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Pocket Hematoma: A Call for Definition
Abstract
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. This article is protected by copyright. All rights reserved.
This article is protected by copyright. All rights reserved.
... 23 Prolonged post-operative hospital length of stay after CIED implantation was defined as a stay that extended beyond what is generally established in our institution, i.e. over 1 day for PM and 2 days for ICD/CRT. The secondary endpoints were orthostatic intolerance during the first mobilization out of bed and the presence of the post-procedural complications of bleeding, pocket haematoma (Grade 1: ecchymosis or mild effusion in the pocket, no swelling or pain to device pocket; Grade 2: large effusion in the pocket leading to swelling and causing functional impairment or pain to device pocket; Grade 3: any pocket haematoma requiring interventions), 24 lead dislodgement and pneumothorax. 1,24 Data collection All data, particularly those referring to study-specific endpoints, were collected using a standardized data sheet. ...
... The secondary endpoints were orthostatic intolerance during the first mobilization out of bed and the presence of the post-procedural complications of bleeding, pocket haematoma (Grade 1: ecchymosis or mild effusion in the pocket, no swelling or pain to device pocket; Grade 2: large effusion in the pocket leading to swelling and causing functional impairment or pain to device pocket; Grade 3: any pocket haematoma requiring interventions), 24 lead dislodgement and pneumothorax. 1,24 Data collection All data, particularly those referring to study-specific endpoints, were collected using a standardized data sheet. Pre-existing conditions and sociodemographic data were recorded for each patient. ...
... Almost all patients successfully completed mobilization the day after CIED implantation, with two patients delayed in mobilization to Day 2 due to CIED therapy complications. The median time to first mobilization was 23 (21)(22)(23)(24) h. [21][22][23]26 Primary outcomes occurred in 48 of 90 patients (53.3%). ...
Aims
To describe the incidence and impact of adverse clinical events (ACEs) during first 24 h of bedrest of patients after cardiac implantable electronic device (CIED) implantation.
Methods and results
We conducted a prospective observational study of patients aged over 18 years undergoing elective placement of permanent bicameral pacemaker (PM), cardiac resynchronization therapy (CRT) PM, CRT defibrillator, or implantable cardioverter-defibrillator. Patients were maintained on bedrest post-operatively for 24 h and delirium, post-operative urinary retention, severe post-operative pain, pressure ulcer, and sleep disturbance were recorded using standardized assessments. Of 90 patients, 66 (73.3%) were male and average age was 76 ± 10 years. The median time to first mobilization was 23 (21–24) h. The adverse clinical events occurred in 48/90, with severe pain (38/90), sleep disturbance (12/90), delirium (9/90), and urinary retention requiring urinary catheterization (8/90) most frequent. Patients receiving implantable cardioverter-defibrillator or CRT defibrillator experienced ACEs significantly more frequently than those receiving PM. Adverse clinical event was associated with prolonged hospital stay [odds ratio (OR) 2.5; 95% confidence interval (CI) 1.16–6.17]. Patients with delirium were more dependent for daily living activities on admission (OR 8.0; 95% CI 1.55–41.3).
Conclusion
Adverse clinical events frequently occur post-insertion of a CIED and impact patient clinical course and experience. The progressive increase in ageing and frailty of CIED implant candidates requires special nursing attention to improve patients’ satisfaction and to prevent increased healthcare resource use.
... Several studies have assessed the occurrence of pocket hematoma, from 0.9% to 28.7%. (16,(22)(23)(24)(25)(26). In BRUISE CONTROL trial, the clinically significant device-pocket hematoma occurred in 12 of 343 patients (3.5%) in the continued-warfarin group, as compared with 54 of 338 (16.0%) in the heparin bridging group (27). ...
... In the present study, the incidence of hematoma was 24.0% upon discharge, while the incidence of grade 3 hematoma was only 4.4%. This discrepancy could be attributed to some factors, including differences in study design, baseline characteristics of patients, inconsistencies in the definition of pocket hematoma and non-use of electrocautery (9,22). In our trial, electrocautery was not employed since the operators do not use electrocautery routinely and the hematoma was defined in accordance with the classification of De Sensi et al. who categorized pocket hematomas into three grades based on clinical phenomena and required interventions. ...
... In our trial, electrocautery was not employed since the operators do not use electrocautery routinely and the hematoma was defined in accordance with the classification of De Sensi et al. who categorized pocket hematomas into three grades based on clinical phenomena and required interventions. All the clinical findings around the pocket and those leading to therapeutic interventions were recorded in our study, whereas a number of previous studies only included clinically significant hematomas equivalent to grade 3 hematoma in our trial (17,22,26). ...
Background
A pocket hematoma is a well-recognized complication that occurs after pacemaker or defibrillator implantation. It is associated with increased pocket infection and hospital stay. Patients suffering from atrial fibrillation and undergoing cardiovascular electronic implantable device (CIED) surgery are widely prescribed and treated with direct oral anticoagulants (DOACs). In this study, the use of a novel compression device was evaluated to examine its ability to decrease the incidence of pocket hematomas following device implantation with uninterrupted DOACs.
Methods
A total of 204 participants who received DOACs and underwent CIED implantation were randomized into an experimental group (novel compression device) and a control group (elastic adhesive tape with a sandbag). The primary outcome was pocket hematoma, and the secondary outcomes were skin erosions and patient comfort score. Grade 3 hematoma was defined as a hematoma that required anticoagulation therapy interruption, re-operation, or prolonged hospital stay.
Results
The baseline characteristics of both groups had no significant differences. The incidence of grades 1 and 2 hematomas was significantly lower in the compression device group than in the conventional pressure dressing group (7.8 vs. 23.5 and 2.0 vs. 5.9%, respectively; P < 0.01). Grade 3 hematoma occurred in 2 of 102 patients in the experimental group and 7 of 102 patients in the control group (2.0 vs. 6.9%; P = 0.03). The incidence rates of skin erosion were significantly lower, and the patient comfort score was much higher in the compression device group than in the control group ( P < 0.01). Multivariable logistic regression analysis showed that the use of novel compression device was a significant protective factor for pocket hematoma (OR = 0.42; 95% CI, 0.29–0.69, P = 0.01).
Conclusions
The incidence of pocket hematomas and skin erosions significantly decreases when the proposed compression device is used for patients undergoing device implantation with uninterrupted DOACs. Thus, the length of hospital stay and re-operation rate can be reduced, and patient comfort can be improved.
Clinical Trial Registration
http://www.chictr.org.cn , identifier: ChiCTR2100049430.
... Two experienced cardiologists who had no knowledge of the treatment assignments performed daily examinations until hospital discharge, and were responsible for diagnoses and making all decisions about the management of pocket hematoma. The grading scale for a hematoma in this study is listed in the following: ecchymosis or mild effusion in the pocket, no swelling or pain to device-pocket is classified as grade 1 hematoma, large effusion in the pocket leading to swelling and causing functional impairment or pain to devicepocket is classified as grade 2 hematoma, grade 3 hematoma is defined that any pocket hematoma requiring reoperation and/ or resulting in prolongation of hospitalization (defined as extended hospitalization or rehospitalization for >24 h, post- index surgery, primarily due to hematoma) and/or requiring interruption of oral anticoagulation (defined as a reversal or intentional withholding, in response to a pocket hematoma, resulting in subtherapeutic anticoagulation for >24 h) [11]. The secondary outcomes were adverse skin reactions, the need for positional adjustments of the sandbag, and the patient-comfort score. ...
... We preferred to use the hematoma definition utilized in the study of De Sensi et al. [11], which classifies hematoma into the following three grades based on clinical findings and the required interventions: grade 1 hematoma corresponds to mild effusion or ecchymosis not requiring any therapeutic intervention, with watchful waiting being applied; grade 2 hematoma is when the effusion is larger and causes pain or functional impairment, requiring minor therapeutic interventions; and grade 3 hematoma corresponds to clinically significant hematoma. All clinical phenomena occurring around the pocket and those leading to therapeutic interventions were reported for all of the cases analyzed in the present study, whereas previous studies only included grade 3 hematomas. ...
Aim/objective
Aim to evaluate the safety and effectiveness of a pocket compression device in patients undergoing cardiovascular implantable electronic device (CIED) implantation.
