Peri-procedural Anticoagulation and the Incidence of Haematoma Formation after Permanent Pacemaker Implantation in the Elderly

doi:10.1016/j.hlc.2010.08.011

Heart, Lung and Circulation

Volume 19, Issue 12, December 2010, Pages 706-712

https://doi.org/10.1016/j.hlc.2010.08.011 Get rights and content

Background

Haematoma formation is a recognised complication after permanent pacemaker (PPM) implantation. The contribution of peri-procedural anticoagulation to the risk of haematoma formation is unclear.

Method

The records of 518 consecutive patients, mean age 76.9 ± 9.8 years, receiving their first PPM (2004–2007) in a single tertiary referral centre were reviewed. Follow-up was complete for 506 patients (97.7%) up to six weeks. Haematomas were diagnosed clinically, and further subdivided according to the need for evacuation.

Results

There were 27 instances of haematoma formation in 25 patients (4.9%) with 19 requiring drainage or evacuation. Twenty-one of the 25 patients who developed a haematoma had stopped warfarin and received bridging therapeutic anticoagulation pre- and post-PPM. The incidence of haematoma was significantly greater in those receiving peri-operative therapeutic anticoagulation (26.9% vs 0.9%, p < 0.001), but was unaffected by the use of anti-platelet therapy. Most haematomas developed in patients whose heparin was recommenced within 24 hours of implantation. The development of haematoma post-PPM increased median hospital stay significantly (p < 0.001). The main indication for anticoagulation in these patients was atrial fibrillation (79.5%) and most of these patients had a low to intermediate risk of peri-procedural thromboembolic events.

Conclusion

Peri-operative therapeutic anticoagulation is associated with more than 25-fold increase in haematoma formation post-pacemaker implantation. The risk-benefit ratio of therapeutic anticoagulation should be carefully considered, particularly in patients with a low risk of thromboembolic events.

Introduction

Implantation of a permanent cardiac pacemaker (PPM) is a relatively common procedure. Recently performed surveys have demonstrated that the implantation of PPMs is increasing steadily in Australia, with 590 PPM implantations per million population in 2005, a 20% increase from four years earlier [1]. Similar trends regarding PPM implantation have been reported in international studies [2].

Pocket haematoma formation is one of the most common and well-recognised complications following implantation of a PPM, with an incidence of 0.6–2.6% reported in the literature [3], [4], [5], [6], [7]. A recent audit of PPM implantation in New South Wales reported an overall complication rate of 11.9% with most complications resulting from lead displacements and pocket haematoma formation [7]. Relatively few contemporary studies have assessed PPM-related haematoma formation in detail or the clinical factors associated with this complication. One recent report indicated a high risk of haematoma formation with bridging therapy [8].

We conducted a single centre, retrospective analysis of the incidence and predictors of haematoma formation following PPM implantation, with a specific focus on the impact of anticoagulation and anti-platelet therapy.

Section snippets

Study Population

We retrospectively reviewed electronic discharge records and inpatient clinical records up to six weeks after PPM implantation of all patients (n = 518) who underwent implantation of a first PPM at Concord Repatriation General Hospital (a tertiary care facility of the Sydney South West Area Health Service) between January 2004 and December 2007 inclusive. This retrospective review was approved by the hospital Human Ethics Committee. We included both acute and elective presentations for PPM

Baseline Characteristics

A total of 518 patients received a new permanent pacemaker (PPM) at our centre between 2004 and 2007. Complete data to six weeks post-operatively was obtained in 506 patients (97.7%) with 12 patients being lost to follow-up. Our population was predominantly elderly (mean age was 76.9 ± 9.8 years) with a slight male predominance. The most common indication for pacing was high degree atrio-ventricular block (31.4%), followed by atrial fibrillation with a slow ventricular response rate (21.1%), and

Discussion

Pacemaker insertion is a common, lifesaving, procedure with a significant risk of post-operative complications. As part of the implantation process, the fascial layers within the pacemaker pocket are not sutured and remain unopposed [10]. Resultant haematoma formation results in patient discomfort, is associated with increased risk of infection and prolongs length of post-operative hospital stay. We report a clear relationship between haematoma formation and peri-operative anticoagulation,

