Tips for preventing hematoma and infection after pacemaker implantation

Tips for preventing hematoma and infection after pacemaker implantation | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Tips for preventing hematoma and infection after pacemaker implantation Mohamed Ibrahim Sanhoury, Samir Rafla, Sherouk Ramzy, Mohamed ElFiky This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6494106/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background: The purpose of the study was to identify the clinical factors associated with hematoma formation after PM or ICD device implantation and how to prevent it. Methods: Fifty patients (group 1) were subjected to local measures such as electrocautery use and intra-pocket hydrogen peroxide (3%, diluted 50% with NaCl) application. Fifty other patients (group II) were implanted with the device during an era when cauterization was not available or not used, and no such solution was considered at that time. A hematoma was defined as palpable swelling with fluctuance over the device generator. Hematomas were categorized into 3 groups: Type 1 did not extend beyond 1 cm past the device margin, and type 2, hematoma, extended beyond 1 cm past the device margin. Clinically significant device-pocket hematoma (type 3) when hematoma needed evacuation. With this approach, device pocket evacuation was only performed in 4 cases. Good compression was adopted in all cases. In Group 1 there were four patients (8%) that had a mild hematoma and a grade 2 hematoma on one. Group 2: 9 (18%) had hematoma, and 5 (10 %) patients had hematoma grade 1. 2 patients had hematoma grade 2, and 2 patients had hematoma grade 3; the P value was <0.05. No infections had happened except in one in the grade 3 hematoma. So total types 2 or 3 were 5/100 patients (2.5%). So, the use of electrocautery and intra-pocket hydrogen peroxide was beneficial in preventing hematoma and infection. Critical Care & Emergency Medicine anticoagulants clopidogrel coronary artery disease dabigatran heparin pocket hematoma CIED PPM pocket compression vest pocket management systems Introduction Pocket hematoma is a recognized common complication after placement of a permanent pacemaker (PM) or implantable cardioverter-defibrillator (ICD). Pocket hematoma is associated with local discomfort and an increased risk of infection and may require surgical intervention (1-15). Major Adverse Events of Cardioverter-Defibrillator Implantation as Defined in the National Cardiac Data Registry—Implantable Cardioverter Defibrillator Registry (2). A separate analysis of the National Cardiac Data Registry (NCDR). Many patients are on antiplatelet or anticoagulant therapy for reasons such as having atrial fibrillation or stents implanted or other indications such as pulmonary emboli. The risk associated with discontinuing these medications results in an increased risk for stent thrombosis or stroke with possible catastrophic consequences. This risk needs to be considered when device implantation is considered and balanced against the significant increase in the prevalence of pocket hematoma, requiring pocket revision seen in patients on ASA, clopidogrel, or dual-antiplatelet therapy (16-29). Hematoma grading and interventions based on clinical findings (15) Grade 1: Ecchymosis or mild effusion in the pocket with no swelling or pain to the device pocket (watchful waiting) Grade 2: Large effusion in the pocket leading to swelling and causing functional impairment or pain to the device pocket Grade 3: Any pocket hematoma requiring reoperation and/or resulting in prolongation of hospitalization (defined as extended hospitalization or rehospitalization for >24 hours and/or need for interruption of OAC). Future Applications: In recent trials, pocket compression vests were demonstrated to lower the risk of pocket hematomas and infections in patients having CIED implantation (38). Aim: To find ways to minimize infection and identify clinical factors that lead to hematoma formation after PM or ICD device implantation, the study was conducted. Methods Patients were prospectively enrolled in the study after the successful completion of device implantation. Consent was obtained, and patients were then followed through hospital discharge. Data were obtained prospectively by a clinical nurse specialist who recorded information from patient interviews and the medical record. After the implant procedure, all patients were admitted to the hospital overnight for clinical monitoring. Patients were examined by the nurse clinician and by the attending cardiologist the day after the device implant. Patients with identified hematomas were followed daily while hospitalized and contacted by telephone after discharge. Late complications were identified by a patient being flagged if repeat hospital or emergency department visits occurred during the course of the study and by telephone follow-up interviews. The subjects of this prospective study were 200 consecutive patients at the University Hospital who underwent implantation of a PM, CRT, or an ICD. Clinical characteristics and use of anticoagulant/antiplatelet drugs were documented. All patients undergoing device-related surgery, including new device implants and device generator changes, were included in the analysis. All pacemakers and defibrillators were placed in a pre-pectoral pocket by experienced physicians (>40 implants, n=4). The majority of implants were performed solely by university staff clinical cardiac electrophysiologists, except for 4 implants by assistant lecturers (0.4%) and 46 implants performed by cardiology fellows under the direct supervision of an attending electrophysiologist (4.5%). Anticoagulation therapy was prescribed by the attending cardiologist and/or implanting physician and was not altered for the purpose of this study. Physicians maintained usual practice patterns. Study Protocol A hematoma was defined to be present if there was palpable swelling with fluctuation over the device generator. Hematomas were categorized into 2 groups: Type 1 did not extend beyond 1 cm past the device margin, and a type 2 hematoma extended beyond 1 cm past the device margin and caused significant strain on the incision site. The presence of a hematoma was determined by 1 of 2 experienced residents. 