Material and methods
This randomized controlled trial included 54 patients in the control group (elastic adhesive tape) and 54 patients in the experimental group (pocket compression device). A sandbag was positioned over the pocket after CIED implantation, using elastic adhesive tape in the control group and a novel pocket compression device in the experimental group. The primary outcome was the incidence of pocket hematomas, and the secondary outcomes were adverse skin reactions, the need for sandbag positional adjustments, and patient comfort.
Results
The distributions of age, sex, and clinical and procedure characteristics was not significantly different between the two groups (P>0.05). The occurrence of hematomas was lower when using the pocket compression device than in the control group (13.0% vs. 44.4%, P<0.001). The incidence rates of hematomas of grades 1 and the grade 2 hematomas were significantly lower in the experimental group than in the control group (13.0% vs. 31.5%, 0% vs. 11.1% respectively, [all P<0.05]). The incidence rates of adverse skin reactions and sandbag positional adjustments were much lower and the patient comfort score was significantly higher in the experimental group than in the control group (all P<0.001).
Conclusion
A pocket compression device can significantly decrease the incidence of pocket hematomas, adverse skin reactions, and positional adjustments when patients are undergoing CIED, which can improve patient comfort and decrease the nursing workload.
ClinicalTrials.gov
NCT04389398
... Swelling in the pocket exceeding the size of the generator without warmth and erythema and change of skin color to purple are accepted as hematoma. 4 Pocket infection is diagnosed when swelling with local erythema, warmth, pain, drainage and purulence, erosion or dehiscence occurred, which required total extraction of the CIED system. Local sign of infection in suture line was followed conservatively and was not accepted as pocket infection. ...
... About 2-9% up to 33 % of CIED implantation procedures result in pocket hematoma. 4,16 Prior anticoagulant and/or antiplatelet therapy and switching oral anticoagulant drugs to heparin facilitates pocket hematoma. 17 In our study cohort, two-thirds of the patients continued their antiplatelet medications. ...
Objective: There is a lack of data in the current literature regarding the spontaneous progression of inflammatory biomarkers early after cardiovascular implantable electronic device (CIED) placement. In our study we aimed to detect C-reactive protein (CRP) and white blood cell count (WBC) trends in the 5 days following CIED implantation. Methods: We retrospectively investigated a total of 235 patients who received CIEDs between 2012 and 2016 in our heart center. The levels of CRP and WBC for one day before and for the following 5 days after the procedure were noted in 4 serial measurements. The longitudinal course of CRP and WBC and their association with various parameters were analyzed with linear mix model of repeated measurements. Results: Totally 235 patients were screened; 36 patients excluded due to lack of serial CRP and WBC measurements, 44 patients excluded due to occurrence of a factor that may potentially affect CRP and WBC level. Finally 153 patients with a median age of 67 (IQR 58-74), 41 (26.8%) of whom were female, were included in the study. CRP values indicated a significant trend and made a peak in the second estimation (between 48-72 hours) after the procedure (Beta[β]: 0.208; Standard Error [S.E]: 0.015; p< 0.001). Age and procedure duration longer than 1 hour emerged as leading factors for high level of CRP (β:0.004; S.E: 0.002; p=0.05 and β: 0.208; S.E: 0.015; p= 0.02, respectively). The relation between time and WBC count was not statically significant (β: -0.129; S.E: 0.06; p=0.06). Conclusion: Progression of CRP after CIED implantation demonstrates a significant trend. Age and procedure duration longer than 1 hour are leading factors for high levels of CRP. There is statistically non-significant relation between WBC levels and time in 5 days of procedure.
... As Masiero alludes to in her article, there is no consensus for the definition of clinically significant haematoma, and the lack of a definition itself has been the subject of previous literature. 2 This makes amalgamation and interpretation of the current body of evidence difficult. In this study, criteria for significant haematoma were those requiring re-operation and interruption of anticoagulation. ...
... In an attempt to standardize and create a more clinical classification of pocket haematoma, we have devised a pictorial scale that we used to audit haematoma predictors in our own centre (see Figure 1). This grading scale was an expansion of the classification offered by De Sensi et al. 2 and also suggests treatment options. We defined a clinically significant haematoma as Grade 2 or Grade 3 on our scale. ...
... However, uninterrupted anticoagulation could increase the risk of bleeding, and device pocket haematoma is one of the most common complications associated with cardiac rhythm management device surgery with a reported incidence of 2.1-9.5% [6]. Device pocket haematoma is defined as ecchymosis or bleeding in the area of the device generator pocket [7]. The formation of a haematoma is of clinical importance due to its association with an increased device pocket infection risk [8,9]. ...
Aim:
The objective of the study is to systematically evaluate the safety and efficacy of peri-procedural utilization of anticoagulation therapy during cardiovascular implantable electronic device procedures.
Material and methods:
The review materials were based on comprehensive retrieval of randomized controlled trials and observational studies published until April 2023. Studies which compared different management strategies of long-term anticoagulation therapy during peri-procedural cardiac rhythm device implantation and compared the complications of bleeding and/or thromboembolic events were selected and reviewed.
Results:
Studies analysing non-vitamin K oral anticoagulants interruption versus continuation during peri-procedural implantable cardiac device surgery found no statistically significant difference in bleeding or thromboembolic complications between these strategies. Studies comparing non-vitamin K oral anticoagulants with vitamin K antagonists also showed no statistically significant difference. One study comparing uninterrupted warfarin with interrupted warfarin with heparin bridging reported a reduced incidence of clinically significant device pocket haematoma in patients with continued warfarin treatment (relative risk = 0.19; 95% confidence interval: 0.10 to 0.36; p < 0.001). A sub-analysis of one study comparing dabigatran versus warfarin with heparin bridging and without bridging reported a lower risk of pocket haematoma with dabigatran when compared to warfarin with heparin bridging (risk difference: -8.62%, 95% confidence interval: -24.15 to -0.51%; p = 0.034). Both bleeding and thromboembolic complications were rare.
Conclusions:
The traditional method of vitamin K antagonists interruption with heparin bridging is less safe than continuing vitamin K antagonists at therapeutic levels. Both continuation and interruption strategies of non-vitamin K anticoagulants during cardiac device surgery seem to be safe and appropriate.
... Transcatheter arterial embolization by Onyx rubber was performed in the arterial aneurysm and distal vasculature ( Figure 2B). Onyx rubber is a non-viscous embolic agent made from a mixture of ethylenevinyl alcohol copolymer, dimethyl sulphoxide and tantalum powder [5]. It is a novel liquid embolism commonly used in the treatment of cerebrovascular diseases. ...
Background:
Haematoma is one of the main complications associated with pacemaker implantation. Pseudoaneurysm is a rare condition that is not easy to identify and is often overlooked.
Case summary:
A female patient diagnosed with high-grade atrioventricular block underwent permanent pacemaker implantation. During the operation, puncturing a small branch of the right subclavian artery developed into a pseudoaneurysm and resulted in further haematoma formation. Conventional treatment of compression haemostasis and haemostatic drugs was not effective. A series of timely transcatheter arterial embolizations avoided serious complications.
Conclusion:
More possible conditions should be taken into consideration as haematoma is discovered, and timely treatment might prevent severe adverse events.
... Sensi et al. 23 have introduced a 3-level grading system of hematomas, with our definition of CSH corresponding to hematoma grade 3. ...
Purpose:
Clinically significant pocket hematoma (CSH) is a common complication to cardiac implantable electronic device (CIED) surgery. We aimed to evaluate predictors of CSH after CIED surgery.
Methods:
We performed a nationwide population-based prospective cohort study with systematic patient chart review of all Danish patients undergoing CIED surgery during a 12-month period. Multiple logistic regression analysis was used to estimate adjusted odds ratios (aOR) with 95% confidence intervals for association between predictors and CSH.
