Prevention and Treatment Strategies for Pocket Hematomas During CIED Implantation: Pocket Management Systems and Other Adjuvant Interventions

Abstract

Pocket hematomas are one of the most common complications in patients undergoing implantable cardioverter-defibrillator (ICD) or pacemaker (PPM) implantation. The overall incidence of pocket hematomas in patients with cardiac implantable electronic devices (CIEDs) has been reported to be around 1-5%. The occurrence of pocket hematomas has been associated with increased incidence of other complications such as device infections, thromboembolism, increased hospital stay, increased health care costs, and high morbidity and mortality. Numerous interventions have been researched and trialed to minimize occurrence as well as decrease the severity of pocket hematomas when they do occur. Prior strategies include fibrin sealant, suction drains, electrocautery, administration of regenerated cellulose, pro-coagulant applications such as the D-Stat Flowable Hemostat (Teleflex) comprised of collagen and thrombin, as well as devices and strategies that provide compression to the pocket. 

In this review, we will summarize recent literature regarding pocket hematomas, increased risk factors in developing pocket hematomas, and complications and adverse events resulting from pocket hematomas, as well as discuss various adjuvant therapies for prevention and treatment. The review will also include a summary outlining the benefits of utilizing pocket compression vests by providing direct compression and minimizing vascular ooze into the pocket. Specific benefits will include ease of use, optimal clinical outcomes (specifically, the potential to reduce and minimize the severity of pocket hematomas and subsequent device infections), patient satisfaction, and the economic advantages of using pocket compression vests over other interventions. 

Key words: pocket hematoma, CIED, PPM, pocket compression vest, pocket management systems

CIED and Procedure Complications

There has been an upward trend in the number of patients in the United States receiving CIEDs.^1-6 Some of the important risk factors for developing complications at the time of CIED placement include angina, use of antiarrhythmic therapy, patient co-morbidities, age, increased number of previous procedures, and low implanter volume.⁷ Major complications for patients undergoing CIED implantation and generator changes include device infection, lead revision, electric storm, pulmonary edema, hemothorax, pneumothorax, cardiac perforation, myocardial infarction, valve damage, stroke, pericardial effusion, and cardiac arrest.^7-9 Minor complications of CIED placement include incision infection, conduction block, phlebitis, and pocket hematomas.^7-9

Pocket hematomas are the most common complication post CIED placement and are associated with longer in-hospital stays (3.6 days), higher hospitalization costs (21%), and increased overall mortality.^9-11 Various treatment and prevention strategies have been implemented to try to decrease the occurrence and severity of patients developing pocket hematomas following CIED implantation. This review briefly summarizes the recent literature regarding prevention and management strategies of pocket hematomas. It also describes the usefulness of adjuvant therapies, including pocket compression vests such as the PocketVest (BVS Medical) in preventing pocket hematomas and associated adverse clinical outcomes. 

Pocket Hematomas

Pocket hematomas occur most commonly in association with CIED implantation and are considered a significant risk factor (7 fold) for device infections and subsequent hospitalizations within 1 year of CIED implantation.^{12, 13} The incidence of developing a pocket hematoma post CIED procedure is around 1-9.5%.^{8, 9, 14-17} The underlying mechanisms for device infections in patients with pocket hematomas include pressure-induced tissue necrosis, skin breakdown, and decreased ability to fight local infections.¹⁸ Another underlying mechanism is that the presence of clinically significant hematoma (CSH) provides a fertile ground for prolonged Staphylococcus colonization (skin flora), which is found in approximately 48% of device infections.^{13, 19}

Risk Factors for Development Pocket Hematomas

The risk of developing pocket hematomas increases with higher age groups, congestive heart failure, renal failure, thrombocytopenia, and coagulopathy.^{9, 20} Renal failure increases the risk of pocket hematoma due to uremia-induced platelet dysfunction.^{9, 21} The higher risk for pocket hematomas in elderly patients can be attributed to loose subcutaneous tissue and poor muscle tone, likely contributing to subsequent pooling of blood around the device.⁹ The higher incidence of pocket hematomas in congestive heart failure patients can be explained by the presence of co-morbidities, including those that require patients to be on long-term anticoagulant therapy.⁹ According to Yalcin et al, other risk factors that can lead to the development of pocket hematomas include the experience of the operator, type of surgical technique, type of device, antiplatelet/anticoagulant therapy, subcutaneous fatty tissue, and BMI <23 kg/m².¹⁷ The risk of pocket hematomas increases substantially with biventricular vs single-chamber devices, which is likely due to the higher complexity of the procedures and larger pocket sizes.^{10, 11, 22, 23} Interestingly, some studies showed that women experience more CIED procedure-related complications, including pocket hematomas, compared to men.^{24, 25}