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). Hematomas were treated with external compression, temporary discontinuation of anticoagulation if not contraindicated, and rarely with a course of antibiotic therapy if local cellulitis was suspected. With this approach, device pocket evacuation was only performed in 4 cases. Table 1: Comparison between the two groups studied according to their devices. Group I: Total received local measures Group II: Did not receive local measures Group I (n = 50) Group II (n = 50) χ 2 MC p No. % No. % Device CRTD 0 0.0 2 4.0 4.541 0.311 CRTP 13 26.0 20 40.0 DDD 18 36.0 15 30.0 ICD 5 10.0 3 6.0 VVI 14 28.0 10 20.0 p: p-value for comparing between the studied groups *: Statistically significant at p ≤ 0.05 χ 2 : Chi-square test. MC: Monte Carlo Statistical Analysis Data was collected and entered prospectively into a computer database. The study hypothesis was tested by assessing the association of hematoma formation with prescription of anticoagulant and antiplatelet agents, including heparin, clopidogrel, and aspirin. To derive a list of other possible factors associated with hematoma formation, a range of clinical variables were recorded prospectively, and exploratory comparisons were performed. Categorical variables, including presence of hematoma and the 3 clopidogrel subgroups (“off,” “some,” or “on”), were summarized using frequencies and percentages and analyzed using the Pearson χ2 where appropriate; otherwise, a Fisher exact test was used. As the continuous variables were skewed (i.e., nonnormally distributed), they were summarized using medians and interquartile ranges (IQR) and analyzed using the nonparametric Kruskal-Walli’s test. The student t test was used to analyze age because it was normally distributed. Multiple logistic regression analyses using backward elimination were completed to determine the first predictors of hematoma. The least significant variable was dropped at each step until only those variables with P < 0.05 remained. Included in the first step were primary prevention ICD, ASA use, any heparin use, and clopidogrel use. The concordance statistic (c), with its 95% confidence interval (CI) representing the area under the receiver operating characteristic curve, was also computed to assess the discriminatory ability of the fitted model. Odds ratios and corresponding 95% CI were also computed where appropriate. In multiple tests, the device implant indication, clopidogrel use, and vascular access variables were tested in different ways, with the type I error rate being adjusted to 0.05/6=0.0083, 0.05/7=0.0071, and 0.05/4=0.0125, respectively. Elsewhere, probability values less than α of 0.05 (probability of type I error) were considered statistically significant. Statistical analysis was performed using the SAS System for Windows version 9.2 (SAS Institute Inc., Cary, NC). Results Group I: 4 patients had grade I hematoma. 1 patient had grade II hematoma. No patient had grade 3 hematoma Group II: 6 patients had grade I, 2 had grade II, and 2 had grade III. P value in the 2 groups 1 and 11 was 0.537 Descriptive Group I: 38 patients (76%) are hypertensive, 28 patients (56%) are diabetic, 24 patients (48%) are smoker 3 patients(6%) are CKD, 22 patients (44%) have bleeding tendency,22 patients (44%) are HB less 10 p-value was (0.545),34 patient(68%) intake (dual antiplatelet and anticoagulation),2 patient (4%) liver function, 33patient (66%)are dyslipidemic Group II: 41 patients (82%) are hypertensive,26 patients (52%) are diabetic,28 patients (56%)are smokers, 2(4%)are CKD,29 patients (58%) have a bleeding tendency,23 patients (46%) are HB less than 10 P-value (0.545)a,38 patient (76%) intake (dual antiplatelet and oral coagulation) 32 patient(64%) are dyslipidemic Group I: 13 patients (26%) had CRTP,18 patients (36%) had DDD,5 patients (10%) had ICD,14 patients (28.0%) had VVI Group II: 2 patients (4%) had CRTD, 20 patients (40%) had CRTP,15 patients (30%) had DDD,3 patients (6%) had ICD, 10 patients (20%) VVI P value < 0.05 for 2 groups I &II Group 1: 46 (92%) patients had no hematoma, 4 (8%) patients had hematoma mild. Group 2: 5 (18%) patients had hematoma grade 1. 3 patients had hematoma grade 2, P value was < 0.001* Grading Group 1: 3(6%) patients had grade I hematoma. 1 (5%) patient had grade II hematoma. No patient had grade 111 hematoma Group 2: 5 patients (48.8) had grade I; 3 patients (34.1) had grade II; 2 patients (17.1) had grade III P value between the groups 0.537 Table (2): Comparison between the two studied groups according to hematoma incidence Group I (n = 50) Group II (n = 50) χ 2 p No. % No. % Hematoma incidence 52.174 * < 0.001 * Yes 4 8.0 10 20.0 Grading (n = 4) (n = 10) Grade I 3 80.0 5 48.8 1.293 MC p= 0.537 Grade II 1 20.0 3 34.1 Grade III 0 0.0 2 17.1 χ 2 : Chi-square test MC: Monte Carlo p: p-value for comparing between the studied groups *: Statistically significant at p ≤ 0.05 Group I: Total received local measures Group II: Did not receive local measures Discussion Pocket hematomas are the most common result of CIED insertion, which can lead to longer in-hospital stays (3.6 days), higher hospitalization expenses (21%), and higher overall mortality. To reduce the occurrence and severity of pocket hematomas after CIED implantation, various therapeutic and prevention techniques have been implemented ( 17 – 51 ). The current study showed that, regarding the predictors of hematoma formation, only hypertension patients and low baseline Hb less than 10g were found to be predictors. There was no significant difference between the group with DM, smoking, and dyslipidemic patients. Regarding the use of local measures (bipolar diathermy and local hydrogen peroxide application), among the 45 patients in group 1, 83.3% received local measures and had no hematoma incidence, and 9 patients who did not receive local measures had no hematoma. In group 2, 41 patients (89.1%) who did not receive local measures had hematomas. 5 patients were received local measures had hematoma incidence; most of the cases had grade I hematoma. There was a significant association between the incidence of hematoma and HB & local measures. In the study of Sridhar et al. ( 32 ), in multivariate regression, they noted that more complex pacemaker types, older age groups, congestive heart failure, and coagulopathy were the independent predictors of an increased risk of hematoma formation. However, Turagam et al. ( 41 ) revealed that univariable analysis for pocket hematoma on day 7 demonstrated no significant association with type of device implanted, clopidogrel, or procedure time. Conclusions The main results of the study revealed that Group I: 38 patients (76%) are hypertensive, 28 patients (56%) are diabetic, 24 patients (48%) are smokers, 3 patients (6%) have CKD, 22 patients (44%) have a bleeding tendency, 22 patients (44%) have HB less than 10 (p-value was 0.545), 34 patients (68%) were taking dual antiplatelets or anticoagulation, 2 patients (4%) had altered liver function, and 33 patients (66%) had dyslipidemia. Group II: 41 patients (82%) were hypertensive, 26 (52%) were diabetic, 28 (56%) were smokers, 2 (4%) had CKD, 29 (58%) had bleeding tendency, 23 (46%) are HB less than 10 p value (0.545), 38 (76%) were taking (dual antiplatelets or oral coagulation) 32 (64%) had dyslipidemia P value was in 2 groups in HB less than 10 was significant (0.545). Local measures to decrease the incidence of pocket hematoma were electrocautery and intra-pocket hydrogen peroxide. 45 patients (90%) in Group 1 did not have a hematoma, but there were four patients (8%) that had a mild hematoma only, and one had a grade 2 hematoma. Group 2: 9 (18%) had hematoma, 5 (10%) patients had hematoma grade 1. 