Results:
We included 5918 consecutive patients, 63% males, mean age 72.6 years. A total of 148 (2.5%) patients experienced CSH, including 10 patients (0.2%) requiring re-operation with hematoma evacuation. The risk of CSH was significantly increased in patients treated with aspirin (aOR 1.8; 1.2-2.7), aspirin and clopidogrel (aOR 3.9; 2.3-6.5), or heparin (aOR 2.1; 1.1-4.1), and in patients with INR≥2.0 (aOR 2.0; 1.2-3.2). Patients operated by low-volume operators (aOR 2.7; 1.6-4.6) or undergoing more complex CIED surgery such as cardiac resynchronization therapy (aOR 2.0; 1.1-3.5) or dual-chamber defibrillator (aOR 2.1; 1.2-3.8) also had significantly increased CSH risk.
Conclusion:
In a large nationwide cohort of consecutive patients undergoing CIED surgery, the risk of CSH was 2.5%, with 0.2% necessitating evacuation. CSH risk was increased both in patients receiving aspirin, dual antiplatelet therapy or continued vitamin K-antagonist therapy. Dual antiplatelet therapy had the highest risk (aOR) of CSH. Both low operator volume and more complex CIED surgery were independently associated with higher CSH risk. These data should be considered when planning CIED surgery.
... This definition of clinically significant hematoma is in accordance with the landmark BRUISE CONTROL trials. [4,16] The secondary endpoint was any systemic thromboembolic complication (i. e., transient ischemic attack, stroke) < 30 days after surgery. ...
Background
Direct oral anticoagulants (DOACs) are the preferred choice of oral anticoagulation in patients with atrial fibrillation (AF). Randomized trials have demonstrated the efficacy and safety of DOAC in patients undergoing a cardiac implantable electronic device procedure (CIED); however, there is limited real-world data.
Objective
To evaluate the outcome of patients undergoing an elective CIED procedure in a tertiary referral center with an interrupted DOAC or continued vitamin K antagonist (VKA) regimen.
Methods
This was a retrospective single-center study of consecutive patients with AF undergoing an elective CIED procedure between January 2016 and June 2019. The primary endpoint was a clinically significant pocket hematoma < 30 days after surgery. The secondary endpoint was any systemic thromboembolic complication < 30 days after surgery.
Results
Of a total of 1,033 elective CIED procedures, 283 procedures were performed in patients with AF using oral anticoagulation. One-third of the procedures were performed under DOAC (N = 81, 29%) and the remainder under VKA (N = 202, 71%). The DOAC group was younger, had less chronic renal disease, more paroxysmal AF and a lower HAS-BLED score. The VKA group more often underwent a generator change only in comparison to the DOAC group. Clinically significant pocket hematoma occurred in 5 patients (2.5%) in the VKA group and did not occur in the DOAC group (P = 0.33). There were no thromboembolic events reported.
Conclusion
In patients with AF undergoing an elective CIED procedure, the risk of a pocket hematoma and a systemic thromboembolic event is comparably low when using either continued VKA or interrupted DOAC.
... Infective complications were defined following the EHRA international consensus [8] and included: superficial incisional infection and CDI with 2 variants: pocket infection and CIED systemic infection/infective endocarditis. For precise pocket hematoma classification, we used the hematoma grading based on the recently published classification [18]. ...
Background:
Cardiac implantable electronic device (CIED) infections are associated with significant morbidity, mortality and increased health care expenses. Apart from standard systemic antibiotic therapy locally acting agents are under investigation as potential approach for prevention of this complication.
Aims:
The aim of our study was to summarize our experience with gentamycin-collagen sponge (GCS) in multi-component prevention strategy of cardiac implantable electronic device infection.
Methods:
We retrospectively analyzed medical records of 312 consecutive patients who underwent CIED-related surgery and had at least 6 months follow-up. All the individuals had GCS applied during surgery. An incidence of CIEDs-related infection in our group was compared to risk level calculated according to commonly used scores. An analysis of cost-effectiveness was also performed.
Results:
Incidence of CIED-related infection, defined as primary endpoint, occurred relatively rarely (0.33%) as compared to the infection risk calculated according to commonly used scores (PADIT - 0.83%; CIED-AI - 0.90% or Mittal score - 1.00%; P <0.001 - for all). We did not record any complication related to GCS. We analyzed cost-effectiveness of our GCS-based approach, which appeared to be financially beneficial (number needed to treat 149-200; difference of CIED infection treatment cost and GCSs price was 5093-26525 $).
Conclusions:
We conclude that: 1) use of GCS to reduce CIEDs infections is feasible and safe; 2) our multi-component prevention strategy involving the GCS application seems to significantly reduce rate of CIED infection and it is cost-effective.
... As previous studies report on different immunogenetic potential of various collagen implants, demonstrating increased antibody titers against collagen in vivo in some of them [12], C-reactive protein and Immunoglobulin E were determined in all patients 24 h after the implantation procedure. Table 1 Grading of pocket hematomas and definition of pocket infections [2,14,15] Grading of pocket hematoma (as proposed in 12) Definition of pocket infection (adapted from 13) Grade 1 Ecchymosis or mild effusion, no swelling or pain to CIED pocket ...
Purpose
We sought to assess the safety and effectiveness of three different devices: (1) vacuum drainage system, (2) hemostatic gelatin sponge (Stypro®), and (3) compression device (Premofix®) compared to standard of care (control) in patients undergoing cardiac implantable electronic device (CIED) implantation receiving anticoagulation and/or dual antiplatelet therapy (DAPT).
Methods
We enrolled all consecutive patients admitted for first permanent CIED implantation receiving anticoagulation and/or DAPT into a prospective registry. The primary endpoint (1°EP) was a composite of hematoma grade > 1 and pocket infection.
Results
We included 406 patients (median age 73 years, 71% male) of whom 103 (25%) received a vacuum drainage system, 99 (24%) received Stypro®, 103 (25%) received Premofix®, and 101 (25%) were in the control group. One hundred eighty patients (44%) were treated with anticoagulation (median INR 2.0), 176 (43%) received DAPT, and 50 (12%) both. The occurrence of the 1°EP was reduced by Stypro® (hazard ratio (HR) 0.38 (95% confidence interval (CI) 0.16–0.94) and Premofix® (HR: 0.37 (95% CI 0.15–0.90)) compared to controls (p < 0.05 for both). The incidence of hematoma grade 2 or 3 was exclusively lowered by Premofix® compared to control (6% versus 15%; p < 0.05) and was not affected by the type of CIED, INR (≥ 2.5 versus < 2.5), body mass index (≥ 30 versus < 30), or CIED implantation under anticoagulation plus DAPT. The vacuum drainage system did not affect the 1°EP or the incidence of hematoma.
Conclusions
In patients receiving anticoagulation and/or DAPT undergoing CIED implantation, the use of Premofix® and Stypro® significantly lowered the 1°EP occurrence compared to control. Premofix® additionally lowered the frequency of pocket hematomas >grade 1.
... patients (0.4% per year) after implantation or pacemaker replacement [8,20,21]. Clinically, it may appear very different -from the small sizes of bloody infarcts, highlighting the edges of the pocket through the palpable outlines of the device to massive tumors located in the vicinity of the pocket, accompanied by an infarct occupying a large part of the chest, or even the entire body, which leads to a significant decline in the morphotic parameters of the blood, often requiring immediate intervention, including transfusion of blood products [30] ( Figure 2). Patients usually complain about the pain of this area and the feeling of spreading. ...
In the past years we have been observing the dynamic development of electrotherapy, as evidenced by the steadily rising number of implanted pacemakers (PM), as well as devices used in the treatment of dangerous arrhythmia and heart failure, such as implantable cardioverter defibrillators (ICD) and cardiac resynchronisation therapy (CRT-P/D). This is a consequence of the ageing of the populations of the majority of developed countries and also the gradually widening indications for the use of such devices. Along with the observed rise in the number of new implantations, the number of complications of electrotherapy is rising as well. In view of the increase in the incidence of complications, it is necessary to systematize the knowledge on this subject, because there is still no official classification of this type of complication and guidelines for dealing with such cases do not appear to cover the scale of the problem. In addition, late complications of electrotherapy play the most important role, in which case the removal of the entire pacing system, transvenous lead extraction (TLE), is a challenge due to the older age of leads strongly attached to the venous walls and endocardium of the heart cavity. The present paper presents a modern classification of electrotherapy complications and discusses the types of complications according to the most recent literature reports. Moreover, the diagnosis and management of particular types of complications with the assessment of indications for TLE are discussed.