Anticoagulants, Antiplatelet Therapy, and Pocket Hematomas

The risk of developing peri-procedural complications such as pocket hematomas during and post-CIED implantation included pre-existing thrombocytopenia, heparin bridging therapy (14%), and dual antiplatelet therapy (DAT) (16.2%).^{9, 14, 20, 26-28} Aspirin and newer antiplatelet drugs (clopidogrel and ticlopidine), and both intravenous and subcutaneous heparin, are particularly associated with an increased risk of developing a pocket hematoma.^29-31 According to Dai et al, the risk of developing a pocket hematoma in the first 24 to 48 hours on DAT (19.3%) was clinically significantly higher than aspirin alone therapy (3.2%).²⁹ Accordingly, a research study demonstrated that clopidogrel withdrawal for 3 to 4 days before the surgical procedure decreased the risk of developing hematomas and bleeding complications due to platelet regeneration during the window period.¹⁴

According to Kutinsky et al, the administration of heparin is particularly associated with the development of pocket hematomas and longer hospital stay (by 20-24%).^{14, 32, 33} The risk of pocket hematomas was increased 20-fold with the usage of intravenous heparin (22%), subcutaneous heparin (22.6%) with patients experiencing late complications, surgical interventions, and longer hospital stays.¹⁴ In a clinical observational study performed from July 2010 to July 2012, the risk of developing a pocket hematoma was 5-fold higher in the low-molecular-weight heparin group (16.47%)as compared to patients receiving DAT (3.49%).³⁴

Patients on warfarin and on direct oral anticoagulant therapy have been found to have a lower risk of developing pocket hematomas than those on DAT therapy. In a study by Thal et al, patients on warfarin had a lower risk at 0.9% compared to patients receiving DAT at 2.5%.²⁷ Similarly, patients on warfarin experienced a lower incidence of developing pocket hematomas and shorter hospital stays as compared to patients who underwent heparin bridging at the time of CIED placement.^{16, 20, 35, 36} This was also demonstrated in the BRUISE CONTROL trial, which showed the risk of developing a pocket hematoma on interrupted warfarin therapy (3.5%) was lower compared to patients undergoing heparin bridging therapy (16%) in the 2 weeks following CIED placement.¹³ The BRUISE CONTROL-2 trial demonstrated patients with continued and interrupted direct oral anticoagulant (DOAC) therapy had similar rates (2.1%) of developing pocket hematomas and lower complication rates during CIED implantation as the warfarin group in the BRUISE CONTROL trial.³⁷

Complications and Adverse Effects of Pocket Hematomas

Post CIED implantation, it is possible for large pocket hematomas (Figure 1A) to form and, if not adequately managed, lead to late complications such as large abscess formation (Figure 1B), incisional dehiscence (Figure 1C), and clot-induced dehiscence (Figure 1D).^38-41 Pocket hematomas can also lead to minor complications such as patient discomfort and swelling. More concerning are major complications such as hematoma infection, cardiac device infection, pocket revision, and the need for multiple patient interventions. Major complications result in prolongation of hospital stay (9.1 days vs 5.5 days; P<.001), economic loss (ie, loss of wages), and increased health care costs ($56,545 vs $47,015; P<.001).⁹ The mortality rate associated with the occurrence of pocket hematoma is approximately .4-1.0%, mainly due to infection and additional interventions required to manage it.⁹ The incidence of in-hospital mortality with the development of pocket hematoma is around 1.3%.¹¹