2 patients had hematoma grade 2, and 2 patients had hematoma grade 3; the P value was < 0.05. No infections had happened except in one in the grade 3 hematoma. So total types 2 or 3 were 5/100 patients (2.5%). So, the use of electrocautery and intra-pocket hydrogen peroxide was beneficial in preventing hematoma. Abbreviations BMI body mass index CIEDs cardiac implantable electronic devices CTOPP Canadian Trial of Physiologic Pacing DOAC direct oral anticoagulant ICD implantable cardioverter-defibrillator NCDR National Cardiac Data Registry NOACs: non–vitamin K antagonist oral anticoagulants PM Pacemaker TIMI Thrombolysis In Myocardial Infarction UKPACE United Kingdom Pacing and Cardiovascular Events Declarations Ethics approval and consent to participate: This study was conducted in compliance with the ethical standards of the responsible institution on human subjects as well as with the Helsinki Declaration. Institutional Review Board Approval: The ethics department of our faculty of medicine approved the study protocol in 2022. Informed Consent: Written informed consent was taken from all patients. Consent for publication: All authors agree to publication. Availability of data and material: The master chart and patients’ files are available on request with Dr. MS. Competing interests: The authors declare that they have no competing interests." Conflict of Interest: There is no conflict of interest. Funding: Financial Disclosure or Funding: The study was done without any financial support from any agent. Authors' contributions: MIS idea and design of the work, the main operator. SR wrote the paper and submitted it. Sh. R.: Revised the thesis and paper. This was her master’s thesis. M. El revised the thesis and paper Acknowledgement: We thank all residents and technicians who helped in the implantation procedures of patients. References Harding, Melissa E. (2015). Cardiac Implantable Electronic Device Implantation. AACN Advanced Critical Care, 26(4), 312–319. doi: 10.1097/NCI.0000000000000112 Freeman JV , Wang Y , Curtis JP , Heidenreich PA , Hlatky MA . Physician procedure volume and complications of cardioverter-defibrillator implantation. 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Journal of arrhythmia. 2018 Dec;34(6):632-9. doi: 10.1002/joa3.12123 Beton O, Saricam E, Kaya H, Yucel H, Dogdu O, Turgut OO, Berkan O, Tandogan I, Yilmaz MB. Bleeding complications during cardiac electronic device implantation in patients receiving antithrombotic therapy: is there any value of local tranexamic acid?. BMC cardiovascular disorders. 2016 Dec;16(1):1-0. doi.10.1186/s12872-016-0251-1 Nammas W, Raatikainen MP, Korkeila P, Lund J, Ylitalo A, Karjalainen P, Virtanen V, Koivisto UM, Utriainen S, Vasankari T, Koistinen J. Predictors of pocket hematoma in patients on antithrombotic therapy undergoing cardiac rhythm device implantation: insights from the FinPAC trial. Annals of medicine. 2014 May 1;46(3):177-81. doi: 10.3109/07853890.2014.894285. Kanuri SH, Elbey MA, Atkins D, Jeffery C, Della Rocca DG, Kodwani N, Natale A, Gopinathannair R, Mahapatra S, Lakkireddy D. Prevention and Treatment Strategies for Pocket Hematomas During CIED Implantation: Pocket Management Systems and Other Adjuvant Interventions.2020. available at: https://www.hmpgloballearningnetwork.com/site/eplab/prevention-and-treatment-strategies-pocket-hematomas-during- Spighi L, Notaristefano F, Annunziata R, D" ammando M, Zingarini G, Verdecchia P, Cavallini C. P1187 Pocket-Hematoma after cardiac implantable electronic devices surgery: a single-centre study. EP Europace. 2020 Jun 1;22(Supplement_1):euaa162-302. 10.1161/CIRCEP.120.008372 Additional Declarations The authors declare no competing interests. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-6494106","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":445643611,"identity":"55eeba40-0f79-443c-acf6-0d478b061fc0","order_by":0,"name":"Mohamed Ibrahim Sanhoury","email":"","orcid":"https://orcid.org/0000-0002-6563-0607","institution":"Alexandria University","correspondingAuthor":false,"prefix":"","firstName":"Mohamed","middleName":"Ibrahim","lastName":"Sanhoury","suffix":""},{"id":445643808,"identity":"9dbd93ab-51fe-470f-bbd8-7dcda01e7a9c","order_by":1,"name":"Samir Rafla","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAz0lEQVRIiWNgGAWjYLCCigIGHn4QI6GAWC1nDBhkJBtAWgxI0GJjcADEIkaL/LSzDz8cMLDjMT6/OvHDAwMGeX6xA/i1GNxON5Y4YJDMY3bj7WYJoMMMZ85OIKBFOo1B+oMBM1DL2Q0gLQkGtwlokZ+dxvzjgEE9j/GMs5t/EKWF4XYaG9Bhh3kM+Hu3EWeLAVCLxQGD4zwSN3i3WSQYSBD2C8hhNw5UVNvz95/dfPNHhY08vzQhh8GBBFilBLHKQYD/ACmqR8EoGAWjYCQBAHIwQeUiQZSxAAAAAElFTkSuQmCC","orcid":"https://orcid.org/0000-0001-8688-6532","institution":"Alexandria University","correspondingAuthor":true,"prefix":"","firstName":"Samir","middleName":"","lastName":"Rafla","suffix":""},{"id":445644435,"identity":"fb2a8f35-69d7-4d11-b81a-71cef926491d","order_by":2,"name":"Sherouk Ramzy","email":"","orcid":"https://orcid.org/0009-0006-2698-5698","institution":"Alexandria University","correspondingAuthor":false,"prefix":"","firstName":"Sherouk","middleName":"","lastName":"Ramzy","suffix":""},{"id":445644436,"identity":"971886a3-d16c-4e60-903c-d7574975e595","order_by":3,"name":"Mohamed ElFiky","email":"","orcid":"https://orcid.org/0000-0003-4659-1697","institution":"Alexandria University","correspondingAuthor":false,"prefix":"","firstName":"Mohamed","middleName":"","lastName":"ElFiky","suffix":""}],"badges":[],"createdAt":"2025-04-21 08:36:14","currentVersionCode":1,"declarations":{"humanSubjects":true,"vertebrateSubjects":false,"conflictsOfInterestStatement":false,"humanSubjectEthicalGuidelines":true,"humanSubjectConsent":true,"humanSubjectClinicalTrial":false,"humanSubjectCaseReport":false,"vertebrateSubjectEthicalGuidelines":false},"doi":"10.21203/rs.3.rs-6494106/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6494106/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":81095999,"identity":"879e9ed7-cfca-4077-8f73-10b26caf6f85","added_by":"auto","created_at":"2025-04-22 07:59:04","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":380930,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6494106/v1/05252014-2d50-445d-9c51-ed05cac2ecb5.pdf"}],"financialInterests":"The authors declare no competing interests.","formattedTitle":"\u003cp\u003eTips for preventing hematoma and infection after pacemaker implantation\u003c/p\u003e","fulltext":[{"header":"Introduction","content":"\u003cp\u003ePocket hematoma is a recognized common complication after placement of a permanent pacemaker (PM) or implantable cardioverter-defibrillator (ICD). Pocket hematoma is associated with local discomfort and an increased risk of infection and may require surgical intervention (1-15).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eMajor Adverse Events of Cardioverter-Defibrillator Implantation as Defined in the National Cardiac Data Registry\u0026mdash;Implantable Cardioverter Defibrillator Registry (2). \u0026nbsp;A separate analysis of the National Cardiac Data Registry (NCDR). Many patients are on antiplatelet or anticoagulant therapy for reasons such as having atrial fibrillation or stents implanted or other indications such as pulmonary emboli. The risk associated with discontinuing these medications results in an increased risk for stent thrombosis or stroke with possible catastrophic consequences. This risk needs to be considered when device implantation is considered and balanced against the significant increase in the prevalence of pocket hematoma, requiring pocket revision seen in patients on ASA, clopidogrel, or dual-antiplatelet therapy (16-29). Hematoma grading and interventions based on clinical findings (15)\u003c/p\u003e\n\u003cp\u003eGrade 1: Ecchymosis or mild effusion in the pocket with no swelling or pain to the device pocket (watchful waiting)\u003c/p\u003e\n\u003cp\u003eGrade 2: Large effusion in the pocket leading to swelling and causing functional impairment or pain to the device pocket\u003c/p\u003e\n\u003cp\u003eGrade 3: Any pocket hematoma requiring reoperation and/or resulting in prolongation of hospitalization (defined as extended hospitalization or rehospitalization for \u0026gt;24 hours and/or need for interruption of OAC).