... Pocket formation requires mechanical separation of subcutaneous tissues, typically superficial to the pectoralis major muscle, in an area similar to the size of the device being implanted. A considerable disproportion in this respect, i.e. the size of the pocket being much larger than necessary, increases the a risk of a hematoma or Twiddler's syndrome [4,6]. ...
Background:
The final stage of a conventional de-novo cardiac implantable electronic device (CIED) implantation procedure with transvenous lead insertion involves the formation of a pocket by tissue separation superficial to the pectoralis major muscle in the right or left infraclavicular region, where the device is subsequently placed. Over time, a scar "capsule" forms around the CIED as a result of normal biological remodeling.
Materials and methods:
The purpose of this study was to analyze the structure and present the variations of CIED capsules observed during device replacement. The nature and extent of this local tissue remodeling, which had occurred from the time of device implantation to its replacement in 2016 (10 ±3.1 years), was analyzed in 100 patients (mean age 77.1±14.5 years), including 45 women and 55 men.
Results:
The largest type of "capsules" (70% of cases) were those with similar thickness of both walls or a slightly thicker posterior (<1.0mm) than anterior wall (<0.5mm). The second most common capsule type (23% of cases) was characterized by a significantly thicker posterior wall of scar tissue (˃1.0mm). The third group of capsules was characterized by various degrees of wall calcification (7% of cases).
Conclusions:
The extent and nature of scar tissue structure in the CIED pocket walls seems to correlate with the relative position of cardiac lead loops with respect to the device itself; where the more extensive scarring likely resulting from pocket wall irritation in the capsule formation phase due to lead movements underneath the device. The group of cases with calcified capsules was characterized by "old" device pockets (˃ 13 years) and the oldest population (patients in their 80s and 90s).
... There is no doubt that this fact complicates the analysis of data from different studies. 15 Niederhuber J. E. (2012) suggested that PH is a palpable swelling of the device pocket exceeding the size of implanted EPD. It was recommended to refer to ultrasound investigation in a disputable case. ...
Pocket hematoma (PH) is a common complication of implantations of cardiac electrophysiological devices with occurring at a particularly high rate in patients on oral anticoagulation or antiplatelet treatment. Different pharmacological agents with hemostatic effect are used to avoid PH. We supposed that the vasoconstrictor effects of epinephrine may reduce bleeding extent and be effective in prevention of PH. Maitre is the first clinical trial conducted with an aim to show the safety and efficacy of epinephrine in PH prophylaxis. We randomized 133 patients to receive either epinephrine or saline solution, which were added to a local anesthetic administered during pacemaker implantation. In cases of diffuse bleeding a method of pocket drainage was effectively used. Results showed that risk of PH was significantly higher in the group receiving epinephrine. We conclude that a local epinephrine effect may lead to a false impression of adequate hemostasis and force a surgeon to refuse from drainage insertion.
Pocket hematoma (PH) is a common complication of pacemaker implantations which prolongs hospitalization and may demand surgical revision in some cases. According to the data from different researchers PH rate varies from 2 to 7%. It depends on number of factors including a need for anticoagulation therapy. We present a review of design of multicenter clinical trial evaluating safety and efficacy of application of hemostatic agent Haemoblock for pocket hematoma reduction in patients taking oral anticoagulants.
Background: Pocket hematoma is the most common complication after procedures involving cardiac implantable electronic devices (CIEDs). Furthermore, pocket hematomas increase the risk of device infection. Unless severe, a pocket hematoma is usually managed conservatively because specific treatment is unavailable. Aspiration is not recommended as it can cause infection. This study explored whether lowering the risk of infection by aseptically removing the hematoma at an early stage would be possible through aspiration, investigated the effectiveness of treatment with aspiration for pocket hematoma, and analyzed the characteristics of patients with pocket hematoma.Methods: Via chart review, we retrospectively analyzed 570 patients who underwent CIED implantation or replacement between January 2011 and January 2021. Aspiration was performed only on grade 2 and 3 hematomas.Results: Pocket hematomas were identified in 80 patients (14%). Of these 80 patients, 52 (65%) were treated with aspiration only; six (7.5%), with aspiration plus surgical procedure; five (6.25%), with the surgical procedure only; and 17 (21.25%), with conservative treatment. Out of 58 patients treated with aspiration only and aspiration plus surgical procedure, 52 (89.65%) were treated with aspiration only, while six (10.34%) required more procedures (e.g., hematoma evacuation, Barovac insertion, or device reposition with flap surgery). However, none of these six patients exhibited an infection symptom possibly caused by aspiration.Conclusion: Out of 80 patients with hematoma, 58 were treated with aspiration, and none showed infection symptoms that could be caused by aspiration. This suggests that aspiration can be an effective treatment if performed aseptically.
Since the insertion of the first implantable pacemaker in 1958 and the first implantable cardioverter-defibrillator (ICD) in 1980, there has been a rapid uptake and evolution in cardiac implantable device therapies. These cardiac devices have dramatically improved the survival and provided symptomatic relief for a broad range of cardiac conditions., and rates of device implantation have increased rapidly. As a result, both cardiologists and non-cardiologists will need to be familiar with complications associated with device therapy.
Background:
To establish a novel time-saving and safe suture method for cardiac implantable electronic device(CIED) implantation.
Methods:
From January 2017 to April 2020, a total of 1317 patients scheduled for CIED procedure were consecutively enrolled in this study. Wound closure of all patients were prospectively assigned either to low-density suture spacing single layer suture group (single-layer group) or traditional two layer suture group (two-layer group). The effects of two closure methods on wound healing and pocket related complications were compared.
Results:
There were no significant differences in age, gender, BMI, comorbid diseases (diabetes, hypertension, coronary heart disease, and chronic kidney disease), and antiplatelet or anticoagulant drug use between the two groups. The number of suture stitches in the single-layer group was significantly less than that in the two-layer group [3.03(3∼4) vs 7.17(7∼10), p<0.001], the suture time in the single-layer group was significantly shorter than that in the two-layer group [190.57(167∼256) s vs 493.36(452∼655) s, p<0.001], and the incidence of clinically significant hematoma in the single-layer group was comparable to that in the two-layer group (0.7% vs 0.3%, P = 0.742). Additionally, there were no significant differences in the incidence of pocket infection, dehiscence and keloid between the two groups.
Conclusion:
Novel single-layer suture with low-density suture spacing is feasible and associated with a low incidence of wound dehiscence or infection for CIED implantation. This article is protected by copyright. All rights reserved.
Although the recently reported results of the PADIT study [1] indisputably bring a positive message by showing that the infection rate within the first year after cardiac implantable electronic device (CIED) implantation in advanced care systems was “only” 1% in high-risk patients, infection associated with the use of CIED (CIEDI) remains a serious complication leading to significant morbidity and mortality. These infections can be the result of initial pocket infection, usually due to surgical site contamination (more frequently) or secondary to hematogenous seeding of the leads or pocket during an episode of bacteremia due to remote septic foci or associated with either intravascular catheters or invasive procedures. As previously discussed in Chaps. 3 and 4, the principal agents involved in the development of CIEDI are gram-positive Staphylococci, and the main factors promoting the infective process can be classified into (a) patient-related, (b) device-related, (c) procedure-related, and (d) related to operators’ experience. In this chapter, we will focus on the various aspects of periprocedural modifiable risk factors: anticoagulation, antisepsis, antibiotic prophylaxis, and wound care. We will discuss both available evidence supporting standard approaches and recently introduced devices to improve CIED procedures. On the contrary, prevention of CIEDI through adoption of new CIED technologies, patient-tailored choice of the device, implanting procedure, and long-term follow-up are discussed in Chaps. 10 and 12.
Aims:
Pocket hematoma is a common complication of cardiac implantable electronic device (CIED) procedures. the aim of the study was to research the clinical factors associated with pocket hematoma formation after CIED implantation or replacement and to identify the best perioperative antithrombotic management.
Methods:
We retrospectively analyzed 500 consecutive patients who underwent to CIED implantation or replacement at our center from November 2014.