Various Treatment Strategies for Preventing Pocket Hematomas

Researchers have previously tested a few therapeutic interventions for reducing the risk of developing pocket hematoma during CIED placement with mixed results. Prior strategies include fibrin sealant, suction drains, electrocautery, administration of regenerated cellulose, pro-coagulant applications such as the D-Stat Flowable Hemostat (Teleflex) comprised of collagen and thrombin, as well as devices and strategies that provide compression to the pocket. Administration of D-Stat (combination of thrombin and collagen) into the pectoral pocket did not result in decreased incidence of pocket hematomas in patients receiving anticoagulant or antiplatelet therapy at the time of CIED placement.^{42, 43} However, one study demonstrated that the administration of fibrin sealant in patients receiving anticoagulants reduced the incidence of developing pocket hematomas during CIED placement compared to the control group.⁴⁴ Other interventions that can be beneficial in preventing pocket hematomas include electrocautery, local tranexamic acid, oxidized regenerated cellulose, and pressure dressings.^45-47 Administration of epinephrine during ICD implantation actually was seen to increase the risk of developing pocket hematomas as compared to patients receiving saline therapy.⁴⁸ Placement of a sterile close wound suction drain following ICD implantation resulted in reduced incidence of developing pocket hematoma in patients receiving anticoagulants.⁴⁹ A recent case by Valentino et al showed that a patient with a history of diabetes who developed pocket hematoma following ICD placement was successfully treated with an elastic pressure adhesive dressing.⁵⁰ The compression tool was designed to provide adequate and sustained pressure at the pocket site to prevent the occurrence of pocket hematoma and skin erosions following CIED implantation.⁵¹ According to Awada et al, a compression device (Premofix, Andanza) and a hemostatic gelatin sponge (Stypro, Ariston Dental) reduced the occurrence of pocket hematoma and infections in patients receiving anticoagulants and DAT following CIED implantation.⁵²

Future Requirement of Pocket Compression Devices 

While some of the above inventions have shown some promise, there continues to be mixed results and higher costs associated with their use. Prior strategies have also focused more on invasive techniques as well as use of pro-coagulant, thrombin, and collagen strategies. Because of this, there is a need for more focus on the development of compression tools that are non-invasive and cost effective, and that provide maximum patient comfort. There is a need for a novel pocket compression device that has the ability to provide adequate and sustained pressure at the pocket site to prevent hematoma and skin erosions with the ability to modify the degree of vascular compression over the pocket hematoma. Future compression devices should not only help prevent the occurrence of pocket hematomas, but be developed to provide adequate breathability, cooling to reduce capillary blood flow to reduce pain and swelling at the operational incision site, and support to enable healing.

Pocket Compression Vests

A pocket compression vest (PocketVest CIED Pocket Management System)was recently designed to standardized post-operative care following CIED implantation with the goal to prevent and reduce pocket hematomas and infections.⁵³

Design of Pocket Compression Vest

The pocket compression vest is designed to enhance patient comfort while delivering adequate pressure to reduce the risk of a pocket hematoma. It is mainly made with a hypoallergenic foam core (latex free) and surrounded by highly elastic fabric which allows for maximizing airflow, minimizing sweat, and enhancing dryness.⁵³ It is a neoprene breathable compression vest available in 2 sizes (XS/M and L/XXL), and is composed of 2 straps, a shoulder strap and chest strap.¹⁸ The shoulder strap portion attaches to the shoulder blade and anterior part of the chest that overlies the cardiac device pocket (Figures 2A-B).¹⁸ The chest strap portion circumferentially holds the vest together and overlaps over the front end of the vest (Figures 2A-B).¹⁸ The inner surface of the vest that faces the anterior chest wall has a support wedge that can be used to apply sufficient pressure on the pocket as required and can be applied directly over the incision site (Figures 2A-B).¹⁸ It can be easily and quickly applied by simple hook and adjustments for proper positioning and comfort.⁵³ It is designed with a focus on providing patient comfort that in turn increases patient compliance, enhancing wound healing, which in turn helps facilitation of decreased infection rates, shorter hospital stays, and the possible reduction of health care costs.⁵³ It also provides a standardized approach to post-procedural care in comparison to pressure bandages, which can vary on how they are applied depending on who applies the pressure bandage post procedure. 

Utilization of Pocket Compression Vest

The pocket compression vest is applied directly after the device incision pocket is closed and bandaged. After 2 hours of pocket compression vest use, patients are assessed for hematoma formation. In the absence of a hematoma, the patient wears the pocket compression vest for an additional two hours and then is discontinued. If the development of a pocket hematoma is seen at the initial assessment after 2 hours of use, a supporting wedge is applied in 2-hour increments with a gap of 30 minutes of rest. This on-off application protocol (2 hours on – 30 minutes off) will continue until the pocket hematoma has completely healed.¹⁸ The duration and degree of compression can be individualized to each patient and clinical scenario.¹⁸ Based on current literature, it is recommended that patients at risk or seen with developing pocket hematomas utilize the pocket compression vest for 24 hours and up to 48 hours if the clinician feels the patient would benefit from longer duration of use. However, according to current manufacturer guidelines, it is recommended to wear the pocket vest with wedge for 24 to 48 hours right away after implantation to prevent the risk of pocket hematoma.