\u003c/p\u003e\n\u003cp\u003eFuture Applications: In recent trials, pocket compression vests were demonstrated to lower the risk of pocket hematomas and infections in patients having CIED implantation (38).\u003c/p\u003e\n\u003cp\u003eAim: To find ways to minimize infection and identify clinical factors that lead to hematoma formation after PM or ICD device implantation, the study was conducted.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003ePatients were prospectively enrolled in the study after the successful completion of device implantation. Consent was obtained, and patients were then followed through hospital discharge. Data were obtained prospectively by a clinical nurse specialist who recorded information from patient interviews and the medical record. After the implant procedure, all patients were admitted to the hospital overnight for clinical monitoring. Patients were examined by the nurse clinician and by the attending cardiologist the day after the device implant. Patients with identified hematomas were followed daily while hospitalized and contacted by telephone after discharge. Late complications were identified by a patient being flagged if repeat hospital or emergency department visits occurred during the course of the study and by telephone follow-up interviews.\u003c/p\u003e\n\u003cp\u003eThe subjects of this prospective study were 200 consecutive patients at the University Hospital who underwent implantation of a PM, CRT, or an ICD.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eClinical characteristics and use of anticoagulant/antiplatelet drugs were documented.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAll patients undergoing device-related surgery, including new device implants and device generator changes, were included in the analysis.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAll pacemakers and defibrillators were placed in a pre-pectoral pocket by experienced physicians (\u0026gt;40 implants, n=4).\u003c/p\u003e\n\u003cp\u003eThe majority of implants were performed solely by university staff clinical cardiac electrophysiologists, except for 4 implants by assistant lecturers (0.4%) and 46 implants performed by cardiology fellows under the direct supervision of an attending electrophysiologist (4.5%).\u003c/p\u003e\n\u003cp\u003eAnticoagulation therapy was prescribed by the attending cardiologist and/or implanting physician and was not altered for the purpose of this study. Physicians maintained usual practice patterns.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eStudy Protocol\u003c/p\u003e\n\u003cp\u003eA hematoma was defined to be present if there was palpable swelling with fluctuation over the device generator. Hematomas were categorized into 2 groups: Type 1 did not extend beyond 1 cm past the device margin, and a type 2 hematoma extended beyond 1 cm past the device margin and caused significant strain on the incision site. The presence of a hematoma was determined by 1 of 2 experienced residents.\u003c/p\u003e\n\u003cp\u003eClinically 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).\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;Hematomas were treated with external compression, temporary discontinuation of anticoagulation if not contraindicated, and rarely with a course of antibiotic therapy if local cellulitis was suspected. With this approach, device pocket evacuation was only performed in 4 cases.\u003c/p\u003e\n\u003cp\u003eTable 1: Comparison between the two groups studied according to their devices.\u003c/p\u003e\n\u003cp\u003eGroup I:\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Total received local measures\u003c/p\u003e\n\u003cp\u003eGroup II: \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; Did not receive local measures \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"537\" class=\"fr-table-selection-hover\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 151px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" style=\"width: 125px;\"\u003e\n \u003cp\u003eGroup I\u003cbr\u003e\u0026nbsp;(n = 50)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" style=\"width: 125px;\"\u003e\n \u003cp\u003eGroup II\u003cbr\u003e\u0026nbsp;(n = 50)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" style=\"width: 68px;\"\u003e\n \u003cp\u003e\u0026chi;\u003csup\u003e2\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" style=\"width: 68px;\"\u003e\n \u003cp\u003e\u003csup\u003eMC\u003c/sup\u003ep\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 151px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 62px;\"\u003e\n \u003cp\u003eNo.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 62px;\"\u003e\n \u003cp\u003e%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 62px;\"\u003e\n \u003cp\u003eNo.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 62px;\"\u003e\n \u003cp\u003e%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 151px;\"\u003e\n \u003cp\u003eDevice\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 62px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 62px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 62px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 62px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 68px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 68px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 151px;\"\u003e\n \u003cp\u003eCRTD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e0.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e4.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"5\" style=\"width: 68px;\"\u003e\n \u003cp\u003e4.541\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"5\" style=\"width: 68px;\"\u003e\n \u003cp\u003e0.311\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 151px;\"\u003e\n \u003cp\u003eCRTP\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e13\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e26.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e20\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e40.0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 151px;\"\u003e\n \u003cp\u003eDDD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e18\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e36.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e15\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e30.0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 151px;\"\u003e\n \u003cp\u003eICD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e10.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e6.0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 151px;\"\u003e\n \u003cp\u003eVVI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e14\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e28.