Results:
Among our population, 206 patients (41.2%) were on anticoagulant therapy at the time of the intervention: 68 (13.6%) on ongoing Warfarin; 111 (22.2%) on low-molecular-weight heparin (LMWH); and 27 (5.4%) on ongoing direct oral anticoagulants. Antiplatelet therapy was present in 262 (52.4%) patients: in particular, 50 (10%) were on dual antiplatelet therapy, 64 (12.8%) were on single antiplatelet therapy and anticoagulant therapy, whereas 12 (2.4%) were on anticoagulant with dual antiplatelet therapy.Incidence of pocket hematoma after CIEDs implantation was of 4.6%. Considering the different perioperative anticoagulant strategies, patients on LMWH presented the higher hematoma rate [11/100 patients (11.0%), P < 0.001]. At the multivariate analysis, anticoagulant with dual antiplatelet therapy (P = 0.021, OR 6.3, IC 1.3-30.8), left ventricular ejection fraction (LVEF) less than 30% (P < 0.001, OR 7.4, IC 2.7-20.4), and use of LMWH (P = 0.008, OR 3.8, IC 1.4-10.6) resulted the strongest predictors of pocket hematoma (Hosmer test = 0.899).Considering replacement procedures, incidence of pocket hematoma was of 4.4%. The incidence was higher after ICD/CRT-D replacement. The majority of pocket hematoma occurred in patients with mechanical valve prosthesis (3/4 cases, 75%, P < 0.001).
Conclusion:
The use of LMWH and a low LVEF expose patients to a higher risk of pocket hematoma after CIED procedures. Anticoagulant with dual antiplatelet therapy and LMWH should be avoided.
Background:
The perioperative management of anticoagulation with the use of subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation is still evolving.
Objective:
The purpose of this study was to assess whether it is safe to perform S-ICD implantation with uninterrupted warfarin.
Methods:
This is a multi-center retrospective review of patients undergoing S-ICD implantation between October 1, 2012 and June 30, 2017. Forty-eight patients underwent successful S-ICD implantation during the study period. The most common indication for implantation was primary prevention of sudden cardiac death. In 23 (47.9%) patients, warfarin was continued without any interruption. In 25 (52.1%) patients, warfarin was interrupted prior to implantation. The incidence of clinically significant lateral pocket hematoma was compared in the 2 groups.
Results:
The mean international normalized ratio was 2.0 ± 0.4 in the uninterrupted group and 1.4 ± 0.4 for the interrupted group. A total of 7 patients developed a hematoma at the lateral pocket. No patients developed a hematoma at the parasternal pockets. Six patients in the uninterrupted group (26.1%) and one patient in the interrupted group (0.04%) developed a significant lateral pocket hematoma (p = 0.04). The concomitant use of dual antiplatelet therapy did not increase the risk of hematoma. There was no significant difference between HASBLED and CHA2 DS2 VASc scores between the groups. None of the patients with a hematoma developed infection or required hematoma evacuation.
Conclusions:
The uninterrupted use of warfarin in the perioperative period of S-ICD implantation is associated with an increased risk of lateral pocket hematoma. This article is protected by copyright. All rights reserved.
In patients undergoing cardiac device implantation, anticoagulant and antiplatelet therapy are associated with an increased risk of pocket hematoma. In case of vitamin K antagonist therapy, a strategy of continued warfarin with no heparin bridge showed a reduction of pocket hematoma. Evidence regarding antiplatelet therapy management is limited. This is a single center observational study which reflects our systematic approach to the problem. In 2012 we proposed an improved management protocol for anticoagulant and antiplatelet therapy (no-bridge protocol) based upon individual thromboembolic risk stratification, non-interruption of oral anticoagulation, no bridge with heparin and elastic adherence compression bandage. The primary end point was the incidence of clinically significant pocket hematoma in the first 30 days after implantation. A total of 1035 patients were enrolled, of whom 522 received the standard management and 513 the new protocol. The primary end point occurred in 34 patients of the standard management group and 8 patients of the no-bridge protocol group (6.5% vs 1.6%, p<0.001). Patients in the standard management group had a higher incidence of pocket infections (2.3% vs 0.6%, p=0.02), lead dislodgements (4.8 vs 2.1%, p=0.02) and thromboembolic events (1.3% vs 0.0%, p<0.01). On a multivariate analysis, heparin and coronary artery disease were independent predictors of pocket hematoma (RR 3.48, 95% CI 1.55-7.83 and 2.43, 95% CI 1.25-4.76, respectively), while the no-bridge protocol was associated with a reduction of pocket hematoma (RR 0.33, 95% CI 0.14-0.76). New anticoagulant and antiplatelet therapy management protocol was associated with a reduced incidence of clinically significant pocket hematomas, thromboembolic events, pocket infections and lead dislodgements.
Background
The BRUISE CONTROL trial (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial) demonstrated that a strategy of continued warfarin during cardiac implantable electronic device surgery was safe and reduced the incidence of clinically significant pocket hematoma (CSH). CSH was defined as a post-procedure hematoma requiring further surgery and/or resulting in prolongation of hospitalization of at least 24 h, and/or requiring interruption of anticoagulation. Previous studies have inconsistently associated hematoma with the subsequent development of device infection; reasons include the retrospective nature of many studies, lack of endpoint adjudication, and differing subjective definitions of hematoma.
Objectives
The BRUISE CONTROL INFECTION (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial Extended Follow-Up for Infection) prospectively examined the association between CSH and subsequent device infection.
Methods
The study included 659 patients with a primary outcome of device-related infection requiring hospitalization, defined as 1 or more of the following: pocket infection; endocarditis; and bloodstream infection. Outcomes were verified by a blinded adjudication committee. Multivariable analysis was performed to identify predictors of infection.
Results
The overall 1-year device-related infection rate was 2.4% (16 of 659). Infection occurred in 11% of patients (7 of 66) with previous CSH and in 1.5% (9 of 593) without CSH. CSH was the only independent predictor and was associated with a >7-fold increased risk of infection (hazard ratio: 7.7; 95% confidence interval: 2.9 to 20.5; p < 0.0001). Empiric antibiotics upon development of hematoma did not reduce long-term infection risk.
Conclusions
CSH is associated with a significantly increased risk of infection requiring hospitalization within 1 year following cardiac implantable electronic device surgery. Strategies aimed at reducing hematomas may decrease the long-term risk of infection. (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial [BRUISE CONTROL]; NCT00800137)
Background:
Many patients requiring pacemaker or implantable cardioverter-defibrillator (ICD) surgery are taking warfarin. For patients at high risk for thromboembolic events, guidelines recommend bridging therapy with heparin; however, case series suggest that it may be safe to perform surgery without interrupting warfarin treatment. There have been few results from clinical trials to support the safety and efficacy of this approach.
Methods:
We randomly assigned patients with an annual risk of thromboembolic events of 5% or more to continued warfarin treatment or to bridging therapy with heparin. The primary outcome was clinically significant device-pocket hematoma, which was defined as device-pocket hematoma that necessitated prolonged hospitalization, interruption of anticoagulation therapy, or further surgery (e.g., hematoma evacuation).
Results:
The data and safety monitoring board recommended termination of the trial after the second prespecified interim analysis. Clinically significant device-pocket hematoma occurred in 12 of 343 patients (3.5%) in the continued-warfarin group, as compared with 54 of 338 (16.0%) in the heparin-bridging group (relative risk, 0.19; 95% confidence interval, 0.10 to 0.36; P<0.001). Major surgical and thromboembolic complications were rare and did not differ significantly between the study groups. They included one episode of cardiac tamponade and one myocardial infarction in the heparin-bridging group and one stroke and one transient ischemic attack in the continued-warfarin group.
Conclusions:
As compared with bridging therapy with heparin, a strategy of continued warfarin treatment at the time of pacemaker or ICD surgery markedly reduced the incidence of clinically significant device-pocket hematoma. (Funded by the Canadian Institutes of Health Research and the Ministry of Health and Long-Term Care of Ontario; BRUISE CONTROL ClinicalTrials.gov number, NCT00800137.).
