticoagulation eliminated post-operative pocket hematomas after pacemaker implantation [8]. Recently, Ohlow et al. published data showing that the use of D-Stat HemostatTM (Vascular Solutions Inc. USA) tended towards a higher incidence of pocket hematoma requiring evacuation and pocket infections [9]. ORC is ready for use straight out of the packaging. It can be cut or peeled into customized sizes and fitted into the subcutaneous pocket. It provides a matrix for platelet adhesion and aggregation by melting into bleeding tissue, thereby serving as a hemostatic adjunct in the control of capillary, venous and small arterial hemorrhage. It is fully absorbed from the sites of implantation within 1 to 2 weeks with no tissue reaction. In-vitro studies highlight its bactericidal properties [7]. Given such features, ORC may potentially be suitable as a topical hemostat during cardiac electronic device implantation. Our study is limited by its small sample size and non-randomized design with no control arm. Large randomized trials comparing ORC versus standard care are necessary to fully evaluate the effectiveness and

Chronic kidney disease is an independent predictor of pocket hematoma after pacemaker and defibrillator implantation

The aim of this investigation was to determine additional predisposing factors of pocket hematoma formation in patients undergoing anti-arrhythmic device surgery. Initially, we performed a retrospective chart review of 459 patients on warfarin therapy who underwent anti-arrhythmic device surgery (pacemaker or defibrillator implantation, generator replacement, or lead revision) between April 2004 and September 2008 to determine whether continuation of anticoagulation or cessation of anticoagulation, with or without bridging therapy, was the preferred approach. In those patients who developed pocket hematoma, we then analyzed factors that might predispose to hematoma formation. The incidence of pocket hematoma in the entire group was 2.2% (n = 10). Forty-eight percent of the patient group was on continued warfarin (n = 220), 27% on bridging therapy with intravenous heparin or subcutaneous enoxaparin (n = 123) and 66% were on antiplatelet therapy (aspirin or clopidegrol or both; n = 303) at the time of device implantation. Twelve percent of the patients had chronic kidney disease (n = 55). In multivariate regression analysis, after adjusting for anticoagulation and antiplatelet agents, chronic kidney disease was found to be a significant risk factor for pocket hematoma formation after ICD and pacemaker placement. An increase of 1.0mg/dl in creatinine levels was associated with a nearly twofold increase in hematoma formation (OR, 1.99; 95% CI, 1.22-3.21; p = 0.03). Chronic kidney disease is a significant risk factor for pocket hematoma formation after pacemaker and ICD placement, independent of anticoagulation and antiplatelet agents.

Pocket Hematoma After Pacemaker or Implantable Cardioverter Defibrillator Surgery: Influence of Patient Morbidity, Operation Strategy, and Perioperative Antiplatelet/Anticoagulation Therapy

Pocket hematoma is a common complication after pacemaker or implantable cardioverter defibrillator (ICD) implantation. Thus, we investigated the influence of patient comorbidity, implantation strategy, operator experience, antiplatelet therapy, and anticoagulation therapy on hematoma rate. Between 1990 and 2002, a total of 3,164 devices (pectoral pacemakers, 2,792; ICDs, 372) were implanted at our institution. Predictors of hematoma occurrence were determined prospectively and were analyzed by multivariate regression analysis. Operator experience was graded by individual implantation number, as follows: low, < 50; medium, 50 to 100; and high, > 100. The incidence of pocket hematoma was 4.9%, leading to prolonged hospitalization in 2.0% of all patients. Reoperation for pocket hematoma was required in 1.0% of patients. High-dose heparinization (hazard ratio [HR], 4.2), combined acetylsalicylic acid (ASA)/thienopyridine treatment after coronary stenting (HR, 5.2), and low operator experience (HR, 1.6) were independently predictive of hematoma development. Therapy with ASA alone did not increase the hematoma rate compared to patients who did receive antiplatelet or anticoagulation therapy (3.1% vs 2.5%, respectively; difference not significant). In patients with nonvalvular atrial fibrillation, postoperative high-dose heparinization substantially increased the hematoma rate (10.7% vs 2.9%, respectively; p < 0.001) without reducing the rate of arterial embolism within the first month after implantation (0.18% vs 0.21%, respectively; difference not significant). The infection rate (0.28% within 3 months after implantation) was not influenced by the presence of the pocket hematoma. The use of high-dose heparinization and combined ASA/thienopyridine treatment are highly predictive for the occurrence of intraoperative bleeding and pocket hematoma in patients who have undergone pacemaker and ICD surgery. We propose recommendations for the management of antiplatelet and anticoagulation therapy in patients undergoing these interventions.