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e10\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e20.0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003ep: p-value for comparing between the studied groups\u003c/p\u003e\n\u003cp\u003e*: Statistically significant at p \u0026le; 0.05 \u0026nbsp;\u0026chi;\u003csup\u003e2\u003c/sup\u003e: \u0026nbsp;Chi-square test. MC: Monte Carlo\u003c/p\u003e\n\u003cp\u003eStatistical Analysis Data was collected and entered prospectively into a computer database. The study hypothesis was tested by assessing the association of hematoma formation with prescription of anticoagulant and antiplatelet agents, including heparin, clopidogrel, and aspirin. To derive a list of other possible factors associated with hematoma formation, a range of clinical variables were recorded prospectively, and exploratory comparisons were performed. Categorical variables, including presence of hematoma and the 3 clopidogrel subgroups (\u0026ldquo;off,\u0026rdquo; \u0026ldquo;some,\u0026rdquo; or \u0026ldquo;on\u0026rdquo;), were summarized using frequencies and percentages and analyzed using the Pearson \u0026chi;2 where appropriate; otherwise, a Fisher exact test was used. As the continuous variables were skewed (i.e., nonnormally distributed), they were summarized using medians and interquartile ranges (IQR) and analyzed using the nonparametric Kruskal-Walli\u0026rsquo;s test. The student t test was used to analyze age because it was normally distributed. Multiple logistic regression analyses using backward elimination were completed to determine the first predictors of hematoma. The least significant variable was dropped at each step until only those variables with P \u0026lt; 0.05 remained. Included in the first step were primary prevention ICD, ASA use, any heparin use, and clopidogrel use. The concordance statistic (c), with its 95% confidence interval (CI) representing the area under the receiver operating characteristic curve, was also computed to assess the discriminatory ability of the fitted model. Odds ratios and corresponding 95% CI were also computed where appropriate. In multiple tests, the device implant indication, clopidogrel use, and vascular access variables were tested in different ways, with the type I error rate being adjusted to 0.05/6=0.0083, 0.05/7=0.0071, and 0.05/4=0.0125, respectively. Elsewhere, probability values less than \u0026alpha; of 0.05 (probability of type I error) were considered statistically significant. Statistical analysis was performed using the SAS System for Windows version 9.2 (SAS Institute Inc., Cary, NC).\u0026nbsp;\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eGroup I: 4 patients had grade I hematoma. 1 patient had grade II hematoma. No patient had grade 3 hematoma Group II: 6 patients had grade I, 2 had grade II, and 2 had grade III. P value in the 2 groups 1 and 11 was 0.537\u003c/p\u003e \u003cp\u003eDescriptive\u003c/p\u003e \u003cp\u003eGroup I: 38 patients (76%) are hypertensive, 28 patients (56%) are diabetic, 24 patients (48%) are smoker 3 patients(6%) are CKD, 22 patients (44%) have bleeding tendency,22 patients (44%) are HB less 10 p-value was (0.545),34 patient(68%) intake (dual antiplatelet and anticoagulation),2 patient (4%) liver function, 33patient (66%)are dyslipidemic Group II: 41 patients (82%) are hypertensive,26 patients (52%) are diabetic,28 patients (56%)are smokers, 2(4%)are CKD,29 patients (58%) have a bleeding tendency,23 patients (46%) are HB less than 10 P-value (0.545)a,38 patient (76%) intake (dual antiplatelet and oral coagulation) 32 patient(64%) are dyslipidemic Group I: 13 patients (26%) had CRTP,18 patients (36%) had DDD,5 patients (10%) had ICD,14 patients (28.0%) had VVI Group II: 2 patients (4%) had CRTD, 20 patients (40%) had CRTP,15 patients (30%) had DDD,3 patients (6%) had ICD, 10 patients (20%) VVI P value\u0026thinsp;\u0026lt;\u0026thinsp;0.05 for 2 groups I \u0026amp;II Group 1: 46 (92%) patients had no hematoma, 4 (8%) patients had hematoma mild. Group 2: 5 (18%) patients had hematoma grade 1. 3 patients had hematoma grade 2, P value was \u0026lt;\u0026thinsp;0.001* Grading Group 1: 3(6%) patients had grade I hematoma. 1 (5%) patient had grade II hematoma. No patient had grade 111 hematoma Group 2: 5 patients (48.8) had grade I; 3 patients (34.1) had grade II; 2 patients (17.1) had grade III P value between the groups 0.537\u003c/p\u003e \u003cp\u003eTable\u0026nbsp;(2): Comparison between the two studied groups according to hematoma incidence\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"No\" id=\"Tabb\" border=\"1\"\u003e \u003ccolgroup cols=\"7\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003eGroup I (n\u0026thinsp;=\u0026thinsp;50)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003eGroup II (n\u0026thinsp;=\u0026thinsp;50)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eχ\u003csup\u003e2\u003c/sup\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003ep\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNo.\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e%\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNo.\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e%\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHematoma incidence\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e52.174\u003csup\u003e*\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003csup\u003e*\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e20.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGrading\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;10)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGrade I\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e80.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e48.8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003e1.293\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003e\u003csup\u003eMC\u003c/sup\u003ep=\u003c/p\u003e \u003cp\u003e0.537\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGrade II\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e20.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e34.1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGrade III\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e17.1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"7\"\u003eχ\u003csup\u003e2\u003c/sup\u003e: Chi-square test MC: Monte Carlo\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003ep: p-value for comparing between the studied groups\u003c/p\u003e \u003cp\u003e*: Statistically significant at p\u0026thinsp;\u0026le;\u0026thinsp;0.05\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eGroup I: Total received local measures\u003c/p\u003e\u003cp\u003eGroup II: Did not receive local measures\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003ePocket hematomas are the most common result of CIED insertion, which can lead to longer in-hospital stays (3.6 days), higher hospitalization expenses (21%), and higher overall mortality. To reduce the occurrence and severity of pocket hematomas after CIED implantation, various therapeutic and prevention techniques have been implemented (\u003cspan additionalcitationids=\"CR18 CR19 CR20 CR21 CR22 CR23 CR24 CR25 CR26 CR27 CR28 CR29 CR30 CR31 CR32 CR33 CR34 CR35 CR36 CR37 CR38 CR39 CR40 CR41 CR42 CR43 CR44 CR45 CR46 CR47 CR48 CR49 CR50\" citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR51\" class=\"CitationRef\"\u003e51\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe current study showed that, regarding the predictors of hematoma formation, only hypertension patients and low baseline Hb less than 10g were found to be predictors.