Complications after cardiac implantable electronic device (CIED) treatment, including permanent pacemakers (PMs), cardiac resynchronization therapy devices with defibrillators (CRT-Ds) or without (CRT-Ps), and implantable cardioverter defibrillators (ICDs), are associated with increased patient morbidity, healthcare costs, and possibly increased mortality.
Population-based cohort study in all Danish patients who underwent a CIED procedure from May 2010 to April 2011. Data on complications were gathered on review of all patient charts while baseline data were obtained from the Danish Pacemaker and ICD Register. Adjusted risk ratios (aRRs) with 95% confidence intervals were estimated using binary regression. The study population consisted of 5918 consecutive patients. A total of 562 patients (9.5%) experienced at least one complication. The risk of any complication was higher if the patient was a female (aRR 1.3; 1.1-1.6), underweight (aRR 1.5; 1.1-2.3), implanted in a centre with an annual volume <750 procedures (0-249 procedures: aRR 1.6; 1.1-2.2, 250-499: aRR 2.0; 1.6-2.7, 500-749: aRR 1.5; 1.2-1.8), received a dual-chamber ICD (aRR 2.0; 1.4-2.7) or CRT-D (aRR 2.6; 1.9-3.4), underwent system upgrade or lead revision (aRR 1.3; 1.0-1.7), had an operator with an annual volume <50 procedures (aRR 1.9; 1.4-2.6), or underwent an emergency, out-of-hours procedure (aRR 1.5; 1.0-2.3).
CIED complications are more frequent than generally acknowledged. Both patient- and procedure-related predictors may identify patients with a particularly high risk of complications. This information should be taken into account both in individual patient treatment and in the planning of future organization of CIED treatment.
This guideline addresses the management of patients who are receiving anticoagulant or antiplatelet therapy and require an elective surgery or procedure.
The methods herein follow those discussed in the Methodology for the Development of Antithrombotic Therapy and Prevention of Thrombosis Guidelines. Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines article of this supplement.
In patients requiring vitamin K antagonist (VKA) interruption before surgery, we recommend stopping VKAs 5 days before surgery instead of a shorter time before surgery (Grade 1B). In patients with a mechanical heart valve, atrial fibrillation, or VTE at high risk for thromboembolism, we suggest bridging anticoagulation instead of no bridging during VKA interruption (Grade 2C); in patients at low risk, we suggest no bridging instead of bridging (Grade 2C). In patients who require a dental procedure, we suggest continuing VKAs with an oral prohemostatic agent or stopping VKAs 2 to 3 days before the procedure instead of alternative strategies (Grade 2C). In moderate- to high-risk patients who are receiving acetylsalicylic acid (ASA) and require noncardiac surgery, we suggest continuing ASA around the time of surgery instead of stopping ASA 7 to 10 days before surgery (Grade 2C). In patients with a coronary stent who require surgery, we recommend deferring surgery > 6 weeks after bare-metal stent placement and > 6 months after drug-eluting stent placement instead of undertaking surgery within these time periods (Grade 1C); in patients requiring surgery within 6 weeks of bare-metal stent placement or within 6 months of drug-eluting stent placement, we suggest continuing antiplatelet therapy perioperatively instead of stopping therapy 7 to 10 days before surgery (Grade 2C).
Perioperative antithrombotic management is based on risk assessment for thromboembolism and bleeding, and recommended approaches aim to simplify patient management and minimize adverse clinical outcomes.
Current guidelines recommend stopping oral anticoagulation (OAC) and starting heparin infusion before implanting/replacing a pacemaker/implantable cardioverter-defibrillator (ICD) in patients with high risk for thrombo-embolic events. The aim of this study was to demonstrate that the maintenance of OAC during device implantation/replacement is as safe as bridging to intravenous heparin and shortens in-hospital stay.
A cohort of 101 consecutive patients with high risk for embolic events and indication for implant/replacement of a pacemaker/ICD were randomized to two anticoagulant strategies: bridging from OAC to heparin infusion (n = 51) vs. maintenance of OAC to reach an INR = 2 +/- 0.3 at the day of the procedure (n = 50). Haemorrhagic and thrombo-embolic complications were evaluated at discharge, 15 and 45 days after the procedure. A total of 4/51 patients (7.8%) from heparin group and 4/50 (8.0%) from the OAC group developed pocket haematoma following the implant (P = 1.00). One haematoma in each group required evacuation (1.9 vs. 2%, P = 1.00). No other haemorrhagic events or embolic complications developed during the follow-up. Duration of the hospital stay was longer in the heparin group [median of 5 (4-7) vs. 2 (1-4) days; P < 0.001].
Implant of devices maintaining OAC is as safe as bridging to heparin infusion and allows a significant reduction of in-hospital stay.
Background
This guideline addresses the management of patients who are receiving anticoagulant or antiplatelet therapy and require an elective surgery or procedure.
Methods
The methods herein follow those discussed in the Methodology for the Development of Antithrombotic Therapy and Prevention of Thrombosis Guidelines. Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines article of this supplement.
Results
In patients requiring vitamin K antagonist (VKA) interruption before surgery, we recommend stopping VKAs 5 days before surgery instead of a shorter time before surgery (Grade 1B). In patients with a mechanical heart valve, atrial fibrillation, or VTE at high risk for thromboembolism, we suggest bridging anticoagulation instead of no bridging during VKA interruption (Grade 2C); in patients at low risk, we suggest no bridging instead of bridging (Grade 2C). In patients who require a dental procedure, we suggest continuing VKAs with an oral prohemostatic agent or stopping VKAs 2 to 3 days before the procedure instead of alternative strategies (Grade 2C). In moderate- to high-risk patients who are receiving acetylsalicylic acid (ASA) and require noncardiac surgery, we suggest continuing ASA around the time of surgery instead of stopping ASA 7 to 10 days before surgery (Grade 2C). In patients with a coronary stent who require surgery, we recommend deferring surgery > 6 weeks after bare-metal stent placement and > 6 months after drug-eluting stent placement instead of undertaking surgery within these time periods (Grade 1C); in patients requiring surgery within 6 weeks of bare-metal stent placement or within 6 months of drug-eluting stent placement, we suggest continuing antiplatelet therapy perioperatively instead of stopping therapy 7 to 10 days before surgery (Grade 2C).
Conclusions
Perioperative antithrombotic management is based on risk assessment for thromboembolism and bleeding, and recommended approaches aim to simplify patient management and minimize adverse clinical outcomes.
The number of cardiac implantable electronic device (CIED) proce-duresisdramaticallyincreasingworldwide[1].Upto37–46%ofpatientsrequiringdevicesurgeryareonchronicoralanticoagulation(OAC)ther-apy [2]. Perioperative anticoagulation managementrepresentsadilem-mafor physicians, particularly in the subset of patients with moderate-to-high risk of arterial thromboembolic events. Current guidelinesrecommend interruption of anticoagulation and bridging with heparin[3]. However, such strategy has been associated with increased risk ofpocket hematoma(up to 20%) [4]. More recently, observational studiesshowed that continuing warfarin for cardiac rhythm device implanta-tion is safe and is associated with lower incidence of pocket hematoma[5,6]. Noteworthy, evidence from randomized controlled studies con-firmed the efficacy and safety of uninterrupted OAC as compared withheparin bridging [7,8]. Although uninterrupted OAC is associated withreduced bleeding, a large proportion of patients remain exposed to asubstantialriskofhemorrhagiccomplications.Preventionofhematomaformation duringCIEDsurgery is animportant challenge nowadays. In-deed,pockethematomarepresentsoneofthemainriskfactorsforlocaland systemic device-related infections, leading to increased patientmorbidity and health care costs [9,10]. To further reduce bleeding riskin this setting, some experts suggest that CIED procedures should beperformed within the safest INR ranges, thus maintaining INR valuesas low as possible, according to the type of procedure [11]. However, asystematic assessment of intrinsic bleeding risk is lacking in patientswith uninterrupted OAC undergoing CIED surgery. Therefore, the iden-tification of patients at higher bleeding risk would be advantageous tooptimize perioperative management. In recent years, the bleedingscores HASBLED, ATRIA and HEMORR
Background:
The FinPAC trial showed that the strategy of uninterrupted oral anticoagulation (OAC) was non-inferior to interrupted OAC for the primary outcome of bleeding and thromboembolic complications in patients undergoing cardiac rhythm management device (CRMD) implantation.