Previous Studies Showing Efficacy with Utilization of Pocket Compression Vests 

The goal of use of pocket compression vests are to reduce local complications such as swelling, erythema, pain, and major complications that result in the need for surgical hematoma during the post-operative period.¹⁸ This translates into decreased morbidity, shortened hospital stays, reduced health care costs, and better patient clinical outcomes.¹⁸

Use of pocket compression vests, such as the PocketVest CIED Pocket Management System, have been clinically proven to reduce pocket hematomas and subsequent pocket infections.^{18, 53} Potential clinical advantages with use of pocket compression vests include localized cooling, immobilization via arm/shoulder accessory, an integrated arm sling, and mild-moderate compression.⁵³ Its main functions are to maximize comfort, prevent complications, and improve patient outcomes (Figure 3).⁵³ According to Turagam et al, use of a post surgical pocket compression vest reduced the risk of developing moderate to large hematomas in patients undergoing CIED implantation even on uninterrupted anticoagulation therapy.¹⁸ According to Lakkireddy et al, use of a novel compression vest decreases the incidence of pocket hematoma and might in addition avoid the discontinuation of anticoagulant therapy in patients undergoing CIED implantation.⁵⁴

Future Applications

Recent studies have demonstrated the impact of the use of pocket compression vests in the prevention of pocket hematomas and subsequent infections for patients undergoing CIED implantation and generator changes. More studies are needed to determine the impact of pocket vest compression use in prevention of other complications, including wound separation and lead displacement.⁵³ Research is needed on optimization of the design of pocket compression vests, ie, with arm sling support allowing for early mobilization at 0 to 3 hours following CIED implantation to reduce the risk of intra-procedural complications and overall 24-month lead dislodgement.⁵⁵

Conclusions and Future Directions

Pocket hematomas are the most common complication post-CIED implantation that can lead to complications such as device infections, pocket revision, prolonged hospital stays, and economic losses. A number of interventions have been tried previously without much success. A pocket compression device, such as the PocketVest CIED Pocket Management System, has shown promise in preventing pocket hematomas by providing adequate compression, cooling, and immobilization, and preventing vascular ooze (Figure 3). These pocket compression devices are easy to use, have little risk, and facilitate patient comfort. It has been clinically proven to reduce local complications, decrease morbidity, and enhance clinical outcomes in previously conducted research studies. Future studies should be focused on the evaluation of its clinical efficacy in preventing pocket hematomas in larger clinical trials, particularly in patients receiving anticoagulant and antiplatelet therapy, as well as the impact on reducing wound separation and lead dislodgement. 

¹Arrhythmia Research Fellow, Kansas City Heart Rhythm Institute (KCHRI), Overland Park, Kansas;

²Executive Medical Director, KCHRI, Overland Park, Kansas; ³Fellow, Texas Heart Rhythm Institute, Austin, Texas; ⁴Internal Medicine Program Director, Overland Park Regional Medical Center, Overland Park, Kansas; ⁵Cardiac Electrophysiology Laboratory Director, KCHRI, Overland Park, Kansas; ⁶Executive Medical Director, Texas Heart Rhythm Institute, Austin, Texas; ⁷University of Minnesota, Minneapolis, Minnesota

Disclosures: Dr. Natale reports he is a consultant for Abbott, Baylis Medical, Biosense Webster, BIOTRONIK, Medtronic, and Boston Scientific. Dr. Gopinathannair reports he is a consultant/speaker for Abbott, Boston Scientific, ZOLL Medical, Pfizer, and Bristol-Myers Squibb, as well as a physician advisor for HealthTrust PG and Abiomed. Dr. Lakkireddy reports he is a consultant for Johnson & Johnson, Abbott, BIOTRONIK, Pfizer, Medtronic, and Boston Scientific. The other authors have no conflicts of interest to report regarding the content herein. Dr. Mahapatra reports a patent has been issued licensed on the PocketVest with royalties paid.

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