\u003c/p\u003e \u003cp\u003eThere was no significant difference between the group with DM, smoking, and dyslipidemic patients.\u003c/p\u003e \u003cp\u003eRegarding the use of local measures (bipolar diathermy and local hydrogen peroxide application), among the 45 patients in group 1, 83.3% received local measures and had no hematoma incidence, and 9 patients who did not receive local measures had no hematoma. In group 2, 41 patients (89.1%) who did not receive local measures had hematomas. 5 patients were received local measures had hematoma incidence; most of the cases had grade I hematoma. There was a significant association between the incidence of hematoma and HB \u0026amp; local measures.\u003c/p\u003e \u003cp\u003eIn the study of Sridhar et al. (\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e), in multivariate regression, they noted that more complex pacemaker types, older age groups, congestive heart failure, and coagulopathy were the independent predictors of an increased risk of hematoma formation.\u003c/p\u003e \u003cp\u003eHowever, Turagam et al. (\u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e) revealed that univariable analysis for pocket hematoma on day 7 demonstrated no significant association with type of device implanted, clopidogrel, or procedure time.\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003eThe main results of the study revealed that\u003c/p\u003e \u003cp\u003eGroup I: 38 patients (76%) are hypertensive, 28 patients (56%) are diabetic, 24 patients (48%) are smokers, 3 patients (6%) have CKD, 22 patients (44%) have a bleeding tendency, 22 patients (44%) have HB less than 10 (p-value was 0.545), 34 patients (68%) were taking dual antiplatelets or anticoagulation, 2 patients (4%) had altered liver function, and 33 patients (66%) had dyslipidemia.\u003c/p\u003e \u003cp\u003eGroup II: 41 patients (82%) were hypertensive, 26 (52%) were diabetic, 28 (56%) were smokers, 2 (4%) had CKD, 29 (58%) had bleeding tendency, 23 (46%) are HB less than 10 p value (0.545), 38 (76%) were taking (dual antiplatelets or oral coagulation) 32 (64%) had dyslipidemia P value was in 2 groups in HB less than 10 was significant (0.545). Local measures to decrease the incidence of pocket hematoma were electrocautery and intra-pocket hydrogen peroxide.\u003c/p\u003e \u003cp\u003e45 patients (90%) in Group 1 did not have a hematoma, but there were four patients (8%) that had a mild hematoma only, and one had a grade 2 hematoma. Group 2: 9 (18%) had hematoma, 5 (10%) patients had hematoma grade 1. 2 patients had hematoma grade 2, and 2 patients had hematoma grade 3; the P value was \u0026lt;\u0026thinsp;0.05. No infections had happened except in one in the grade 3 hematoma. So total types 2 or 3 were 5/100 patients (2.5%). So, the use of electrocautery and intra-pocket hydrogen peroxide was beneficial in preventing hematoma.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eBMI body mass index\u003c/p\u003e\n\u003cp\u003eCIEDs cardiac implantable electronic devices\u003c/p\u003e\n\u003cp\u003eCTOPP Canadian Trial of Physiologic Pacing\u003c/p\u003e\n\u003cp\u003eDOAC direct oral anticoagulant\u003c/p\u003e\n\u003cp\u003eICD implantable cardioverter-defibrillator\u003c/p\u003e\n\u003cp\u003eNCDR National Cardiac Data Registry\u003c/p\u003e\n\u003cp\u003eNOACs: non–vitamin K antagonist oral anticoagulants\u003c/p\u003e\n\u003cp\u003ePM Pacemaker\u003c/p\u003e\n\u003cp\u003eTIMI Thrombolysis In Myocardial Infarction\u003c/p\u003e\n\u003cp\u003eUKPACE United Kingdom Pacing and Cardiovascular Events\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003eEthics approval and consent to participate:\u0026nbsp;\u003cem\u003eThis study was conducted in compliance with the ethical standards of the responsible institution on human subjects as well as with the Helsinki Declaration.\u003c/em\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eInstitutional Review Board Approval: The ethics department of our faculty of medicine approved the study protocol in 2022.\u003c/p\u003e\n\u003cp\u003eInformed Consent: Written informed consent was taken from all patients.\u003c/p\u003e\n\u003cp\u003eConsent for publication: All authors agree to publication.\u003c/p\u003e\n\u003cp\u003eAvailability of data and material: The master chart and patients\u0026rsquo; files are available on request with Dr. MS.\u003c/p\u003e\n\u003cp\u003eCompeting interests: The authors declare that they have no competing interests.\u0026quot;\u003c/p\u003e\n\u003cp\u003eConflict of Interest: There is no conflict of interest.\u003c/p\u003e\n\u003cp\u003eFunding: Financial Disclosure or Funding: The study was done without any financial support from any agent.\u003c/p\u003e\n\u003cp\u003eAuthors\u0026apos; contributions:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eMIS idea and design of the work, the main operator.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eSR wrote the paper and submitted it.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eSh. R.: Revised the thesis and paper. This was her master\u0026rsquo;s thesis.\u003c/p\u003e\n\u003cp\u003eM. El \u0026nbsp; revised the thesis and paper\u003c/p\u003e\n\u003cp\u003eAcknowledgement: We thank all residents and technicians who helped in the implantation procedures of patients.\u003cbr\u003e\u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eHarding, Melissa E. (2015). Cardiac Implantable Electronic Device Implantation. AACN Advanced Critical Care, 26(4), 312\u0026ndash;319. doi: 10.1097/NCI.0000000000000112\u003c/li\u003e\n\u003cli\u003eFreeman JV , Wang Y , Curtis JP , Heidenreich PA , Hlatky MA . Physician procedure volume and complications of cardioverter-defibrillator implantation. Circulation. 2012 ; 125 ( 1 ): 57 \u0026ndash; 64 . 10.1161/CIRCULATIONAHA.111.046995\u003c/li\u003e\n\u003cli\u003ePrutkin JM, Reynolds MR, Bao H, et al. Rates of and factors associated with infection in 200 909 Medicare implantable cardioverter-defibrillator implants: results from the National Cardiovascular Data Registry. Circulation. 2014 ; 130 ( 13 ): 1037 \u0026ndash; 1043 . 10.1161/CIRCULATIONAHA.114.009081\u003c/li\u003e\n\u003cli\u003eArmaganijan LV , Toff WD , Nielsen JC , et al. Are elderly patients at increased risk of complications following pacemaker implantation? A meta-analysis of randomized trials. Pacing Clin Electrophysiol. 2012 ; 35 ( 2 ): 131 \u0026ndash; 134 . 10.1111/j.1540-8159.2011.03240.x.\u003c/li\u003e\n\u003cli\u003eAnderson DJ, Podgorny K, Berrios-Torres SI, et al. Strategies to prevent surgical site infections in acute care hospitals: 2014 update. Infect Control Hosp Epidemiol. 