Methods:
We conducted a post hoc analysis of the FinPAC data to explore the incidence and predictors of significant (> 100 cm(2)) pocket hematoma after CRMD implantation among the study population (n = 447). A total of 213 patients were on OAC, 128 were on aspirin, and 106 on no antithrombotic therapy.
Results:
The incidence of significant pocket hematoma during hospital stay was significantly higher among patients using OAC (5.6%) and aspirin (5.5%) than in those with no antithrombotic medications (0.9%), but only one patient (0.8%) in the aspirin group needed revision of hematoma. Two patients (0.9%) in the OAC group and one (0.8%) in the aspirin group needed blood products. In multivariable regression analysis, no pre- procedural features predicted the significant hematoma in any of the groups.
Conclusions:
Clinically significant pocket hematoma is a rare complication after CRMD implantation in patients with ongoing therapeutic OAC. The incidence of significant pocket hematoma formation is similar in patients using OAC and those using aspirin.
Periprocedural management of oral anticoagulation (OAC) in patients undergoing cardiac rhythm management (CRM) device implantation is controversial. Prior studies demonstrate that uninterrupted OAC may be safe, but limited data from randomized trials exist.
We conducted a multicenter, randomized trial to evaluate the safety of uninterrupted OAC during CRM device implantation. Patients on long-term warfarin (N=213) treatment with contemporary indication for CRM device implantation were randomized to uninterrupted versus interrupted (2days) OAC therapy. The primary outcome included major bleeding events necessitating additional intervention and thromboembolic events during 4weeks follow-up.
The randomized groups were well matched in terms of bleeding and thromboembolic risk. Only one (1%) patient in the uninterrupted OAC group (N=106) needed blood transfusion due to rupture of proximal cephalic vein. Large hematomas were detected in 6% of patients in both groups, but there was no need for pocket revision in either group. Any pocket hematoma was observed in 35 patients (33%) in the uninterrupted OAC group and in 43 patients (40%) with interrupted OAC and uninterrupted OAC strategy was non-inferior to interrupted OAC (HR 0.86, 95%, p=0.001 for non-inferiority). One patient with interrupted OAC had stroke 3days after the procedure. Hospital stay was comparable in all patient groups.
Our randomized study demonstrates that CRM devices can be safely implanted without discontinuation of warfarin treatment.
The risk of cardiac device infection (CDI) is rising significantly, with several risk factors identified. The purpose of this study is to determine the rate of CDI at our center and to assess the associated risk factors, in order to define appropriate measures to prevent this complication. We retrospectively reviewed all cases of patients with CDI at St. George Hospital between February 1999 and July 2010. Each case was matched with three controls. We performed a descriptive and bivariate analysis to identify significant risk factors. Eighteen case patients and 54 control subjects met the inclusion criteria. An organism was recovered in 58 % of the cases. Significant risk factors included previous history of CDI (p < 0.001), recent manipulation (p < 0.001), trauma to the site of implant (p = 0.003), having a dual chamber/dual lead pacemaker (p = 0.002), and development of post-procedural hematoma (p = 0.012). Our findings complement the results of previous studies. We recommend a pre-procedural risk assessment and a thorough post-implantation follow-up to prevent the development of infective complications.
Many patients receiving cardiac rhythm devices have conditions requiring antiplatelet (AP) and/or anticoagulant (AC) therapy. Current guidelines recommend a heparin-bridging strategy (HBS) for anticoagulated patients with moderate/high risk for thrombosis. Several studies reported lower bleeding risk with continued oral anticoagulation rather than HBS. The best strategy for perioperative management of patients on AP therapy is less clear. The present study was designed as a meta-analysis of device implantation-associated bleeding complications using different AC/AP therapies.
PubMed and Cochrane Database searches identified articles based on design, outcomes, and available data. Device recipients were grouped as follows: no therapy, aspirin only, AC held, AC continued, dual AP, and HBS. The primary outcome was defined as a bleeding complication including hematoma, transfusion, or prolonged hospital stay. Thirteen articles were identified for analysis including 5978 patients. The combined incidence of bleeding complications was 274 of 5978 (4.6%), ranging from 2.2% (no therapy) to 14.6% (HBS). The estimated odds of bleeding were increased by 8.3 (95% CI, 5.5-12.9) times in the HBS group, 5.0 (95% CI, 3.0-8.3) for dual AP therapy, 1.7 (95% CI, 1.0-3.1) for AC held, 1.6 (95% CI, 0.9-2.6) for AC continued, and 1.5 (95% CI, 0.9-2.3) for aspirin only relative to the no therapy group. HBS significantly increased bleeding events compared with holding or continuing AC. Continuing AC did not increase bleeding events compared with no therapy.
Continuing AC appears safer than HBS for device implantation. Dual AP therapy but not continuing AC carries a significant risk of bleeding.
Switching warfarin for heparin has been a practice for managing periprocedural anticoagulation in high-risk patients undergoing device-related procedures. We sought to investigate whether continuation of warfarin sodium therapy without heparin bridging is safe and, when it is continued, the optimal international normalized ratio (INR) without increased bleeding risk at time of device-related procedure.
We retrospectively studied 766 consecutive patients taking warfarin long term who underwent device-related procedures. Patients were grouped by treatment: discontinued warfarin (-warfarin, n = 243), no interruption of warfarin (+warfarin, n = 324), and discontinued warfarin with heparin bridging (+heparin, n = 199). The study primary endpoint was systemic bleeding or formation of moderate or severe pocket hematoma within 30 days of the procedure. Thirty-one (4%) patients had bleeding events, including pocket hematoma in 29 patients. The bleeding events occurred more often for +heparin (7.0%) than -warfarin (2.1%) or +warfarin (3.7%, P = 0.029). For +warfarin group, INR of 2.0-2.5 at time of procedure did not increase bleeding risk compared with INR less than 1.5 (3.7% vs 3.4%; P = 0.72), but INR greater than 2.5 increased the bleeding risk (10.0% vs 3.4%; P = 0.029). Concomitant aspirin use with warfarin significantly increased bleeding risk than warfarin alone (5.6% vs 1.4%, P = 0.02). Median length of hospitalization was significantly shorter for +warfarin than +heparin (1 vs 6 days; P < 0.001).
Continuation of oral anticoagulation therapy with an INR level of <2.5 does not impose increased risk of bleeding for device-related procedures, although precaution is necessary to avoid supratherapeutic anticoagulation levels.
Prospective studies defining the risk associated with pacemaker or implantable cardioverter-defibrillator replacement surgeries do not exist. These procedures are generally considered low risk despite results from recent retrospective series reporting higher rates.
We prospectively assessed predefined procedure-related complication rates associated with elective pacemaker or implantable cardioverter-defibrillator generator replacements over 6 months of follow-up. Two groups were studied: those without (cohort 1) and those with (cohort 2) a planned transvenous lead addition for replacement or upgrade to a device capable of additional therapies. Complications were adjudicated by an independent events committee. Seventy-two US academic and private practice centers participated. Major complications occurred in 4.0% (95% confidence interval, 2.9 to 5.4) of 1031 cohort 1 patients and 15.3% (95% confidence interval, 12.7 to 18.1) of 713 cohort 2 patients. In both cohorts, major complications were higher with implantable cardioverter-defibrillator compared with pacemaker generator replacements. Complications were highest in patients who had an upgrade to or a revised cardiac resynchronization therapy device (18.7%; 95% confidence interval, 15.1 to 22.6). No periprocedural deaths occurred in either cohort, although 8 later procedure-related deaths occurred in cohort 2. The 6-month infection rates were 1.4% (95% confidence interval, 0.7 to 2.3) and 1.1% (95% confidence interval, 0.5 to 2.2) for cohorts 1 and 2, respectively.
Pacemaker and implantable cardioverter-defibrillator generator replacements are associated with a notable complication risk, particularly those with lead additions. These data support careful decision making before device replacement, when managing device advisories, and when considering upgrades to more complex systems.
This study was designed to assess the risk of significant bleeding complications in patients receiving antiplatelet or anticoagulation medications at the time of implantable cardioverter-defibrillator (ICD) device implantation.