Conclusion

Peri-operative anticoagulation is associated with a 25-fold increase in haematoma formation post-pacemaker implantation. This results in a significant increase in morbidity, length of stay and overall burden to health care costs. A bridging anticoagulation strategy accounted for all haematomas in patients anticoagulated for non-valvular atrial fibrillation. The need for bridging anticoagulation should be considered carefully, and reserved for patients at highest risk of peri-operative stroke or

Acknowledgements

We would like to acknowledge the advice and support provided by Professor J. Peat with our statistical analysis. No external financial support declared.

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Perioperative Management of Vitamin K Antagonists and Direct Oral Anticoagulants: A Systematic Review and Meta-analysis
2023, Chest
The management of patients who are receiving chronic oral anticoagulation therapy and require an elective surgery or an invasive procedure is a common clinical scenario.
What is the best available evidence to support the development of American College of Chest Physicians guidelines on the perioperative management of patients who are receiving long-term vitamin K agonist (VKA) or direct oral anticoagulant (DOAC) and require elective surgery or procedures?
A literature search including multiple databases from database inception through July 16, 2020, was performed. Meta-analyses were conducted when appropriate.
In patients receiving VKA (warfarin) undergoing elective noncardiac surgery, shorter (< 3 days) VKA interruption is associated with an increased risk of major bleeding. In patients who required VKA interruption, heparin bridging (mostly with low-molecular-weight heparin [LMWH]) was associated with a statistically significant increased risk of major bleed, representing a very low certainty of evidence (COE). Compared with DOAC interruption 1 to 4 days before surgery, continuing DOACs may be associated with higher risk of bleeding demonstrated in some, but not all studies. In patients who needed DOAC interruption, bridging with LMWH may be associated with a statistically significant increased risk of bleeding, representing a low COE.
The certainty in the evidence supporting the perioperative management of anticoagulants remains limited. No high-quality evidence exists to support the practice of heparin bridging during the interruption of VKA or DOAC therapy for an elective surgery or procedure, or for the practice of interrupting VKA therapy for minor procedures, including cardiac device implantation, or continuation of a DOAC vs short-term interruption of a DOAC in the perioperative period.
Management of Perioperative Anticoagulation for Device Implantation
2018, Cardiac Electrophysiology Clinics
Citation Excerpt :
Although most bleeding events associated with PPM or ICD implantation are pocket hematomas, there are other potential hemorrhagic complications to consider. Retroperitoneal bleeding, gastrointestintal bleeding, pericardial tamponade, and access site hematomas have all been described.10,13,26–28,32,33 Their frequency, however, is typically much less than 1%.
Hematoma complicating permanent pacemaker implantation: The role of periprocedural antiplatelet or anticoagulant therapy
2013, Journal of Cardiology
Citation Excerpt :
Thus, the authors thought that limited arm movement and periodical compression on pacemaker site during the first week of operation may reduce the rate of hematoma formation. In the literature, there are many reports about the risk of the bridging to intravenous heparin or LMWH [10,15,16]. Our findings were in contrast to these reports and LMWH bridging does not increase the rate of hematoma formation.
Periprocedural management of antiplatelet or anticoagulant therapy at the time of device implantation remains controversial.
We reviewed all cases for whom a pacemaker was implanted in our institution between January 2008 and June 2009. In addition, beginning in June 2009, we prospectively collected data from all patients admitted to our institution, for whom a pacemaker was placed. Clinical characteristics and anticoagulant/antiplatelet drug use were evaluated.