2014 ; 35 ( suppl 2 ): S66 \u0026ndash; S88 .10.1086/676022\u003c/li\u003e\n\u003cli\u003eBratzler DW , Dellinger EP , Olsen KM , et al. Clinical practice guidelines for antimicrobial prophylaxis in surgery. Surg Infect (Larchmt). 2013 ; 14 ( 1 ): 73 \u0026ndash; 156 . doi: 10.2146/ajhp120568.\u003c/li\u003e\n\u003cli\u003eKutinsky IB , Jarandilla R , Jewett M , Haines DE . Risk of hematoma complications after device implant in the clopidogrel era . Circ Arrhythm Electrophysiol. 2010 ; 3 ( 4 ): 312 \u0026ndash; 318 . 10.1161/CIRCEP.109.917625\u003c/li\u003e\n\u003cli\u003eS. Pepplinkhuizen1 \u0026middot; N. Kors1 \u0026middot; J. A. de Veld1 \u0026middot; L. A. Dijkshoorn1 \u0026middot; N. R. Bijsterveld1 \u0026middot; A. de Weger, et.al. Antithrombotic therapy and the risk of pocket hematoma after subcutaneous implantable cardioverter‑defibrillator implantation. Journal of Interventional Cardiac Electrophysiology. 16 January 2025. https://doi.org/10.1007/s10840-024-01973-x\u003c/li\u003e\n\u003cli\u003eThal S , Moukabary T , Boyella R , et al. The relationship between warfarin, aspirin, and clopidogrel continuation in the peri-procedural period and the incidence of hematoma formation after device implantation. Pacing Clin Electrophysiol. 2010 ; 33 ( 4 ): 385 \u0026ndash; 388 . 10.1111/j.1540-8159.2009.02674.x\u003c/li\u003e\n\u003cli\u003eWiegand UK , LeJeune D , Boguschewski F , et al. Pocket hematoma after pacemaker or implantable cardioverter defibrillator surgery: influence of patient morbidity, operation strategy, and perioperative antiplatelet/anticoagulation therapy. Chest. 2004 ; 126 ( 4 ): 1177 \u0026ndash; 1186 . doi: 10.1378/chest.126.4.1177.\u003c/li\u003e\n\u003cli\u003ePiromchai P , Vatanasapt P , Reechaipichitkul W , Phuttharak W , Thanaviratananich S . Is the routine pressure dressing after thyroidectomy necessary? A prospective randomized controlled study . BMC Ear Nose Throat Disord. 2008; 8: 1. doi: 10.1186/1472-6815-8-1\u003c/li\u003e\n\u003cli\u003eNichols CI, Vose JG. Incidence of bleeding-related complications during primary implantation and replacement of cardiac implantable electronic devices.J Am Heart Assoc. 2017; 6:e004263. doi: 10.1161/JAHA.116.004263.\u003c/li\u003e\n\u003cli\u003eNammas W, Raatikainen MJP, Korkeila P, Lund J, Ylitalo A, Karjalainen P, Virtanen V, et al. Predictors of pocket hematoma in patients on antithrombotic therapy undergoing cardiac rhythm device implantation: Insights from the FinPAC trial. Ann Med 2014; 46: 177\u0026ndash; 181. 10.3109/07853890.2014.894285\u003c/li\u003e\n\u003cli\u003eAiraksinen KE, Korkeila P, Lund J, Ylitalo A, Karjalainen P, Virtanen V, Raatikainen P, et al. Safety of pacemaker and implantable cardioverter defibrillator implantation during uninterrupted warfarin treatment\u0026mdash;The FinPAC study. Int J Cardiol 2013; 168: 3679\u0026ndash; 3682. 10.1016/j.ijcard.2013.06.022\u003c/li\u003e\n\u003cli\u003eBirnie DH, Healey JS, Wells GA, Verma A, Tang AS, Krahn AD, Simpson CS, et al. Pacemaker or defibrillator surgery without interruption of anticoagulation. N Engl J Med 2013; 368: 2084\u0026ndash; 2093. 10.1056/NEJMoa1302946\u003c/li\u003e\n\u003cli\u003eDe Sensi F, Paneni F, Addonisio L, Breschi M, Miracapillo G, Severi S. Intrinsic bleeding risk in patients with uninterrupted oral anticoagulation undergoing cardiac implantable electronic device procedures: A pilot study. Int J Cardiol 2014; 176: 1420\u0026ndash; 1422.\u003c/li\u003e\n\u003cli\u003eTompkins C, Cheng A, Dalal D, Brinker JA, Leng CT, Marine JE, Nazarian S, et al. Dual antiplatelet therapy and heparin \u0026ldquo;bridging\u0026rdquo; significantly increase the risk of bleeding complications after pacemaker or implantable cardioverter defibrillator device implantation. J Am Coll Cardiol 2010; 55: 2376\u0026ndash; 2382.\u003c/li\u003e\n\u003cli\u003eLi HK, Chen FC, Rea RF, Asirvatham SJ, Powell BD, Friedman PA, Shen WK, et al. 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Clinically significant pocket hematoma increases long-term risk of device infection: BRUISE CONTROL INFECTION Study. J Am Coll Cardiol 2016; 67:1300\u0026ndash;1308. https://doi.org/10.1016/j.jacc.2016.01.009\u003c/li\u003e\n\u003cli\u003eIshibashi K, Miyamoto K, Kamakura T, et al. Risk factors associated with bleeding after multi antithrombotic therapy during implantation of cardiac implantable electronic devices. Heart Vessels 2017; 32:333\u0026ndash;340. doi: 10.1007/s00380-016-0879-x.\u003c/li\u003e\n\u003cli\u003eProietti R, Porto I, Levi M, et al. Risk of pocket hematoma in patients on chronic anticoagulation with warfarin undergoing electrophysiological device implantation: a comparison of different peri-operative management strategies. Eur Rev Med Pharmacol Sci 2015; 19:1461\u0026ndash;1479. PMID: 25967723\u003c/li\u003e\n\u003cli\u003eBirnie DH, Healey JS, Wells GA, et al. Pacemaker or defibrillator surgery without interruption of anticoagulation. 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Circ Cardiovasc Qual Outcomes. 2011;4:549\u0026ndash;556. doi: 10.1161/CIRCOUTCOMES.110.959205.\u003c/li\u003e\n\u003cli\u003ePeterson P.N., Daugherty S.L., Wang Y., Vidaillet H.J., Heidenreich P.A., Curtis J.P. National Cardiovascular Data R. Gender differences in procedure-related adverse events in patients receiving implantable cardioverter-defibrillator therapy. Circulation. 2009;119:1078\u0026ndash;1084. doi: 10.1161/CIRCULATIONAHA.108.793463.\u003c/li\u003e\n\u003cli\u003eSridhar AR, Yarlagadda V, Kanmanthareddy A, et al. Incidence, predictors and outcomes of hematoma after ICD implantation: An analysis of a nationwide database of 85,276 patients. Indian Pacing Electrophysiol J. 2016;16(5):159-164. doi: 10.1016/j.ipej.2016.10.005\u003c/li\u003e\n\u003cli\u003eBirnie D.H., Healey J.S., Wells G.A., Verma A., Tang A.S., Krahn A.D. Pacemaker or defibrillator surgery without interruption of anticoagulation. N Engl J Med. 2013;368:2084\u0026ndash;2093. doi: 10.1056/NEJMoa1302946\u003c/li\u003e\n\u003cli\u003eTischenko A., Gula L.J., Yee R., Klein G.J., Skanes A.C., Krahn A.D. Implantation of cardiac rhythm devices without interruption of oral anticoagulation compared with perioperative bridging with low-molecular-weight heparin. Am Heart J. 2009;158:252\u0026ndash;256. DOI: 10.1016/j.ahj.2009.06.005\u003c/li\u003e\n\u003cli\u003eCheng A., Nazarian S., Brinker J.A., Tompkins C., Spragg D.D., Leng C.T. Continuation of warfarin during pacemaker or implantable cardioverter-defibrillator implantation: a randomized clinical trial. Heart Rhythm. 2011;8:536\u0026ndash;540. doi: 10.1016/j.hrthm.2010.12.016. \u003c/li\u003e\n\u003cli\u003eOzcan K.S., Osmonov D., Yildirim E., Altay S., Turkkan C., Ekmekci A. Hematoma complicating permanent pacemaker implantation: the role of periprocedural antiplatelet or anticoagulant therapy. J Cardiol. 2013;62:127\u0026ndash;130. doi: 10.1016/j.jjcc.2013.03.002\u003c/li\u003e\n\u003cli\u003eOhlow MA, Buchter B, Brunelli M, Lauer B, Schreiber M, Geller JC. [Prevention of pocket-related complications following heart rhythm device implantation. D-Stat Hemostat\u0026trade; versus vacuum drainage]. Herzschrittmacherther Elektrophysiol. 