Periprocedural management of antiplatelet or anticoagulation therapy at the time of device implantation remains controversial.
We performed a retrospective chart review of bleeding complications in all patients undergoing ICD or pacemaker implantation from August 2004 to August 2007. Aspirin or clopidogrel use was defined as taken within 5 days of the procedure. A significant bleeding complication was defined as need for pocket exploration or blood transfusion; hematoma requiring pressure dressing or change in anticoagulation therapy; or prolonged hospitalization.
Of the 1,388 device implantations, 71 had bleeding complications (5.1%). Compared with controls not taking antiplatelet agents (n = 255), the combination of aspirin and clopidogrel (n = 139) significantly increased bleeding risk (7.2% vs. 1.6%; p = 0.004). In patients taking aspirin alone (n = 536), bleeding risk was marginally higher than it was for patients taking no antiplatelet agents (3.9% vs. 1.6%, p = 0.078). The use of periprocedural heparin (n = 154) markedly increased risk of bleeding when compared with holding warfarin until the international normalized ratio (INR) was normal (n = 258; 14.3% vs. 4.3%; p < 0.001) and compared with patients receiving no anticoagulation therapy (14.3% vs.1.6%; p < 0.0001). There was no statistical difference in bleeding risk between patients continued on warfarin with an INR > or =1.5 (n = 46) and patients who had warfarin withheld until the INR was normal (n = 258; 6.5% vs. 4.3%; p = 0.50).
Dual antiplatelet therapy and periprocedural heparin significantly increase the risk of bleeding complications at the time of pacemaker or ICD implantation.
Many patients who need cardiac resynchronization therapy (CRT) require chronic anticoagulation. Current guidelines recommend discontinuation of warfarin and the initiation of anticoagulant "bridging" therapy during these procedures. We evaluated the safety of CRT-device (CRT-D) implantation without interruption of warfarin therapy.
A total of 123 consecutive patients requiring CRT-D therapy were enrolled, 49 identified as high risk for thromboembolic events who received either intravenous heparin, low molecular weight heparin, or warfarin therapy. The control group comprised 74 patients with low risk of thromboembolic events who required only cessation of warfarin perioperatively. Patients were evaluated at discharge and 15 and 30 days postoperatively for pocket hematomas, thromboembolic events, and bleeding. Patients' length of stay was also catalogued.
Patients in the bridging arm had a significant increase in the rate of pocket hematomas (4.1%[control] vs 5.0%[warfarin] vs 20.7%[bridging], P = 0.03) and subsequent longer length of stay (1.6 +/- 1.6 [control] vs 2.9 +/- 2.7 [warfarin] vs 3.7 +/- 3.2 [bridging], P < 0.001). Hematoma formation postoperatively was not different among patients undergoing an upgrade procedure versus those without preexisting cardiac rhythm devices (12% vs 6.2%, P = NS). Patients with a prosthetic mechanical mitral valve had a higher incidence of pocket hematoma formation (1.8% vs 20%, P = 0.03).
Our findings suggest that implantation of CRT-Ds without interruption of warfarin therapy in patients at high risk of thromboembolic events is a safe alternative to routine bridging therapy. This strategy is associated with reduced risk of pocket hematomas and shorter length of hospital stay. (PACE 2010; 400-406).
Current guidelines recommend stopping oral anticoagulation and starting bridging anticoagulation with intravenous heparin or subcutaneous enoxaparin when implanting a pacemaker or defibrillator in patients at moderate or high risk for thromboembolic events. A limited body of literature suggests that device surgery without cessation of oral anticoagulation may be feasible.
The purpose of this study was to evaluate the safety of device surgery in orally anticoagulated patients without interrupting warfarin therapy.
We performed a retrospective study of 459 consecutive patients on chronic warfarin therapy who underwent device surgery from April 2004 to September 2008. Warfarin was continued in 222 patients during the perioperative period. Warfarin was temporarily held and bridging therapy administered in 123 patients. Warfarin was temporarily held without bridging therapy in 114 patients.
There were no significant differences with regard to age, sex, or risk factors for thromboembolism in the three groups. Patients who continued taking warfarin had a lower incidence of pocket hematoma (P = .004) and a shorter hospital stay (P <.0001) than did patients in the bridging group. Holding warfarin without bridging is associated with a higher incidence of transient ischemic attacks (P = .01).
Temporarily interrupting anticoagulation is associated with increased thromboembolic events, whereas cessation of warfarin with bridging anticoagulation is associated with a higher rate of pocket hematoma and a longer hospital stay. Continuing warfarin with a therapeutic international normalized ratio appears to be a safe and cost-effective approach when implanting a pacemaker or defibrillator in patients with moderate to high thromboembolic risk.
Although routinely administered, definitive evidence for the benefits of prophylactic antibiotics before the implantation of permanent pacemakers and implantable cardioverter-defibrillators from a large double-blinded placebo-controlled trial is lacking. The purpose of this study was to determine whether prophylactic antibiotic administration reduces the incidence of infection related to device implantation.
This double blinded study included 1000 consecutive patients who presented for primary device (Pacemaker and implantable cardioverter-defibrillators) implantation or generator replacement randomized in a 1:1 fashion to prophylactic antibiotics or placebo. Intravenous administration of 1 g of cefazolin (group I) or placebo (group 2) was done immediately before the procedure. Follow-up was performed 10 days, 1, 3, and 6 months after discharge. The primary end point was any evidence of infection at the surgical incision (pulse generator pocket), or systemic infection related to be procedure. The safety committee interrupted the trial after 649 patients were enrolled due to a significant difference in favor of the antibiotic arm (group I: 2 of 314 infected patients-0.63%; group II: 11 of 335 to 3.28%; RR=0.19; P=0.016). The following risk factors were positively correlated with infection by univariate analysis: nonuse of preventive antibiotic (P=0.016); implant procedures (versus generator replacement: P=0.02); presence of postoperative hematoma (P=0.03) and procedure duration (P=0.009). Multivariable analysis identified nonuse of antibiotic (P=0.037) and postoperative hematoma (P=0.023) as independent predictors of infection.
Antibiotic prophylaxis significantly reduces infectious complications in patients undergoing implantation of pacemakers or cardioverter-defibrillators.
The purpose of this randomized study was to evaluate the prevalence of pocket hematomas in patients treated with heparin 6 h or 24 h after pacemaker or defibrillator implantation.
The risks of pocket hematoma and need for evacuation after device implantation have not been defined in patients who require anticoagulation.
Forty-nine consecutive patients with an indication for anticoagulation with heparin after implantable defibrillator or pacemaker implantation were randomized to receive intravenous heparin either 6 h (n = 26) or 24 h (n = 23) postoperatively. Both groups also received warfarin on a daily basis starting the evening of surgery. Twenty-eight patients who received postoperative warfarin alone and 115 patients who did not receive anticoagulation were followed up in a study registry.
A pocket hematoma developed in 6 of 26 patients (22%) who were treated with intravenous heparin 6 h postoperatively, as compared with 4 of 23 patients (17%) who were treated with intravenous heparin 24 h postoperatively (p = 0.7). In total, a pocket hematoma developed in 10 of 49 patients (20%) treated with heparin, 1 of 28 patients (4%) treated with warfarin alone and 2 of 115 (2%) patients who received no anticoagulation (p < 0.001).
Intravenous heparin initiation 6 h or 24 h after pacemaker or defibrillator implantation is associated with a 20% prevalence of pocket hematoma formation. Warfarin therapy or no anticoagulation is associated with only a 2% to 4% risk of pocket hematoma formation.
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.
Perioperative management of antithrombotic therapy: Antithrombotic therapy and prevention of thrombosis
- J D Douketis
- A C Spyropoulos
- F A Spencer
- M Mayr
- A K Jaffer
- M H Eckman
- A S Dunn
Douketis JD, Spyropoulos AC, Spencer FA, Mayr M, Jaffer AK,
Eckman MH, Dunn AS, et al. Perioperative management of
antithrombotic therapy: Antithrombotic therapy and prevention of
thrombosis, 9th ed: American College of Chest Physicians evidencebased clinical practice guidelines. CHEST 2012; 141:e326S-e350S.