A total of 574 patients underwent a permanent pacemaker implantation. Of these, 20 patients (3.6%, 9 women) experienced a hematoma on pacemaker pocket site. Patients were aged between 35 and 79 years (mean 60.6 ± 12 years). The frequency of hematoma formation was significantly higher (p < 0.001) in those who used warfarin than in those who did not. Aspirin (ASA), clopidogrel, dual antiplatelet therapy (DAT), and bridging to low-molecular-weight heparin (LMWH) did not increase the risk of hematoma formation (p > 0.05). Eleven pocket revisions for hematoma evacuation were needed in 9 patients (1.6%), six of whom were on warfarin therapy (p > 0.05). Co-morbidities were similar in patients with and without hematoma (p > 0.05).
The frequency of hematoma is within acceptable ranges after pacemaker placement. The use of warfarin seriously increases the risk of hematoma. Bridging to LMWH safely prevents thromboembolism.
Peri-operative management of patients with anti-platelet or anticoagulation treatment
2012, Revista Colombiana de Cardiologia
El tratamiento del paciente que recibe terapias que afectan la hemostasia normal (anticoagulantes y/o antiagregantes plaquetarios) y que será sometido a un procedimiento quirúrgico, es uno de los retos que se presentan cada vez con mayor frecuencia en los servicios de cardiología. La toma de la mejor opción terapéutica en este grupo de pacientes requiere un profundo conocimiento sobre los riesgos de sangrado en caso de continuarse el tratamiento, frente a los riesgos de trombosis o embolismo en caso de suspenderlo. Por tradición, esa decisión se ha basado más en el temor al riesgo de sangrado, por lo cual en muchos casos se ha suspendido dicha terapia de manera innecesaria. En los últimos años, la aparición de la evidencia que indica que no sólo no es alto el riesgo de sangrado sino que además la continuación de estos medicamentos en muchos casos disminuye desenlaces adversos mayores, ha llevado a replantear esta conducta. En este artículo se revisará la evidencia actual existente al respecto y se suministrarán pautas que permitan la toma de una decisión adecuada.
Treatment of patients receiving therapies that affect normal hemostasis (anticoagulants and / or antiplatelet aggregators) and that will undergo surgery, is one of the challenges that arise with increasing frequency in the cardiology services. Making the best therapeutic option in these patients requires a thorough understanding of the risks of bleeding in case of continuing the treatment against the risks of thrombosis or embolism in case of stopping it. By tradition, this decision has been based more on fear to the risk of bleeding, whereby in many cases this therapy has been suspended unnecessarily. In recent years, the emergence of evidence indicates that the risk of bleeding is not high and that continuation of these drugs in many cases reduce major adverse outcomes. This has led to redefine this behavior. In this article we review the current evidence available on the subject and provide guidelines that allow making a right decision.
Device surgery in the anticoagulated patient: The Goldilocks principle
2012, Heart Rhythm
Perioperative management of antithrombotic therapy. Antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines
2012, Chest
Citation Excerpt :
Urologic surgery and procedures consisting of transurethral prostate resection, bladder resection, or tumor ablation; nephrectomy; or kidney biopsy in part due to untreated tissue damage (after prostatectomy) and endogenous urokinase release32–34 Pacemaker or implantable cardioverter-defibrillator device implantation in which separation of infraclavicular fascial layers and lack of suturing of unopposed tissues within the device pocket may predispose to hematoma development35–38 Colonic polyp resection, typically of large (ie, > 1-2 cm long) sessile polyps, in which bleeding may occur at the transected stalk following hemostatic plug release39
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.

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¹: Contributed equally to this work.

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Original ArticlePeri-procedural Anticoagulation and the Incidence of Haematoma Formation after Permanent Pacemaker Implantation in the Elderly

Background

Method

Results

Conclusion

Introduction

Section snippets

Study Population

Baseline Characteristics

Discussion

Conclusion

Acknowledgements

Heart Lung Circ

Am J Cardiol

J Am Coll Cardiol

Am J Cardiol

J Am Coll Cardiol

Chest

J Thromb Haemost

J Am Coll Cardiol

J Thorac Cardiovasc Surg

J Am Coll Cardiol

Cardiac device implantation in the United States from 1997 through 2004: a population-based analysis

J Gen Intern Med

Original Article
Peri-procedural Anticoagulation and the Incidence of Haematoma Formation after Permanent Pacemaker Implantation in the Elderly