2015;26(1):45-51. doi: 10.1007/s00399-015-0349-7\u003c/li\u003e\n\u003cli\u003eMilic DJ, Perisic ZD, Zivic SS, et al. Prevention of pocket related complications with fibrin sealant in patients undergoing pacemaker implantation who are receiving anticoagulant treatment. Europace. 2005;7(4):374-379. doi: 10.1016/j.eupc.2005.03.007.\u003c/li\u003e\n\u003cli\u003eMukherjee SS, Saggu D, Chennapragada S, Yalagudri S, Nair SG, CalamburNarasimhan. Device implantation for patients on antiplatelets and anticoagulants: use of suction drain. Indian Heart J. 2018;70(Suppl 3):S389-s393. doi: 10.1016/j.ihj.2017.12.009.\u003c/li\u003e\n\u003cli\u003eAwada H, Geller JC, Brunelli M, Ohlow MA. Pocket related complications following cardiac electronic device implantation in patients receiving anticoagulation and/or dual antiplatelet therapy: prospective evaluation of different preventive strategies. J Interv Card Electrophysiol. 2019;54(3):247-255. doi: 10.1007/s10840-018-0488-y.\u003c/li\u003e\n\u003cli\u003eTuragam MK, Nagarajan DV, Bartus K, Makkar A, Swarup V. Use of a pocket compression device for the prevention and treatment of pocket hematoma after pacemaker and defibrillator implantation (STOP-HEMATOMA-I). J Interv Card Electrophysiol. 2017;49(2):197-204. doi: 10.1007/s10840-017-0235-9\u003c/li\u003e\n\u003cli\u003eLakkireddy D, Bartus K, Nagarajan V, et al. Abstract 20633: Use of novel compression device reduces the incidence of pocket hematoma in anticoagulated patients receiving implantable electronic cardiac devices: a pilot study. Circulation. 2016;134(Suppl_1):A20633. doi: 10.1007/s10840-017-0235-9.\u003c/li\u003e\n\u003cli\u003eBudano C, Garrone P, Castagno D, et al. Same-day CIED implantation and discharge: is it possible? The E-MOTION trial (Early MObilization after pacemaker implantaTION). Int J Cardiol. 2019;288:82-86. doi: 10.1016/j.ijcard.2019.04.020\u003c/li\u003e\n\u003cli\u003eStiles MK, Dabbous OH, Fox KA. Bleeding events with antithrombotic therapy in patients with unstable angina or non-ST-segment elevation myocardial infarction; insights from a large clinical practice registry (GRACE) Heart Lung Circ. 2008;17:5\u0026ndash;8. doi: 10.1016/j.hlc.2007.02.096\u003c/li\u003e\n\u003cli\u003eEssebag V, Verma A, Healey JS, et al. Clinically significant pocket hematoma increases long-term risk of device infection. J Am Coll Cardiol. 2016;67(11):1300-1308. https://doi.org/10.1016/j.jacc.2016.01.009\u003c/li\u003e\n\u003cli\u003eFerretto S, Mattesi G, Migliore F, Susana A, De Lazzari M, Iliceto S, Leoni L, Bertaglia E. Clinical predictors of pocket hematoma after cardiac device implantation and replacement. Journal of Cardiovascular Medicine. 2020 Feb 1;21(2):123-7. doi: 10.2459/JCM.0000000000000914.\u003c/li\u003e\n\u003cli\u003eKorkerdsup T, Ngarmukos T, Sungkanuparph S, Phuphuakrat A. Cardiac implantable electronic device infection in the cardiac referral center in Thailand: incidence, microbiology, risk factors, and outcomes. Journal of arrhythmia. 2018 Dec;34(6):632-9. doi: 10.1002/joa3.12123\u003c/li\u003e\n\u003cli\u003eBeton O, Saricam E, Kaya H, Yucel H, Dogdu O, Turgut OO, Berkan O, Tandogan I, Yilmaz MB. Bleeding complications during cardiac electronic device implantation in patients receiving antithrombotic therapy: is there any value of local tranexamic acid?. BMC cardiovascular disorders. 2016 Dec;16(1):1-0. doi.10.1186/s12872-016-0251-1\u003c/li\u003e\n\u003cli\u003eNammas W, Raatikainen MP, Korkeila P, Lund J, Ylitalo A, Karjalainen P, Virtanen V, Koivisto UM, Utriainen S, Vasankari T, Koistinen J. Predictors of pocket hematoma in patients on antithrombotic therapy undergoing cardiac rhythm device implantation: insights from the FinPAC trial. Annals of medicine. 2014 May 1;46(3):177-81. doi: 10.3109/07853890.2014.894285.\u003c/li\u003e\n\u003cli\u003eKanuri SH, Elbey MA, Atkins D, Jeffery C, Della Rocca DG, Kodwani N, Natale A, Gopinathannair R, Mahapatra S, Lakkireddy D. Prevention and Treatment Strategies for Pocket Hematomas During CIED Implantation: Pocket Management Systems and Other Adjuvant Interventions.2020. available at: https://www.hmpgloballearningnetwork.com/site/eplab/prevention-and-treatment-strategies-pocket-hematomas-during-\u003c/li\u003e\n\u003cli\u003eSpighi L, Notaristefano F, Annunziata R, D\u0026quot; ammando M, Zingarini G, Verdecchia P, Cavallini C. P1187 Pocket-Hematoma after cardiac implantable electronic devices surgery: a single-centre study. EP Europace. 2020 Jun 1;22(Supplement_1):euaa162-302. 10.1161/CIRCEP.120.008372\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"Alexandria University","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"anticoagulants, clopidogrel, coronary artery disease, dabigatran, heparin, pocket hematoma, CIED, PPM, pocket compression vest, pocket management systems","lastPublishedDoi":"10.21203/rs.3.rs-6494106/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6494106/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground:\u003c/strong\u003e The purpose of the study was to identify the clinical factors associated with hematoma formation after PM or ICD device implantation and how to prevent it.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods:\u003c/strong\u003e Fifty patients (group 1) were subjected to local measures such as electrocautery use and intra-pocket hydrogen peroxide (3%, diluted 50% with NaCl) application. Fifty other patients (group II) were implanted with the device during an era when cauterization was not available or not used, and no such solution was considered at that time.\u003c/p\u003e\n\u003cp\u003eA hematoma was defined as palpable swelling with fluctuance over the device generator. Hematomas were categorized into 3 groups: Type 1 did not extend beyond 1 cm past the device margin, and type 2, hematoma, extended beyond 1 cm past the device margin. Clinically significant device-pocket hematoma (type 3) when hematoma needed evacuation. With this approach, device pocket evacuation was only performed in 4 cases. Good compression was adopted in all cases.\u003c/p\u003e\n\u003cp\u003eIn Group 1 there were four patients (8%) that had a mild hematoma and a grade 2 hematoma on one. Group 2: 9 (18%) had hematoma, and 5 (10 %) patients had hematoma grade 1. 2 patients had hematoma grade 2, and 2 patients had hematoma grade 3; the P value was \u0026lt;0.05. No infections had happened except in one in the grade 3 hematoma. So total types 2 or 3 were 5/100 patients (2.5%). So, the use of electrocautery and intra-pocket hydrogen peroxide was beneficial in preventing hematoma and infection.\u003c/p\u003e","manuscriptTitle":"Tips for preventing hematoma and infection after pacemaker implantation","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-04-22 07:50:55","doi":"10.21203/rs.3.rs-6494106/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"5b76b71b-7bcd-4998-b82c-d1b25ea99b19","owner":[],"postedDate":"April 22nd, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":47488316,"name":"Critical Care \u0026 Emergency Medicine"}],"tags":[],"updatedAt":"2025-04-22T07:50:55+00:00","versionOfRecord":[],"versionCreatedAt":"2025-04-22 07:50:55","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6494106","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6494106","identity":"rs-6494106","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}